<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03250247</url>
  </required_header>
  <id_info>
    <org_study_id>201707130</org_study_id>
    <nct_id>NCT03250247</nct_id>
  </id_info>
  <brief_title>Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)</brief_title>
  <acronym>C-TRACT</acronym>
  <official_title>Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ontario Clinical Oncology Group (OCOG)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Luke's Hospital, Kansas City, Missouri</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the use of image-guided, endovascular therapy&#xD;
      (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease&#xD;
      severity and improve quality of life in patients with established disabling iliac-obstructive&#xD;
      post thrombotic syndrome (DIO-PTS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The rationale for performing the C-TRACT Trial is based upon:&#xD;
&#xD;
        1. the debilitating life impact of DIO-PTS upon patients, as cited in the U.S. Surgeon&#xD;
           General's 2008 Call to Action on DVT (95);&#xD;
&#xD;
        2. the inability of existing therapies to prevent or alleviate most cases of DIO-PTS;&#xD;
&#xD;
        3. the role of iliac vein obstruction and saphenous reflux in causing the severe&#xD;
           manifestations of DIO-PTS;&#xD;
&#xD;
        4. the ability of stent placement and endovenous ablation to eliminate obstruction and&#xD;
           reflux, respectively, to reduce PTS severity, and to improve QOL in preliminary studies;&#xD;
&#xD;
        5. the risks, costs, and uncertainties of this novel but invasive strategy;&#xD;
&#xD;
        6. the lack of consensus on whether EVT should be used for DIO-PTS;&#xD;
&#xD;
        7. the motivation of our established investigator team to answer this critical clinical&#xD;
           question.&#xD;
&#xD;
      We will determine if EVT should be routinely used to treat DIO-PTS. If so, this finding will&#xD;
      fundamentally change DIO-PTS practice towards more frequent use of EVT. If EVT proves&#xD;
      ineffective or unsafe, this finding will reduce or eliminate the use of potentially risky and&#xD;
      expensive procedures.&#xD;
&#xD;
      374 subjects with established DIO-PTS will be randomized in a 1:1 ratio to either EVT or&#xD;
      No-EVT treatment groups. All participants will receive standard PTS therapy. Subjects will be&#xD;
      enrolled over approximately 36 months in 20-40 U.S. Clinical Centers, and followed for 24&#xD;
      months. The study will take approximately 6 years to complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 2, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 29, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is an NIH-funded, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blinded Clinical assessments for PTS will be obtained at baseline (pre-randomization) and at the 6- month follow-up visits. Examining clinicians will complete PTS training to ensure accuracy across all Clinical Centers. The examiners for PTS must be blinded to the subjects' treatment allocation. Subjects will be reminded not reveal to clinic staff which therapy they received (EVT or No-EVT). Subjects should be examined in the afternoon (the later the better) to allow the symptoms and signs of PTS to manifest. The assessment is performed as follows:&#xD;
The subject should be asked to rate the 5 symptoms on the Villalta PTS scale for each leg, record his/her ratings on the CRF.&#xD;
The subject's legs should be unclothed and he/she should be seated facing the blinded clinician (nurse or physician).The 5 signs of PTS and VCSS measures will be recorded by the blinded clinician. Leg ulcers (if present) will be assessed and measured.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>PTS Severity</measure>
    <time_frame>over 6 months follow-up</time_frame>
    <description>374 patients with moderate to severe post thrombotic syndrome (PTS) and iliac vein obstruction will receive optimal PTS therapy. 50% of those patients will also receive endovenous therapy; modified antithrombotic therapy, including anti-platelet agent, iliac vein stenting, and endovenous ablation of refluxing saphenous veins if indicated. At 6 months post-randomization, venous clinical severity scores (VCSS) will be obtained and PTS severity will be evaluated.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">374</enrollment>
  <condition>Deep Vein Thrombosis</condition>
  <condition>Venous Stasis</condition>
  <condition>Venous Insufficiency</condition>
  <condition>Venous Leg Ulcer</condition>
  <condition>Venous Reflux</condition>
  <condition>Post Thrombotic Syndrome</condition>
  <arm_group>
    <arm_group_label>Endovascular Therapy - Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects (EVT and No-EVT Arms) will receive optimal PTS care. At each Clinical Center, this will be supervised by a physician experienced in managing PTS.&#xD;
Subjects randomized to EVT will receive the following:&#xD;
imaging-guided iliac vein stent placement, and&#xD;
endovenous ablation of refluxing saphenous vein(s), if the patient has truncal reflux and is still symptomatic.&#xD;
optimal PTS therapy: medical and compression, lifestyle interventions and venous ulcer care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Endovascular Therapy - Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All subjects will receive optimal PTS care as noted above.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stents</intervention_name>
    <description>US-guided puncture of vein, fluoroscopic monitoring of catheter/guidewire manipulations, baseline venogram of CFV through infrarenal IVC.&#xD;
Iliac vein should be pre-dilated to at least 12 mm. Bare, self-expanding stents made of elgiloy or nitinol legally marketed in the US for any indication and that are at least 12 mm in diameter should be used to recanalize the entire diseased segment of vein.&#xD;
The use of devices &gt; 14 mm is highly recommended for the iliac vein and dilated to at least 14 mm, unless compelling patient factors dictates dilatation to a smaller diameter.&#xD;
Balloon angioplasty of inflow veins.&#xD;
After successful iliac vein recanalization, patients who continue to be symptomatic beyond 2 weeks follow-up and who have valvular reflux in GSV, accessory GSV, anterolateral thigh circumflex, and/or SSV should be offered endovenous ablation.&#xD;
Any FDA-approved method may be used including radiofrequency or laser ablation, sclerotherapy or pharmacomechanical ablation.</description>
    <arm_group_label>Endovascular Therapy - Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Subjects must meet BOTH of these Criteria&#xD;
&#xD;
          1. Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease &gt;&#xD;
             or = 3 months duration in a leg with history of DVT, as determined by the site&#xD;
             principal investigator or a physician co-investigator; and b) substantial limitation&#xD;
             of daily activities or work capacity due to venous symptoms or an open venous ulcer,&#xD;
             per the same investigator.&#xD;
&#xD;
          2. Ipsilateral iliac vein obstruction documented within 12 months prior to screening by&#xD;
             either:&#xD;
&#xD;
               1. Occlusion or &gt;50% or = 50% stenosis of the iliac vein on venogram, CT venogram,&#xD;
                  MR venogram, or intravascular ultrasound (IVUS) or&#xD;
&#xD;
               2. Air plethysmography showing deep venous obstruction of the ipsilateral leg&#xD;
                  (reduced venous outflow fraction), and ultrasound showing echogenic material in&#xD;
                  the ipsilateral iliac vein and non-phasic continuous Doppler flow in the&#xD;
                  ipsilateral common femoral vein (CFV) in the presence of normal phasic Doppler&#xD;
                  flow in the contralateral CFV.&#xD;
&#xD;
        Exclusion Criteria: Subjects meeting any of these criteria will be excluded.&#xD;
&#xD;
          1. Age less than 18 years&#xD;
&#xD;
          2. Acute ipsilateral proximal DVT episode within the last 3 months, or acute&#xD;
             contralateral DVT for which thrombolytic therapy is planned&#xD;
&#xD;
          3. Lack of suitable inflow into the ipsilateral common femoral vein per the treating&#xD;
             physician&#xD;
&#xD;
          4. Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral&#xD;
             vein&#xD;
&#xD;
          5. Absence of PTS of at least moderate severity&#xD;
&#xD;
          6. Chronic arterial limb ischemia (ankle-brachial index &lt; 0.5 within the previous 1&#xD;
             month) in the ipsilateral leg (if peripheral arterial disease is present or suspected,&#xD;
             an ankle-brachial index should be obtained and documented)&#xD;
&#xD;
          7. Presence of open venous ulcer &gt; 50 cm2 area, suspicion for active ulcer infection, or&#xD;
             visualization of bone or tendon within the ulcer in the ipsilateral leg&#xD;
&#xD;
          8. Inability to tolerate endovascular procedure due to acute illness, or general health&#xD;
&#xD;
          9. Severe allergy to iodinated contrast refractory to steroid premedication&#xD;
&#xD;
         10. Known allergy to stent or catheter components&#xD;
&#xD;
         11. Hemoglobin &lt; 8.0 g/dl, uncorrectable INR &gt; 3.05, or platelet count &lt; 75,000/ml&#xD;
&#xD;
         12. Severe renal impairment (on chronic dialysis or estimated GFR &lt; 30 ml/min)&#xD;
&#xD;
         13. Disseminated intravascular coagulation or other major bleeding diathesis&#xD;
&#xD;
         14. Pregnancy (positive pregnancy test)&#xD;
&#xD;
         15. Life-expectancy &lt; 6 months or chronically non-ambulatory for reasons other than PTS&#xD;
&#xD;
         16. Inability to provide informed consent or to comply with study assessments&#xD;
&#xD;
        Note - patients who initially meet an exclusion criterion can have eligibility re-evaluated&#xD;
        on a subsequent occasion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suresh Vedantham, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Coordinating Center at Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mary Clare Derfler, RN MSN</last_name>
    <phone>314-973-0739</phone>
    <email>Derflerm@wustl.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patty Nieters, RN, BSN</last_name>
    <phone>314-362-3371</phone>
    <email>nietersp@wustl.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alabama - Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Vascular Institute</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alfonso Soriano</last_name>
      <phone>714-734-6220</phone>
      <email>alfonso.soriano@providence.org</email>
    </contact>
    <contact_backup>
      <last_name>Karla Garcia</last_name>
      <email>karla.garcia@providence.org</email>
    </contact_backup>
    <investigator>
      <last_name>Mahmood Razavi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kurt Openshaw, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stacey Tien, PA-C</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tiffany Wu, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bhavraj Khalsa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UCSF</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Khadija Siddiqua</last_name>
      <phone>415-476-4302</phone>
      <email>khadija.siddiqua@ucsf.edu</email>
    </contact>
    <contact_backup>
      <last_name>Maya Aslam</last_name>
      <email>maya.aslam@ucsf.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Kanti Kolli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vishal Kumar, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Evan Lehrman, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Leavitt, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caelan Watts</last_name>
      <email>celan.watts@yale.edu</email>
    </contact>
    <contact_backup>
      <last_name>Dana Alameddine</last_name>
      <email>dana.alameddine@yale.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Cassius Iyad Ochoa Chaar, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alfred Lee, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Henry Hsia, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Naiem Nassiri, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert Attaran, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Christiana Care Hospital</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19718</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ann Marie LeNoir</last_name>
      <phone>302-733-4112</phone>
      <email>annlenoir@christianacare.org</email>
    </contact>
    <investigator>
      <last_name>Daniel Leung, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Lankiewicz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Assaf Graif, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christopher Grilli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Demetrios Agriantonis, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>George Kimbiris, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Piedmont Heart Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Rush Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karl Villaneuva</last_name>
      <phone>312-563-7305</phone>
      <email>karl_villaneuva@rush.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jessica Daniel</last_name>
      <email>Jessica_Daniel@rush.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Jordan Tasse, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sreekumar Madassery, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shivi Jain, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bulent Arslan, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pamel Lofton</last_name>
      <phone>773-702-2537</phone>
      <email>plofton@radiology.bsd.uchicago.edu</email>
    </contact>
    <contact_backup>
      <last_name>Rosemary Uy-Palmer</last_name>
      <phone>773-702-6514</phone>
      <email>RUy-Palmer@radiology.bsd.uchicago.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Osmanuddin Ahmed, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jonathan Lorenz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jeffrey Leef, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thuong Van Ha, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rakesh Navuluri, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kenneth Cohen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NorthShore University Health System</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marisa Durante</last_name>
      <phone>847-570-2125</phone>
      <email>mdurante@northshore.org</email>
    </contact>
    <contact_backup>
      <last_name>Caitlin Nagy</last_name>
      <email>CNagy@northshore.org</email>
    </contact_backup>
    <investigator>
      <last_name>Alfonso Tafur, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Benjamin Lind, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristie Kennedy, MA</last_name>
      <phone>312-695-4023</phone>
      <email>kristie.kennedy@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Kush Desai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mark Eskandari, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Karlyn Martin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ramona Gupta, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lindsey Kalhagen, MMS, PA-C</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AMITA Health Adventist</name>
      <address>
        <city>LaGrange</city>
        <state>Illinois</state>
        <zip>60439</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Prairie Education and Research Cooperative</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62769</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Central DuPage</name>
      <address>
        <city>Winfield</city>
        <state>Illinois</state>
        <zip>60190</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Siji Mathachan</last_name>
      <phone>317-963-4786</phone>
      <email>simath@iu.edu</email>
    </contact>
    <investigator>
      <last_name>Sabah Butty, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas Casciana, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rakesh Mehta, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charlene Blanchard</last_name>
      <phone>507-538-8152</phone>
      <email>blanchard.charlene@mayo.edu</email>
    </contact>
    <investigator>
      <last_name>Newton Neidert, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Damon Houghton, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Haraldur Bjarnason, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pam McElroy</last_name>
      <email>pmcelroy@umc.edu</email>
    </contact>
    <contact_backup>
      <last_name>David Gordy, PhD</last_name>
      <phone>601-984-2541</phone>
      <email>dgordy@umc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Ajinkya Desai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laura Vick, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rahat Noor, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patty Nieters</last_name>
      <phone>314-362-3371</phone>
      <email>nietersp@wustl.edu</email>
    </contact>
    <contact_backup>
      <last_name>Mary Clare Derfler</last_name>
      <phone>314-747-2372</phone>
      <email>derflerm@wustl.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Suresh Vedantham, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Naganathan Mani, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pavan Kavali, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nassir Rostambeigi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexander Ushinsky, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elaine Majerus, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Morey Blinder, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amy Zhou, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kristen Sanfilippo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paula Vaughn, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Elizabeth's Hospital</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>New York University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian-Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eli Gussen</last_name>
      <phone>646-962-4638</phone>
      <email>mailto:Egg4001@med.cornell.edu</email>
    </contact>
    <contact_backup>
      <last_name>Irina Lipai</last_name>
      <email>irl2004@med.cornell.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Ronald Winokur, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria DeSancho, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Soo Rhee, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christopher Harnain, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hana Lim, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kimberly Scherer, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Akhilesh Sista, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Vermont Health Network - CVPH</name>
      <address>
        <city>Plattsburgh</city>
        <state>New York</state>
        <zip>12901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marjori Lahar</last_name>
      <phone>518-562-7521</phone>
      <email>mlahar@cvph.org</email>
    </contact>
    <investigator>
      <last_name>Steven Deso, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julio Lemos, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Staten Island Hospital</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stony Brook Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebekah Roten</last_name>
      <email>rebekah_roten@med.unc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Wendy Basinger</last_name>
      <email>wendy_basinger@med.unc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>William Marston, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Raj Kasthuri, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jobst Vascular Institute</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kris Hanus</last_name>
      <phone>419-291-7182</phone>
      <email>krisztina.hanus@promedica.org</email>
    </contact>
    <contact_backup>
      <last_name>Kelly Hallett</last_name>
      <phone>419-291-8792</phone>
      <email>Kelly.hallett@promedica.org</email>
    </contact_backup>
    <investigator>
      <last_name>John Fish, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zakaria Assi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Drew Oostra, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jihad Abbas, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Babatunde Oriowo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Seiwert, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gregory Kasper, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sophia Afridi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73014</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Sciences University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristen Bradigan</last_name>
      <email>kristen.bradigan@jefferson.edu</email>
    </contact>
    <contact_backup>
      <last_name>Philip Lee</last_name>
      <email>philip.lee@downstate.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Taki Galamis, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luis Eraso, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Robert Ford, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Pittsburg</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Intermountain Healthcare</name>
      <address>
        <city>Provo</city>
        <state>Utah</state>
        <zip>84604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Inova Alexandria Hospital</name>
      <address>
        <city>Alexandria</city>
        <state>Virginia</state>
        <zip>22304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brigitte Kelly</last_name>
      <phone>434-297-7136</phone>
      <email>bjk3c@virginia.edu</email>
    </contact>
    <investigator>
      <last_name>Daniel Sheeran, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luke Wilkins, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>James Stone, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Adiyta Sharma, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gundersen Health System</name>
      <address>
        <city>La Crosse</city>
        <state>Wisconsin</state>
        <zip>54601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Meyers</last_name>
      <phone>608-775-0238</phone>
      <email>srmeyers@gundersenhealth.org</email>
    </contact>
    <contact_backup>
      <last_name>Christine Roraff</last_name>
      <email>cmroraff@gundersenhealth.org</email>
    </contact_backup>
    <investigator>
      <last_name>Ezana Azene, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Todd Kowalski, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Clark Davis, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jonanthan Zlabek, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kurt Ziegelbein, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Irina Shaknovich, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Patrick Self, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Weil</last_name>
      <phone>414-805-2077</phone>
      <email>eweil@mcw.edu</email>
    </contact>
    <contact_backup>
      <last_name>Elizabeth Weseman</last_name>
      <email>eweseman@mcw.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Eric Hohenwalter, MD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>James Gosset, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kellie Brown, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Malinowski, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Parag Patel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Matthew Scheidt, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brandon Key, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>June 27, 2023</last_update_submitted>
  <last_update_submitted_qc>June 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>deep vein thrombosis</keyword>
  <keyword>superficial venous reflux</keyword>
  <keyword>blood clot</keyword>
  <keyword>post thrombotic syndrome</keyword>
  <keyword>iliac vein obstruction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>Venous Insufficiency</mesh_term>
    <mesh_term>Postthrombotic Syndrome</mesh_term>
    <mesh_term>Postphlebitic Syndrome</mesh_term>
    <mesh_term>Leg Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03250247
org study id: 201707130
nct id: NCT03250247
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to determine if the use of image-guided, endovascular therapy
      (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease
      severity and improve quality of life in patients with established disabling iliac-obstructive
      post thrombotic syndrome (DIO-PTS).
The rationale for performing the C-TRACT Trial is based upon:

        1. the debilitating life impact of DIO-PTS upon patients, as cited in the U.S. Surgeon
           General's 2008 Call to Action on DVT (95);

        2. the inability of existing therapies to prevent or alleviate most cases of DIO-PTS;

        3. the role of iliac vein obstruction and saphenous reflux in causing the severe
           manifestations of DIO-PTS;

        4. the ability of stent placement and endovenous ablation to eliminate obstruction and
           reflux, respectively, to reduce PTS severity, and to improve QOL in preliminary studies;

        5. the risks, costs, and uncertainties of this novel but invasive strategy;

        6. the lack of consensus on whether EVT should be used for DIO-PTS;

        7. the motivation of our established investigator team to answer this critical clinical
           question.

      We will determine if EVT should be routinely used to treat DIO-PTS. If so, this finding will
      fundamentally change DIO-PTS practice towards more frequent use of EVT. If EVT proves
      ineffective or unsafe, this finding will reduce or eliminate the use of potentially risky and
      expensive procedures.

      374 subjects with established DIO-PTS will be randomized in a 1:1 ratio to either EVT or
      No-EVT treatment groups. All participants will receive standard PTS therapy. Subjects will be
      enrolled over approximately 36 months in 20-40 U.S. Clinical Centers, and followed for 24
      months. The study will take approximately 6 years to complete.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is an NIH-funded, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Blinded Clinical assessments for PTS will be obtained at baseline (pre-randomization) and at the 6- month follow-up visits. Examining clinicians will complete PTS training to ensure accuracy across all Clinical Centers. The examiners for PTS must be blinded to the subjects' treatment allocation. Subjects will be reminded not reveal to clinic staff which therapy they received (EVT or No-EVT). Subjects should be examined in the afternoon (the later the better) to allow the symptoms and signs of PTS to manifest. The assessment is performed as follows:
The subject should be asked to rate the 5 symptoms on the Villalta PTS scale for each leg, record his/her ratings on the CRF.
The subject's legs should be unclothed and he/she should be seated facing the blinded clinician (nurse or physician).The 5 signs of PTS and VCSS measures will be recorded by the blinded clinician. Leg ulcers (if present) will be assessed and measured.
measure: PTS Severity
time frame: over 6 months follow-up
description: 374 patients with moderate to severe post thrombotic syndrome (PTS) and iliac vein obstruction will receive optimal PTS therapy. 50% of those patients will also receive endovenous therapy; modified antithrombotic therapy, including anti-platelet agent, iliac vein stenting, and endovenous ablation of refluxing saphenous veins if indicated. At 6 months post-randomization, venous clinical severity scores (VCSS) will be obtained and PTS severity will be evaluated.
arm group label: Endovascular Therapy - Intervention
arm group type: Experimental
description: All subjects (EVT and No-EVT Arms) will receive optimal PTS care. At each Clinical Center, this will be supervised by a physician experienced in managing PTS.
Subjects randomized to EVT will receive the following:
imaging-guided iliac vein stent placement, and
endovenous ablation of refluxing saphenous vein(s), if the patient has truncal reflux and is still symptomatic.
optimal PTS therapy: medical and compression, lifestyle interventions and venous ulcer care
arm group label: Non-Endovascular Therapy - Control
arm group type: No Intervention
description: All subjects will receive optimal PTS care as noted above.
intervention type: Device
intervention name: Stents
description: US-guided puncture of vein, fluoroscopic monitoring of catheter/guidewire manipulations, baseline venogram of CFV through infrarenal IVC.
Iliac vein should be pre-dilated to at least 12 mm. Bare, self-expanding stents made of elgiloy or nitinol legally marketed in the US for any indication and that are at least 12 mm in diameter should be used to recanalize the entire diseased segment of vein.
The use of devices > 14 mm is highly recommended for the iliac vein and dilated to at least 14 mm, unless compelling patient factors dictates dilatation to a smaller diameter.
Balloon angioplasty of inflow veins.
After successful iliac vein recanalization, patients who continue to be symptomatic beyond 2 weeks follow-up and who have valvular reflux in GSV, accessory GSV, anterolateral thigh circumflex, and/or SSV should be offered endovenous ablation.
Any FDA-approved method may be used including radiofrequency or laser ablation, sclerotherapy or pharmacomechanical ablation.
arm group label: Endovascular Therapy - Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suresh Vedantham, M.D.
role: Principal Investigator
affiliation: Clinical Coordinating Center at Washington University School of Medicine
last name: Mary Clare Derfler, RN MSN
phone: 314-973-0739
email: Derflerm@wustl.edu
last name: Patty Nieters, RN, BSN
phone: 314-362-3371
email: nietersp@wustl.edu
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country: United States
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Venous Thrombosis
mesh term: Varicose Ulcer
mesh term: Venous Insufficiency
mesh term: Postthrombotic Syndrome
mesh term: Postphlebitic Syndrome
mesh term: Leg Ulcer
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)