<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/NCT03791970</url>
  </required_header>
  <id_info>
    <org_study_id>AAL02</org_study_id>
    <nct_id>NCT03791970</nct_id>
  </id_info>
  <brief_title>Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries</brief_title>
  <acronym>SFA</acronym>
  <official_title>A Prospective, Single Center, Case-cohort Study Using the Orchid Drug Coated Balloon for Post-Dilatation of the Stent for Treatment of Long Lesions in Femoropopliteal Arteries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the efficacy and safety of stent angioplasty with Orchid 035 Drug Coated&#xD;
      Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long&#xD;
      (&gt;10cm) femoropopliteal chronic total occlusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Prospective, Single Center, Case-cohort Study Using the Orchid Drug Coated Balloon for&#xD;
      Post-Dilatation of the Stent for Treatment of Long Lesions in Femoropopliteal Arteries.&#xD;
&#xD;
      Patients will be selected based on the investigator's assessment, evaluation of the&#xD;
      underlying disease and the eligibility criteria. The patient's medical condition should be&#xD;
      stable, with no underlying medical condition which would prevent them from performing the&#xD;
      required testing or from completing the study. Patients should also be geographically stable,&#xD;
      willing and able to cooperate in this clinical study and remain available for long-term&#xD;
      follow-up. A patient is considered enrolled in the study after obtaining the patients&#xD;
      informed consent, if there is full compliance with the study eligibility criteria and after&#xD;
      successful stent angioplasty for the occluded femoropopliteal arteries.&#xD;
&#xD;
      Prior to the index procedure the following tests and clinical data will be collected:&#xD;
      informed consent for data collection, demographics, medical history, medication record,&#xD;
      physical examination, clinical category of chronic limb ischemia (Rutherford category) and&#xD;
      resting ankle-brachial index (ABI).&#xD;
&#xD;
      During the procedure, the vascular access can be achieved to the investigator's standard&#xD;
      clinical practice. After successful lesion passage, diagnostic angiography of the lesion area&#xD;
      and distal run-off is performed and angiographic measurements (vessel diameter, percentage&#xD;
      stenosis and lesion length) are collected. All inflow-limiting lesion will be treated&#xD;
      according to the investigators standard clinical practice before treatment of the target&#xD;
      lesion. The study compares the efficacy and safety of stent angioplasty with Orchid 035 Drug&#xD;
      Coated Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long&#xD;
      (&gt;10cm) femoropopliteal chronic total occlusion. The indication for stent placement is based&#xD;
      on the investigator's assessment. An expected total of 180 patients will be treated in the&#xD;
      scope of this study. The lesion is located within the native superficial femoral artery&#xD;
      and/or the popliteal artery. Prior to stents placement, pre-dilatation with the POBA balloon&#xD;
      is mandatory. After stents placement, post-dilatation with the Orchid 035 DCB or POBA need to&#xD;
      be performed. Patients will be invited for a follow-up visit at 1, 6 and 12 month&#xD;
      post-procedure. The primary efficacy endpoint of the study is defined as the freedom from&#xD;
      clinically-driven target lesion revascularization (TLR) at 12 months. Secondary endpoints&#xD;
      include primary patency rate at 6 and 12 months, freedom from clinically-driven TLR at 6&#xD;
      months, clinical success at 1, 6 and 12 months and freedom from serious adverse events at&#xD;
      pre-discharge, 1, 6 and 12 months follow-up.No other adjunctive therapies (atherectomy,&#xD;
      laser) are allowed. The complete femoropopliteal vasculature should be treated in one single&#xD;
      session, staged interventions are not allowed. All outflow-limiting lesions must be treated&#xD;
      according to the hospital treatment standard.&#xD;
&#xD;
      The regular follow-ups are necessary to monitor the condition of the patient and the&#xD;
      procedure. Patients will be invited for a follow-up visit at 1, 6 and 12 months after the&#xD;
      index procedure. The following data will be collected during these follow-up visit:&#xD;
      medication record, physical examination, rutherford categorization, ABI and color flow&#xD;
      doppler ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary patency rate</measure>
    <time_frame>12 months post-procedure</time_frame>
    <description>Absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.5) at the target lesion and without TLR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from clinically-driven TLR</measure>
    <time_frame>6 and 12 months post-procedure</time_frame>
    <description>TLR defined as a repeated intervention to maintain or re-establish patency within the region of the treated arteries</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Peripheral Artery Disease</condition>
  <arm_group>
    <arm_group_label>DCB for post-dilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DCB was used for post-dilation after stent placement. The DCB for post-dilation in this study is Orchid 035 DCB Catheter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>POBA for post-dilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>POBA was used for post-dilation after stent placement. POBA Catheter for post-dilation in this study can be Mustang, Dorado or others balloon catheters.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Orchid 035 DCB Catheter</intervention_name>
    <description>Stents placement for femoropopliteal arterial occlusions following with Orchid 035 DCB Catheter for post-dilation</description>
    <arm_group_label>DCB for post-dilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>POBA Catheter</intervention_name>
    <description>Stents placement for femoropopliteal arterial occlusions following with POBA for post-dilation</description>
    <arm_group_label>POBA for post-dilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years;&#xD;
&#xD;
          2. The subject is legally competent and able to understand the information on the study,&#xD;
             has been informed of the nature, the scope and the relevance of the study, voluntarily&#xD;
             agrees to participation and the study's provisions, and has duly signed the Informed&#xD;
             Consent Form (ICF);&#xD;
&#xD;
          3. Rutherford Category 2-4;&#xD;
&#xD;
          4. Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence&#xD;
             of long-term occlusion (by visual estimate ≥10cm) and is amenable to treatment with&#xD;
             stents placement;&#xD;
&#xD;
          5. Patients must be able to be treated with DCB or POBA for post-dilation;&#xD;
&#xD;
          6. Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be&#xD;
             treated with available device size matrix;&#xD;
&#xD;
          7. At least one patent native outflow artery to the ankle free from significant lesion&#xD;
             (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT&#xD;
             permitted; treatment of in-flow disease is permitted prior to treatment with stents&#xD;
             placement).&#xD;
&#xD;
          8. No other prior vascular interventions (including contralateral limb) within 2 weeks&#xD;
             before and/or planned 30 days after the protocol treatment, with the exception of&#xD;
             remote common femoral patch angioplasty separated by at least 2 cm from the target&#xD;
             lesion;&#xD;
&#xD;
          9. Female subjects of childbearing potential have a negative urine or serum pregnancy&#xD;
             test within 7 days prior to index procedure;&#xD;
&#xD;
         10. Lesion location starts ≥1 cm below the common femoral bifurcation and P1 popliteal&#xD;
             artery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant, lactating, or planning on becoming pregnant or men intending to father&#xD;
             children;&#xD;
&#xD;
          2. Contraindication to stent or DCB or POBA per current information for use (IFU);&#xD;
&#xD;
          3. Life expectancy of &lt;1 year;&#xD;
&#xD;
          4. Inability to take required antiplatelet/anticoagulant medications, or known&#xD;
             contraindication (including allergic reaction) or sensitivity to contrast media,&#xD;
             nickel, titanium or tantalum that cannot be adequately managed with pre- and&#xD;
             post-procedure medication;&#xD;
&#xD;
          5. Intended treatment of outflow disease during the index procedure;&#xD;
&#xD;
          6. Intended use of laser, atherectomy or cryoplasty during index procedure;&#xD;
&#xD;
          7. Sudden symptom onset, acute vessel occlusion, or acute or subacute thrombus in target&#xD;
             vessel;&#xD;
&#xD;
          8. History of stroke within 3 months;&#xD;
&#xD;
          9. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;&#xD;
&#xD;
         10. Participation in an investigational drug or another investigational device study until&#xD;
             this study's primary endpoint is reached or previous enrollment in this study;&#xD;
&#xD;
         11. Another medical condition, which, in the opinion of the Investigator, may cause the&#xD;
             patient to be noncompliant with the Concern/Information Need/Participation Willingness&#xD;
             (CIP) or confound data interpretation;&#xD;
&#xD;
         12. Target vessel and/or lesion involves a previously placed stent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xinwu Lu, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kai'chuang Ye, MD, PhD</last_name>
    <phone>+86 021-23271699-5591</phone>
    <email>ykaichuang@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xinrui Yang, MD, PhD</last_name>
    <phone>+86 021-23271699-5591</phone>
    <email>cinder_13@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kaichuang Ye</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kaichuang Ye, MD, PhD</last_name>
      <phone>+86 13761140452</phone>
      <email>ykaichuang@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Minyi Yin</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Minyi Yin, MD,PHD</last_name>
      <phone>021-23271699-5591</phone>
      <email>ykaichuang@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Kaichuang Ye, MD,PHD</last_name>
      <phone>021-23271699-5591</phone>
      <email>ykaichuang@163.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Xiaobing Liu</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaobing Liu, MD,PHD</last_name>
      <phone>021-23271699-5199</phone>
      <email>benny_liuxb@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Kaichuang Ye, MD,PHD</last_name>
      <phone>021-23271699-5591</phone>
      <email>ykaichuang@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</investigator_affiliation>
    <investigator_full_name>Kaichuang Ye, MD, PhD</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03791970
org study id: AAL02
nct id: NCT03791970
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To compare the efficacy and safety of stent angioplasty with Orchid 035 Drug Coated
      Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long
      (>10cm) femoropopliteal chronic total occlusion.
A Prospective, Single Center, Case-cohort Study Using the Orchid Drug Coated Balloon for
      Post-Dilatation of the Stent for Treatment of Long Lesions in Femoropopliteal Arteries.

      Patients will be selected based on the investigator's assessment, evaluation of the
      underlying disease and the eligibility criteria. The patient's medical condition should be
      stable, with no underlying medical condition which would prevent them from performing the
      required testing or from completing the study. Patients should also be geographically stable,
      willing and able to cooperate in this clinical study and remain available for long-term
      follow-up. A patient is considered enrolled in the study after obtaining the patients
      informed consent, if there is full compliance with the study eligibility criteria and after
      successful stent angioplasty for the occluded femoropopliteal arteries.

      Prior to the index procedure the following tests and clinical data will be collected:
      informed consent for data collection, demographics, medical history, medication record,
      physical examination, clinical category of chronic limb ischemia (Rutherford category) and
      resting ankle-brachial index (ABI).

      During the procedure, the vascular access can be achieved to the investigator's standard
      clinical practice. After successful lesion passage, diagnostic angiography of the lesion area
      and distal run-off is performed and angiographic measurements (vessel diameter, percentage
      stenosis and lesion length) are collected. All inflow-limiting lesion will be treated
      according to the investigators standard clinical practice before treatment of the target
      lesion. The study compares the efficacy and safety of stent angioplasty with Orchid 035 Drug
      Coated Dilatation (DCB) and Plain Old Balloon Angioplasty (POBA) for post-dilatation for long
      (>10cm) femoropopliteal chronic total occlusion. The indication for stent placement is based
      on the investigator's assessment. An expected total of 180 patients will be treated in the
      scope of this study. The lesion is located within the native superficial femoral artery
      and/or the popliteal artery. Prior to stents placement, pre-dilatation with the POBA balloon
      is mandatory. After stents placement, post-dilatation with the Orchid 035 DCB or POBA need to
      be performed. Patients will be invited for a follow-up visit at 1, 6 and 12 month
      post-procedure. The primary efficacy endpoint of the study is defined as the freedom from
      clinically-driven target lesion revascularization (TLR) at 12 months. Secondary endpoints
      include primary patency rate at 6 and 12 months, freedom from clinically-driven TLR at 6
      months, clinical success at 1, 6 and 12 months and freedom from serious adverse events at
      pre-discharge, 1, 6 and 12 months follow-up.No other adjunctive therapies (atherectomy,
      laser) are allowed. The complete femoropopliteal vasculature should be treated in one single
      session, staged interventions are not allowed. All outflow-limiting lesions must be treated
      according to the hospital treatment standard.

      The regular follow-ups are necessary to monitor the condition of the patient and the
      procedure. Patients will be invited for a follow-up visit at 1, 6 and 12 months after the
      index procedure. The following data will be collected during these follow-up visit:
      medication record, physical examination, rutherford categorization, ABI and color flow
      doppler ultrasound.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Primary patency rate
time frame: 12 months post-procedure
description: Absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.5) at the target lesion and without TLR
measure: Freedom from clinically-driven TLR
time frame: 6 and 12 months post-procedure
description: TLR defined as a repeated intervention to maintain or re-establish patency within the region of the treated arteries
arm group label: DCB for post-dilation
arm group type: Experimental
description: DCB was used for post-dilation after stent placement. The DCB for post-dilation in this study is Orchid 035 DCB Catheter.
arm group label: POBA for post-dilation
arm group type: Active Comparator
description: POBA was used for post-dilation after stent placement. POBA Catheter for post-dilation in this study can be Mustang, Dorado or others balloon catheters.
intervention type: Device
intervention name: Orchid 035 DCB Catheter
description: Stents placement for femoropopliteal arterial occlusions following with Orchid 035 DCB Catheter for post-dilation
arm group label: DCB for post-dilation
intervention type: Device
intervention name: POBA Catheter
description: Stents placement for femoropopliteal arterial occlusions following with POBA for post-dilation
arm group label: POBA for post-dilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xinwu Lu, MD, PhD
role: Study Chair
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
last name: Kai'chuang Ye, MD, PhD
phone: +86 021-23271699-5591
email: ykaichuang@163.com
last name: Xinrui Yang, MD, PhD
phone: +86 021-23271699-5591
email: cinder_13@126.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
investigator full name: Kaichuang Ye, MD, PhD
investigator title: Clinical Professor
mesh term: Peripheral Arterial Disease
sharing ipd: No