<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/NCT01692379</url>
  </required_header>
  <id_info>
    <org_study_id>REVASCAT</org_study_id>
    <nct_id>NCT01692379</nct_id>
  </id_info>
  <brief_title>Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours</brief_title>
  <acronym>REVASCAT</acronym>
  <official_title>RandomizEd Trial of reVascularizAtion With Solitaire FR® Device Versus Best mediCal Therapy in the Treatment of Acute Stroke Due to anTerior Circulation Large Vessel Occlusion Presenting Within 8 Hours of Symptom Onset</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio Ictus Malaltia Vascular</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacio Ictus Malaltia Vascular</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is&#xD;
      superior to medical management alone in achieving favorable outcome in the distribution of&#xD;
      the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel&#xD;
      ischemic stroke &lt; 8 hours from symptom onset.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a&#xD;
      sequential design. The randomization employs a 1:1 ratio of mechanical embolectomy with the&#xD;
      CE MARK approved stentriever Solitaire FR® versus medical management alone. Randomization&#xD;
      will be done under a minimization process using age, baseline NIHSS, therapeutic window and&#xD;
      vessel occlusion site. For the primary endpoint, subjects will be followed for 90 days&#xD;
      post-randomization.&#xD;
&#xD;
      Interim analysis will be performed as preplanned and interpreted by the Data Safety&#xD;
      Monitoring Board (DSMB) after the first 174, 346 and 518 patients representing 25%, 50% and&#xD;
      75% of the planned sample size have completed their 90-day follow-up. The DSMB will advise&#xD;
      the executive committee (EC) on recommendations to stop the trial early either for reasons of&#xD;
      safety, efficacy, futility or to adjust the sample size. The latter may be necessary as given&#xD;
      the paucity of data regarding natural history of the non-treated patients assumptions&#xD;
      regarding rates of favorable outcomes in this group of patients may be incorrect. Of note,&#xD;
      sample size adjustment based on different than expected outcomes rates is permitted, but it&#xD;
      is not permitted to adjust the sample size based on change in the pre-specified treatment&#xD;
      effect which is set at 10%.&#xD;
&#xD;
      Subject population: Subjects presenting with acute ischemic stroke within 8 hours from&#xD;
      symptom onset and whose strokes are attributable to an occlusion of the internal carotid or&#xD;
      proximal MCA (M1) arteries. Subjects are either ineligible for IV alteplase or have received&#xD;
      IV alteplase therapy without recanalization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Following DSMB advice after first interim analysis (n=174)&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis)</measure>
    <time_frame>90 days after enrollment</time_frame>
    <description>evaluated by two separate assessors who are blinded to treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality at 90 days</measure>
    <time_frame>90 days after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic Intracerebral Hemorrhage</measure>
    <time_frame>24h (-2/+12 hours) after enrollment</time_frame>
    <description>Deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans evaluated by independent CT/MR Core Lab and Clinical Events Committee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infarct Volume</measure>
    <time_frame>24h (-2/+12h) post treatment</time_frame>
    <description>Infarct volume evaluated in a second neuroimaging after treatment evaluated by independent CT/MR Core Lab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vessel recanalization</measure>
    <time_frame>24h post treatment</time_frame>
    <description>Vessel recanalization evaluated by CT angiography or MRA at 24 hours in both treatment groups evaluated by independent CT/MR Core Lab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraprocedural related complications in endovascular arm</measure>
    <time_frame>During endovascular treatment</time_frame>
    <description>Procedural related complications in the endovascular treatment arm: arterial perforation, arterial dissection, and embolization in a previously uninvolved vascular territory evaluated by the Angiography Core Lab and the Clinical Events Committee</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">206</enrollment>
  <condition>Acute Stroke</condition>
  <arm_group>
    <arm_group_label>Endovascular treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mechanical embolectomy with Solitaire FR device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medical treatment (standard of care in acute ischemic stroke)including intravenous thrombolysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Solitaire FR device</intervention_name>
    <description>Mechanical embolectomy in anterior large vessel occlusion</description>
    <arm_group_label>Endovascular treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical treatment</intervention_name>
    <description>Standard of care in acute ischemic stroke including intravenous rTPA</description>
    <arm_group_label>Medical treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or&#xD;
             the treatment is contraindicated (e.g., subject presents beyond recommended time from&#xD;
             symptom onset), or where patient has received IV thrombolytic therapy without&#xD;
             recanalization after a minimum of 30 min from start of iv tPA infusion&#xD;
&#xD;
          -  2. No significant pre-stroke functional disability (mRS ≤ 1)&#xD;
&#xD;
          -  3. Baseline NIHSS score obtained prior to randomization must be equal or higher than 6&#xD;
             points&#xD;
&#xD;
          -  4. Age ≥18 and ≤ 85.&#xD;
&#xD;
          -  5. Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions), MCA-M1&#xD;
             segment or tandem proximal ICA/MCA-M1 suitable for endovascular treatment, as&#xD;
             evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid&#xD;
             occlusion or stenosis&#xD;
&#xD;
          -  6. Patient treatable within eight hours of symptom onset. Symptoms onset is defined as&#xD;
             point in time the patient was last seen well (at baseline). Treatment start is defined&#xD;
             as groin puncture.&#xD;
&#xD;
          -  7. Informed consent obtained from patient or acceptable patient surrogate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical criteria&#xD;
&#xD;
          -  1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant&#xD;
             therapy with INR &gt; 3.0&#xD;
&#xD;
          -  2. Baseline platelet count &lt; 30.000/µL&#xD;
&#xD;
          -  3. Baseline blood glucose of &lt; 50mg/dL or &gt;400mg/dl&#xD;
&#xD;
          -  4. Severe, sustained hypertension (SBP &gt; 185 mm Hg or DBP &gt; 110 mm Hg)&#xD;
&#xD;
          -  5. Patients in coma (NIHSS item of consciousness &gt;1) (Intubated patients for transfer&#xD;
             could be randomized only in case an NIHSS is obtained by a neurologist prior&#xD;
             transportation).&#xD;
&#xD;
          -  6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS&#xD;
&#xD;
          -  7. Serious, advanced, or terminal illness with anticipated life expectancy of less&#xD;
             than one year.&#xD;
&#xD;
          -  8. History of life threatening allergy (more than rash) to contrast medium&#xD;
&#xD;
          -  9. Subjects who has received iv t-PA treatment beyond 4,5 hours from the beginning of&#xD;
             the symptoms&#xD;
&#xD;
          -  10. Renal insufficiency with creatinine ≥ 3 mg/dl&#xD;
&#xD;
          -  11. Woman of childbearing potential who is known to be pregnant or lactating or who&#xD;
             has a positive pregnancy test on admission.&#xD;
&#xD;
          -  12. Subject participating in a study involving an investigational drug or device that&#xD;
             would impact this study.&#xD;
&#xD;
          -  13. Cerebral vasculitis&#xD;
&#xD;
          -  14. Patients with a pre-existing neurological or psychiatric disease that would&#xD;
             confound the neurological or functional evaluations, mRS score at baseline must be ≤&#xD;
             1. This excludes patients who are severely demented, require constant assistance in a&#xD;
             nursing home type setting or who live at home but are not fully independent in&#xD;
             activities of daily living (toileting, dressing, eating, cooking and preparing meals,&#xD;
             etc.)&#xD;
&#xD;
          -  15. Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor&#xD;
             from overseas).&#xD;
&#xD;
        Neuroimaging criteria:&#xD;
&#xD;
          -  16. Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of &lt;7 on&#xD;
             NCCT or &lt;6 on DWI MRI. Patients 81 to 85 years old with ASPECTS score on non-contrast&#xD;
             CT or DWI MRI &lt;9 must be excluded. ASPECTS must be evaluated by CBV maps of CT&#xD;
             Perfusion, CTA source imaging (CTA-SI) or DWI-MR in patients whose vascular occlusion&#xD;
             study (CTA/MRA) confirming qualifying occlusion, is performed beyond 4.5 hours of last&#xD;
             seen well.&#xD;
&#xD;
          -  17. CT or MR evidence of hemorrhage (the presence of microbleeds is allowed).&#xD;
&#xD;
          -  18. Significant mass effect with midline shift.&#xD;
&#xD;
          -  19. Evidence of ipsilateral carotid occlusion, high grade stenosis or arterial&#xD;
             dissection in the extracranial or petrous segment of the internal carotid artery that&#xD;
             cannot be treated or will prevent access to the intracranial clot or excessive&#xD;
             tortuosity of cervical vessels precluding device delivery/deployment&#xD;
&#xD;
          -  20. Subjects with occlusions in multiple vascular territories (e.g., bilateral&#xD;
             anterior circulation, or anterior/posterior circulation)&#xD;
&#xD;
          -  21. Evidence of intracranial tumor (except small meningioma).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antoni Dávalos, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Universitario Germans Trias i Pujol, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tudor Jovin, MD</last_name>
    <role>Study Chair</role>
    <affiliation>UPMC Stroke Institute, Pittsburgh, PA, USA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angel Chamorro, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Clinic Barcelona, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joaquin Serena, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Josep Trueta, Girona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alex Rovira, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Vall D'Hebron, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maria A De Miquel, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital de Bellvitge, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luis Sanromán, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Clinic, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Erik Cobo, MD</last_name>
    <role>Study Director</role>
    <affiliation>UPC, Barcelona, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlos Molina, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Vall D'Hebron, Barcelona, Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Bellvitge</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall D'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://fundacioictus.com/</url>
    <description>Fundacio Ictus is a non-profit organization sponsoring REVASCAT study</description>
  </link>
  <reference>
    <citation>Molina CA, Chamorro A, Rovira A, de Miquel A, Serena J, Roman LS, Jovin TG, Davalos A, Cobo E. REVASCAT: a randomized trial of revascularization with SOLITAIRE FR device vs. best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within eight-hours of symptom onset. Int J Stroke. 2015 Jun;10(4):619-26. doi: 10.1111/ijs.12157. Epub 2013 Nov 10.</citation>
    <PMID>24206399</PMID>
  </reference>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>February 2, 2016</last_update_submitted>
  <last_update_submitted_qc>February 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute ischemic stroke</keyword>
  <keyword>endovascular treatment</keyword>
  <keyword>clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT01692379
org study id: REVASCAT
nct id: NCT01692379
lead sponsor: 
collaborator: 
has dmc: Yes
To evaluate the hypothesis that mechanical embolectomy with the Solitaire FR device is
      superior to medical management alone in achieving favorable outcome in the distribution of
      the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel
      ischemic stroke < 8 hours from symptom onset.
Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a
      sequential design. The randomization employs a 1:1 ratio of mechanical embolectomy with the
      CE MARK approved stentriever Solitaire FR® versus medical management alone. Randomization
      will be done under a minimization process using age, baseline NIHSS, therapeutic window and
      vessel occlusion site. For the primary endpoint, subjects will be followed for 90 days
      post-randomization.

      Interim analysis will be performed as preplanned and interpreted by the Data Safety
      Monitoring Board (DSMB) after the first 174, 346 and 518 patients representing 25%, 50% and
      75% of the planned sample size have completed their 90-day follow-up. The DSMB will advise
      the executive committee (EC) on recommendations to stop the trial early either for reasons of
      safety, efficacy, futility or to adjust the sample size. The latter may be necessary as given
      the paucity of data regarding natural history of the non-treated patients assumptions
      regarding rates of favorable outcomes in this group of patients may be incorrect. Of note,
      sample size adjustment based on different than expected outcomes rates is permitted, but it
      is not permitted to adjust the sample size based on change in the pre-specified treatment
      effect which is set at 10%.

      Subject population: Subjects presenting with acute ischemic stroke within 8 hours from
      symptom onset and whose strokes are attributable to an occlusion of the internal carotid or
      proximal MCA (M1) arteries. Subjects are either ineligible for IV alteplase or have received
      IV alteplase therapy without recanalization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis)
time frame: 90 days after enrollment
description: evaluated by two separate assessors who are blinded to treatment
measure: Mortality at 90 days
time frame: 90 days after enrollment
measure: Symptomatic Intracerebral Hemorrhage
time frame: 24h (-2/+12 hours) after enrollment
description: Deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans evaluated by independent CT/MR Core Lab and Clinical Events Committee
measure: Infarct Volume
time frame: 24h (-2/+12h) post treatment
description: Infarct volume evaluated in a second neuroimaging after treatment evaluated by independent CT/MR Core Lab
measure: Vessel recanalization
time frame: 24h post treatment
description: Vessel recanalization evaluated by CT angiography or MRA at 24 hours in both treatment groups evaluated by independent CT/MR Core Lab
measure: Intraprocedural related complications in endovascular arm
time frame: During endovascular treatment
description: Procedural related complications in the endovascular treatment arm: arterial perforation, arterial dissection, and embolization in a previously uninvolved vascular territory evaluated by the Angiography Core Lab and the Clinical Events Committee
arm group label: Endovascular treatment
arm group type: Experimental
description: Mechanical embolectomy with Solitaire FR device
arm group label: Medical treatment
arm group type: Active Comparator
description: Medical treatment (standard of care in acute ischemic stroke)including intravenous thrombolysis
intervention type: Device
intervention name: Solitaire FR device
description: Mechanical embolectomy in anterior large vessel occlusion
arm group label: Endovascular treatment
intervention type: Other
intervention name: Medical treatment
description: Standard of care in acute ischemic stroke including intravenous rTPA
arm group label: Medical treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Antoni Dávalos, MD
role: Study Chair
affiliation: Hospital Universitario Germans Trias i Pujol, Barcelona, Spain
last name: Tudor Jovin, MD
role: Study Chair
affiliation: UPMC Stroke Institute, Pittsburgh, PA, USA
last name: Angel Chamorro, MD
role: Study Director
affiliation: Hospital Clinic Barcelona, Barcelona, Spain
last name: Joaquin Serena, MD
role: Study Director
affiliation: Hospital Josep Trueta, Girona, Spain
last name: Alex Rovira, MD
role: Study Director
affiliation: Hospital Vall D'Hebron, Barcelona, Spain
last name: Maria A De Miquel, MD
role: Study Director
affiliation: Hospital de Bellvitge, Barcelona, Spain
last name: Luis Sanromán, MD
role: Study Director
affiliation: Hospital Clinic, Barcelona, Spain
last name: Erik Cobo, MD
role: Study Director
affiliation: UPC, Barcelona, Spain
last name: Carlos Molina, MD
role: Study Director
affiliation: Hospital Vall D'Hebron, Barcelona, Spain
facility: 
facility: 
facility: 
facility: 
country: Spain
url: http://fundacioictus.com/
description: Fundacio Ictus is a non-profit organization sponsoring REVASCAT study
citation: Molina CA, Chamorro A, Rovira A, de Miquel A, Serena J, Roman LS, Jovin TG, Davalos A, Cobo E. REVASCAT: a randomized trial of revascularization with SOLITAIRE FR device vs. best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within eight-hours of symptom onset. Int J Stroke. 2015 Jun;10(4):619-26. doi: 10.1111/ijs.12157. Epub 2013 Nov 10.
PMID: 24206399
responsible party type: Sponsor
mesh term: Stroke