Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-09-09
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Thrombectomy
RevCore Thrombectomy to treat in-stent thrombosis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with stent age \> 6 weeks
3. Location of thrombosed stents in proximal lower extremity deep vein segments including at least common femoral, external iliac, or common iliac vein
4. RevCore Thrombectomy Catheter must enter vasculature
5. Willing and able to provide informed consent
Exclusion Criteria
2. Stents not wall apposed
3. Stents compressed to \<10mm
4. Bilateral in-stent thrombosis
5. Congenital anatomic anomalies of the iliac veins
6. Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
7. Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
8. Chronic non-ambulatory status
9. Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinion of the Investigator, cannot be medically managed throughout the study period
10. Inability to secure venous access
11. Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
12. Current participation in another investigational drug or device treatment study
18 Years
ALL
No
Sponsors
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Inari Medical
INDUSTRY
Responsible Party
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Locations
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Yale University
New Haven, Connecticut, United States
Medstar Health Research Institute
Washington D.C., District of Columbia, United States
University of Maryland
Baltimore, Maryland, United States
New York University- Langone
New York, New York, United States
Mission Health
Asheville, North Carolina, United States
UH Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
El Paso Cardiology Associates
El Paso, Texas, United States
Sentara
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
West Virginia University- Ruby Memorial
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Angelo Marino, OD
Role: primary
Kyle Reynolds, MD
Role: primary
Khanjan Nagarsheth, MD
Role: primary
Mikel Sadek, MD
Role: primary
Trevor Downing, MD
Role: primary
Karem Harth, MD
Role: primary
Mina Makary, MD
Role: primary
Ryan Cobb, MD
Role: primary
Robert Ford, MD
Role: primary
Abdullah Shaikh, MD
Role: primary
Brian Brown, MD
Role: primary
Waseem Shami, MD
Role: primary
David Dexter, MD
Role: primary
Jake Hemingway, MD
Role: primary
Robert Grammer, MD
Role: primary
Other Identifiers
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23-002 REVIT
Identifier Type: -
Identifier Source: org_study_id