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NCT06394739Recruiting

RevCore for In Stent Thrombosis

Inari Medical

Start Date

9/9/2024

Completion Date

4/1/2028

Summary

The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Age ≥ 18 years 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: 1. Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel 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

Interventions

DEVICE

Thrombectomy

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Conditions

In-stent Thrombosis

Locations

Yale University

New Haven, Connecticut 06511

United States

Medstar Health Research Institute

Washington D.C., District of Columbia 20010

United States

St. Luke's Hospital Boise

Boise, Idaho 83712

United States

University of Maryland

Baltimore, Maryland 21201

United States

New York University- Langone

New York, New York 10016

United States

Mission Health

Asheville, North Carolina 28801

United States

UH Cleveland Medical Center

Cleveland, Ohio 44106

United States

Ohio State University

Columbus, Ohio 23210

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania 15212

United States

Spartanburg Medical Center

Spartanburg, South Carolina 29303

United States

El Paso Cardiology Associates

El Paso, Texas 79902

United States

Baylor Scott & White Research Institute

Plano, Texas 75093

United States

Sentara

Norfolk, Virginia 23507

United States

University of Washington

Seattle, Washington 98133

United States

West Virginia University- Ruby Memorial

Morgantown, West Virginia 26506

United States