RevCore for In Stent Thrombosis

Last updated: June 27, 2025
Sponsor: Inari Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Treatment

Thrombectomy

Clinical Study ID

NCT06394739
23-002 REVIT
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Patients with stent age > 6 weeks

  3. Location of thrombosed stents in proximal lower extremity deep vein segmentsincluding 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

Exclusion Criteria:

  1. Exposed stents with broken struts, significantly deformed struts, struts protrudinginto 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 contrastagents, except for mild to moderate contrast allergies for which pretreatment can beused

  7. Any contraindication to anticoagulants or antiplatelets that, in the opinion of theInvestigator, cannot be medically managed throughout the study period

  8. Chronic non-ambulatory status

  9. Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinionof 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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Thrombectomy
Phase:
Study Start date:
September 09, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Yale University

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

  • Medstar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • New York University- Langone

    New York, New York 10016
    United States

    Active - Recruiting

  • Mission Health Hospital

    Asheville, North Carolina 28801
    United States

    Active - Recruiting

  • UH Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 23210
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Allegheny Health Network Research Institute

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Spartanburg Medical Center

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • El Paso Cardiology Associates

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • West Virginia University- Ruby Memorial

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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