Recruiting

RevCore

Sponsor:

Inari Medical

Code:

NCT06394739

Conditions

In-stent Thrombosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thrombectomy

Study Details

Brief summary:

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

Conditions

In-stent Thrombosis

Study ID

NCT06394739

Start date

Sep 9, 2024

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

Thrombectomy

RevCore Thrombectomy to treat in-stent thrombosis

Primary outcome measure

  • Evidence of successful stent recanalization [ Time Frame: Immediately after the RevCore thrombectomy procedure for in-stent thrombosis ]

Central Contacts and Locations

Central contacts

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Principal Investigator:

Angelo Marino, OD

Medstar Health Research Institute

Recruiting

Washington D.C., District of Columbia, United States, 20010

Principal Investigator:

Kyle Reynolds, MD

St. Luke's Hospital Boise

Recruiting

Boise, Idaho, United States, 83712

Principal Investigator:

Tyler Harris, MD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Khanjan Nagarsheth, MD

New York University- Langone

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Mikel Sadek, MD

Mission Health

Recruiting

Asheville, North Carolina, United States, 28801

Principal Investigator:

Trevor Downing, MD

UH Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Karem Harth, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 23210

Principal Investigator:

Mina Makary, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Ryan Cobb, MD

Allegheny Health Network Research Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Principal Investigator:

Abdullah Shaikh, MD

Spartanburg Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Principal Investigator:

Brian Brown, MD

El Paso Cardiology Associates

Recruiting

El Paso, Texas, United States, 79902

Principal Investigator:

Waseem Shami, MD

Baylor Scott & White Research Institute

Recruiting

Plano, Texas, United States, 75093

Sentara

Recruiting

Norfolk, Virginia, United States, 23507

Principal Investigator:

David Dexter, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98133

Principal Investigator:

Jake Hemingway, MD

West Virginia University- Ruby Memorial

Recruiting

Morgantown, West Virginia, United States, 26506

Principal Investigator:

Robert Grammer, MD

More Information

Sponsor

Inari Medical

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Inari Medical on 2026-08-11.