RevCore for In Stent Thrombosis

Description

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 Overview

Study Details

Study overview

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

RevCore for In Stent Thrombosis (REVIT)

RevCore for In Stent Thrombosis

Condition
In-stent Thrombosis
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, New Haven, Connecticut, United States, 06511

Washington

Medstar Health Research Institute, Washington, District of Columbia, United States, 20010

Asheville

Mission Health Hospital, Asheville, North Carolina, United States, 28801

Cleveland

UH Cleveland Medical Center, Cleveland, Ohio, United States, 44106

Pittsburgh

Allegheny Health Network Research Institute, Pittsburgh, Pennsylvania, United States, 15212

El Paso

El Paso Cardiology Associates, El Paso, Texas, United States, 79902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Inari Medical,

Study Record Dates

2026-12