RevCore for In Stent Thrombosis (REVIT)

Inari Medical

Status: Enrolling

Conditions: In-stent Thrombosis

Treatments: Device: Thrombectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT06394739

23-002 REVIT

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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