NCT06394739 | Not yet recruiting | In-stent Thrombosis

Inari Medical

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

In-stent Thrombosis

Thrombectomy

Study Type :	Observational
Estimated Enrollment :	100 participants
Official Title :	RevCore for In Stent Thrombosis (REVIT)
Actual Study Start Date :	July 2024
Estimated Primary Completion Date :	December 2025
Estimated Study Completion Date :	December 2026

Information not available for Arms and Intervention/treatment

Inclusion Criteria

Age ≥ 18 years
Patients with stent age > 6 weeks
Location of thrombosed stents in proximal lower extremity deep vein segments including at least common femoral, external iliac, or common iliac vein
RevCore Thrombectomy Catheter must enter vasculature
Willing and able to provide informed consent

Exclusion Criteria

Exposed stents with broken struts, significantly deformed struts, struts protruding into the vessel
Stents not wall apposed
Stents compressed to <10mm
Bilateral in-stent thrombosis
Congenital anatomic anomalies of the iliac veins
Allergy, hypersensitivity, or thrombocytopenia from heparin or iodinated contrast agents, except for mild to moderate contrast allergies for which pretreatment can be used
Any contraindication to anticoagulants or antiplatelets that, in the opinion of the Investigator, cannot be medically managed throughout the study period
Chronic non-ambulatory status
Known hypercoagulable states (e.g. antiphospholipid syndrome) that, in the opinion of the Investigator, cannot be medically managed throughout the study period
Inability to secure venous access
Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
Current participation in another investigational drug or device treatment study

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.