RevCore for in Stent Thrombosis

Recruiting

• Conditions: In-stent Thrombosis

• Registration Number: NCT06394739
• Lead Sponsor: Inari Medical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-01
• Study Start: 2024-09-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evidence of successful stent recanalization	Immediately after the RevCore thrombectomy procedure for in-stent thrombosis	Defined as patency ≥50% luminal diameter utilizing intravascular ultrasound (IVUS)

Trial Locations

Locations (10)

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Medstar Health Research Institute; 🇺🇸 Washington, District of Columbia, United States

Mission Health Hospital; 🇺🇸 Asheville, North Carolina, United States

UH Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Allegheny Health Network Research Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

Spartanburg Medical Center; 🇺🇸 Spartanburg, South Carolina, United States

El Paso Cardiology Associates; 🇺🇸 El Paso, Texas, United States