RevCore (1920 x 640 px)

REVIT Study

A real-world, multicenter, prospective registry of RevCore for the treatment of in-stent thrombosis

NCT06394739

Design

Global Co-PIs: Karem Harth, MD & Ronald Winokur, MD

Steering Committee: Steven Abramowitz, MD, Ryan Cobb, MD, Michael Lichtenberg, MD, Abdullah Shaikh, MD

Objective-icons

Objective

  • The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages
Design-icons

Design

Observational model: Cohort

  • 100 patients | Up to 30 US sites
  • Patients with a thrombosed venous stent placed >6 weeks before enrollment
CLOUT-Key Eligibility Criteria-icons.png

Key eligibility criteria

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
Primary-endpoint-icons

Primary effectiveness endpoint

  • Successful stent recanalization (defined as patency ≥50% luminal diameter), assessed post-procedure using intravascular ultrasound
FLASH-Secondary Endpoints and Clinical Outcomes-icon-centered

Key secondary endpoints

CEC-adjudicated, 30-day SAEs (e.g., mortality, clinically significant PE, vessel perforation, stent fracture/migration, rethrombosis)

Duration-of-patient-follow-up

Duration of patient follow-up

Imaging at 30-day, 6-month, and 1-year

  • Presence of flow
  • Recanalization of patency
Key-eligibility-criteria-icons

Clinical outcomes at 30-day, 6-month, and 1-year

  • Clinical-Etiology-Anatomy-Pathophysiology (CEAP) score
  • Villalta score
  • Quality of life with EQ-5D-5L