RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)
Condition(s) studied
Investigational drug(s) / intervention(s)
Recana Thrombectomy Catheter System: recanalization and debulking of obstructions and occlusions within stented and non-stented segments in veins
Study summary
The goal of this clinical investigation is to learn if the Recana Thrombectomy Catheter System can treat chronic venous obstruction and occlusion in participants with symptomatic post-thrombotic venous inflow/outflow obstruction. The main questions the clinical investigation aims to answer are:
1. primary safety endpoint: procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure
2. primary efficacy endpoint: greater than or equal to 50 percent (%) lumen diameter achieved during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative/periprocedural)
Participants are screened and qualified for the clinical investigation. Qualifed participants (those that meet all eligibility criteria) will undergo treatment with the Recana Thrombectomy Catheter System. Participants are assessed at the following timepoints: 30, 90, 180 and 365 days post-procedure.
Eligibility
Primary outcome measure(s)
- Primary Safety Endpoint - Rates of all Adverse Events through 30-days post-index procedure — 30-days post-procedure
The primary safety objective is procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure - Primary Efficacy Endpoint - Percent Lumen Gain in the Treated Vessel measured at time of procedure — Perioperative/Periprocedural
The primary efficacy assessment is greater than or equal to 50 percent (%) lumen diameter achieved during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative/periprocedural)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| St. Thomas' Hospital | London | United Kingdom | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07219758 on ClinicalTrials.gov ↗ ← All trials in the UK