RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)

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 postthrombotic 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: patency 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. Qualified 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.

NCT Number	NCT07095660
Lead Sponsor	Intervene, Inc.
Conditions	Venous Obstruction
Enrollment	20 participants
Start Date	2025-07-02
Primary Completion	2027-04-30 (estimated)
Study Completion	2027-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-27