- RECANA OUS – Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK) — Recruiting • Non-phase study • Respiratory / COPD / Asthma • NCT07219758.
- 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….
- Sponsor: Intervene, Inc.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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: percent (%) lumen gain during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative/periprocedural) Participants are screened…
- : 1. Provision of signed and dated informed consent form;
- Participant is 18 years of age and older; 3. Neurologically stable; 4. Ambulatory; 5. Symptomatic chronic venous insuSciency (CVI), with edema or pain, (CEAP classification of C3 or greater); 6. Flow-limiting venous outflow obstruction (>50%) within the intended target sites, defined by (a) a common femoral vein continuous waveform without respiratory variation on duplex ultrasound, or, (b) complete occlusion of any part of the iliofemoral tract as diagnosed on baseline duplex or axial imaging per local protocol; and 7. Target treatment IVC/Common Iliac confluence to the deep veins above the knee.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.