RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECA… (NCT07219758) | Clinical Trial Compass
RecruitingNot Applicable
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)
United Kingdom30 participantsStarted 2025-10-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated informed consent form;
. Participant is 18 years of age and older;
. Neurologically stable;
. Ambulatory;
. Symptomatic chronic venous disease (CVD), with edema (CEAP classification of C3 or greater) or pain;
. 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
. Target treatment IVC/Common Iliac confluence to the deep veins above the knee.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Safety Endpoint - Rates of all Adverse Events through 30-days post-index procedure
Timeframe: 30-days post-procedure
2
Primary Efficacy Endpoint - Percent Lumen Gain in the Treated Vessel measured at time of procedure
. Comorbidity risks which may limit longevity (\<2 years life expectancy), would preclude open surgery, or would significantly increase risk for venous thrombo-embolism (VTE);
. Invasive abdominal, pelvic or peripheral vascular surgery within 90 days of the procedure;
. History of stroke within the last 6 months;
. Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period (i.e., known thrombophilia) including Heparin-induced thrombocytopenia (HIT) and antiphospholipid syndrome (APS);
. Interventional procedure in the deep venous system (including stent placement) in the target limb or outflow vessels within 6 weeks prior to consent;
. Acute deep venous thrombosis (DVT) in the index limb (not previously observed in the thrombus bearing segment) within 3 months prior to consent;
. Inadequate inflow in the opinion of the investigator, that cannot be improved to the target vessel;
. Flow-limiting venous outflow obstruction central to the target/treatment vessel that cannot be treated;