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RECANA OUS - Recana Thrombectomy Catheter System For Venous Obstruction And Occlusion Study RECANA-OUS-UK
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Actively Recruiting
Phase Not Applicable
Age: 18 Years +
All Genders
ID: 07219758
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)
Led by Intervene, Inc.
Updated on 2026-05-06
30 Participants Needed
1 Research Site
N/A Total Duration
On this page
- AI-Summary
- Brief Title
- Who Can Participate
- AI-Screening
- Your Study Journey
- Trial Site Locations
- Research Team
- How is the study designed?
- Similar Trials
- Frequently Asked Questions
AI-Summary
What This Trial Is About
Researchers are evaluating the Recana Thrombectomy Catheter System to treat chronic venous obstruction and occlusion in people with symptomatic post-thrombotic venous inflow or outflow obstruction. This prospective, non-randomized study aims to assess the safety and performance of the device. The main questions are to understand the rates of adverse events within 30 days after the procedure and to measure if the treated vein achieves at least 50% opening during the procedure, using intravascular ultrasound. Participants who qualify will receive treatment with the Recana Thrombectomy Catheter System, which is designed to reopen and clear blockages in veins, both with and without stents. After the initial treatment procedure, participants will be followed and assessed at 30, 90, 180, and 365 days. The study includes clinical assessments, duplex ultrasound imaging, quality of life evaluations, monitoring of adverse events, and recording of any medications taken. Participants will be screened and evaluated before treatment to confirm eligibility. Safety and treatment effects are monitored closely from the day of the procedure through one year afterward. Follow-up visits include ultrasound scans and clinical exams to measure vein opening and check for any complications. The study aims to enroll patients over about 6 to 9 months, with total participation lasting around 18 to 21 months including follow-up.
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CONDITIONS
Brief Title
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)
Who Can Participate
Age: 18 Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Age 18 years or older
- Neurologically stable
- Able to walk (ambulatory)
- Symptomatic chronic venous disease with edema or pain (CEAP classification C3 or higher)
- Flow-limiting venous outflow obstruction (>50%) in target sites as defined by ultrasound or imaging
- Target area for treatment from IVC/Common Iliac confluence to deep veins above the knee
You will not qualify if you...
- Limited life expectancy less than 2 years or comorbidities that increase risk
- Invasive abdominal, pelvic, or peripheral vascular surgery within 90 days before procedure
- Stroke within the last 6 months
- Known hypercoagulable conditions that cannot be managed, including Heparin-induced thrombocytopenia and antiphospholipid syndrome
- Interventional procedure in the deep venous system within 6 weeks prior to consent
- Acute deep venous thrombosis in the limb within 3 months prior to consent
- Inadequate inflow or untreatable flow-limiting obstruction central to target vessel
- Pregnant or breastfeeding
- Cognitive impairments preventing consent
- Enrolled in another conflicting clinical study
- COPD or similar lung conditions increasing pulmonary risk
- Vulnerable populations
- Inability to access veins or cross lesion for treatment
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
- 1 visit (in-person) for informed consent and eligibility assessments
Implementation
Duration - Day of the index procedure through hospital discharge
Participants undergo the index procedure where the Recana Thrombectomy Catheter System is used to treat symptomatic post-thrombotic venous inflow/outflow obstruction.
- 1 visit for the procedure and hospital stay
Follow-up
Duration - 365 days post-procedure
Participants are monitored for safety and efficacy through clinical assessments, duplex ultrasound, quality of life evaluations, and adverse event tracking.
- Visits at 30, 90, 180, and 365 days post-procedure
Trial Site Locations
Total: 1 location
St. Thomas' Hospital
London, United Kingdom, SE1 7EH
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Research Team
Clinical Affairs Team
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How is the study designed?
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Frequently Asked Questions
Sponsors
Intervene, Inc.
Lead Sponsor
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