Status:
RECRUITING
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-UK)
Lead Sponsor:
Intervene, Inc.
Conditions:
Venous Obstruction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 venou...
Detailed Description
STUDY DESIGN: The RECANA Study is a prospective, non-randomized, safety and performance (efficacy) study to evaluate participants treated with the Recana Thrombectomy Catheter System for the treatment...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form;
- Participant is 18 years of age and older;
- Neurologically stable;
- Ambulatory;
- Symptomatic chronic venous insuSciency (CVI), with edema or pain, (CEAP classification of C3 or greater);
- 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.
Exclusion
- 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 of consent;
- Acute deep venous thrombosis (DVT) in the index limb (not previously observed in the thrombus bearing segment) within 3 months of 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;
- Pregnant and/or breastfeeding;
- Patients with cognitive impairments who are unable to be consented;
- Patient is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results;
- COPD or similar conditions (lung cancer, pulmonary hypertension, prior major lung surgery, emphysema, O2 dependency) that may, in the opinion of the investigator result in higher pulmonary risk; and
- Patients considered to belong to a vulnerable population.
Key Trial Info
Start Date :
October 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07219758
Start Date
October 18 2025
End Date
July 1 2027
Last Update
October 22 2025
Active Locations (1)
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1
St. Thomas' Hospital
London, United Kingdom, SE1 7EH