Actively Recruiting
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)
Led by Intervene, Inc. · Updated on 2025-10-22
20
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- 18 years of age or older
- Neurologically stable
- Ambulatory
- Symptomatic chronic venous insufficiency with edema or pain, CEAP classification of C3 or greater
- Flow-limiting venous outflow obstruction greater than 50% within target sites as diagnosed by duplex ultrasound or imaging
- Target treatment from IVC/Common Iliac confluence to deep veins above the knee
You will not qualify if you...
- Comorbidities limiting life expectancy to less than 2 years or increasing risk for venous thromboembolism
- Invasive abdominal, pelvic, or peripheral vascular surgery within 90 days prior to procedure
- History of stroke within the last 6 months
- Known hypercoagulable states not medically manageable during the study (including HIT and APS)
- Interventional procedure in the deep venous system of target limb within 6 weeks prior to consent
- Acute deep venous thrombosis in the index limb within 3 months prior to consent
- Inadequate inflow that cannot be improved to target vessel
- Untreatable flow-limiting venous outflow obstruction central to target vessel
- Pregnant or breastfeeding
- Cognitive impairment preventing consent
- Enrollment in another conflicting clinical study
- COPD or related lung conditions increasing pulmonary risk
- Considered part of a vulnerable population
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Galway
Galway, Ireland
Actively Recruiting
Research Team
C
Clinical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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