Recana thrombectomy catheter for treating venous obstruction and occlusion

RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL)

This study will test whether the Recana Thrombectomy Catheter System can open blocked veins and relieve symptoms in adults with symptomatic post-thrombotic venous inflow/outflow obstruction.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Intervene, Inc. (industry)
• Locations: 1 site (Galway)
• Trial ID: NCT07095660 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomized safety and performance study of the Recana Thrombectomy Catheter System in patients with symptomatic post-thrombotic venous inflow/outflow obstruction. Qualified participants undergo a single index procedure using the Recana device, with immediate intravascular ultrasound (IVUS) measurement of percent lumen gain as the primary efficacy endpoint and recording of procedural adverse events through 30 days as the primary safety endpoint. Participants are followed through hospital discharge and at 30, 90, 180, and 365 days with duplex ultrasound, clinical assessments, quality-of-life measures, and adverse event monitoring. Enrollment is at least at University Hospital Galway and follow-up continues for 12 months after the procedure.

Who should consider this trial

Good fit: Adults aged 18 or older who are ambulatory with symptomatic chronic venous insufficiency (CEAP C3 or greater) and imaging-confirmed flow-limiting venous outflow obstruction (>50%) in the target iliofemoral/IVC region are the intended participants.

Not a fit: Patients with limited life expectancy (<2 years), recent invasive abdominal/pelvic/peripheral vascular surgery, or conditions that make them poor candidates for endovascular procedures may not receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the Recana device could reopen blocked veins, improve blood flow, and reduce pain and swelling for people with post-thrombotic venous obstruction.

How similar studies have performed: Catheter-based thrombectomy and endovenous recanalization approaches have shown success in restoring venous patency in prior work, but the Recana system is being newly evaluated in a prospective device-specific study.

Eligibility criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form;
2. Participant is 18 years of age and older;
3. Neurologically stable;
4. Ambulatory;
5. Symptomatic chronic venous insufficiency (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.

Exclusion Criteria:

1. Comorbidity risks which may limit longevity (\<2 years life expectancy), would preclude open surgery, or would significantly increase risk for venous thrombo-embolism (VTE);
2. Invasive abdominal, pelvic or peripheral vascular surgery within 90 days of the procedure;
3. History of stroke within the last 6 months;
4. 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);
5. Interventional procedure in the deep venous system (including stent placement) in the target limb or outflow vessels within 6 weeks of consent;
6. Acute deep venous thrombosis (DVT) in the index limb (not previously observed in the thrombus bearing segment) within 3 months of consent;
7. Inadequate inflow in the opinion of the investigator, that cannot be improved to the target vessel;
8. Flow-limiting venous outflow obstruction central to the target/treatment vessel that cannot be treated;
9. Pregnant and/or breastfeeding;
10. Patients with cognitive impairments who are unable to be consented;
11. Patient is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results;
12. 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
13. Patients considered to belong to a vulnerable population.

Where this trial is running

Galway

• University Hospital Galway — Galway, Ireland (RECRUITING)

Study contacts

• Principal investigator: Gerard O'Sullivan, MD — University Hospital Galway
• Study coordinator: Clinical Affairs

Conditions: Venous Obstruction, chronic venous disease, chronic venous insufficiency, CEAP classification of C3 or greater, flow-limiting venous outflow obstruction, post-thrombotic syndrome, venous inflow/outflow obstruction