Recana thrombectomy catheter for treating venous obstruction and occlusion

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

This study will try the Recana thrombectomy catheter to open blocked or narrowed veins in adults with symptomatic post-thrombotic venous obstruction.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Intervene, Inc. (Industry-sponsored)
• Locations: 1 site (London)
• Trial ID: NCT07219758 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomized, single-arm study that treats eligible adults with symptomatic post-thrombotic venous inflow/outflow obstruction using the Recana Thrombectomy Catheter System. The main safety endpoint is the rate of adverse events up to 30 days after the procedure, and the primary efficacy endpoint is achieving at least 50% lumen diameter by intravascular ultrasound during the index procedure. Participants are followed with duplex ultrasound, clinical assessments, quality-of-life measures, and adverse event monitoring at 30, 90, 180, and 365 days. Enrollment is expected to take 6–9 months with total follow-up of 12 months per participant.

Who should consider this trial

Good fit: Adults (≥18 years) who are ambulatory, neurologically stable, and have symptomatic chronic venous disease with flow-limiting venous outflow obstruction (CEAP C3 or greater) in the iliofemoral/IVC region are ideal candidates.

Not a fit: Patients with limited life expectancy, recent major abdominal/pelvic/peripheral vascular surgery, or other comorbidities that increase venous thromboembolism risk are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the device could restore venous flow and reduce symptoms such as edema and pain in patients with post-thrombotic venous obstruction.

How similar studies have performed: Mechanical thrombectomy and other endovenous treatments have shown benefit in selected patients with venous obstruction, but this specific Recana device is being newly studied in a dedicated prospective cohort.

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 disease (CVD), with edema (CEAP classification of C3 or greater) or pain;
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 prior to consent;
6. Acute deep venous thrombosis (DVT) in the index limb (not previously observed in the thrombus bearing segment) within 3 months prior to 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;
13. Patients considered to belong to a vulnerable population; and
14. Inability to secure venous access and cross lesion.

Where this trial is running

London

• St. Thomas' Hospital — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Stephen Black, MD — Guy's and St Thomas' NHS Foundation Trust
• Study coordinator: Clinical Affairs Team

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