Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07219758

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 Sites

88 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: greater than or equal to 50 percent (%) lumen diameter achieved 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. Qualifed 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-UK)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 (CEAP class C3 or greater) or pain
  • Flow-limiting venous outflow obstruction greater than 50% at target sites as defined by duplex ultrasound or imaging
  • Target treatment area from IVC/Common Iliac confluence to deep veins above the knee
Not Eligible

You will not qualify if you...

  • Life expectancy less than 2 years or conditions precluding surgery or increasing venous thromboembolism risk
  • Invasive abdominal, pelvic, or peripheral vascular surgery within 90 days before procedure
  • History of stroke within last 6 months
  • Known hypercoagulable states that cannot be medically managed during study
  • Interventional procedure in deep venous system of target limb within 6 weeks before consent
  • Acute deep venous thrombosis in index limb within 3 months before consent
  • Inadequate inflow that cannot be improved to target vessel
  • Untreatable flow-limiting venous outflow obstruction central to target vessel
  • Pregnant or breastfeeding
  • Cognitive impairments preventing informed consent
  • Enrollment in conflicting clinical study
  • COPD or similar lung conditions that increase pulmonary risk
  • Vulnerable populations
  • Inability to secure venous access and cross lesion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Thomas' Hospital

London, United Kingdom, SE1 7EH

Actively Recruiting

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Research Team

C

Clinical Affairs Team

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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