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

NCT07095660 | Recruiting DMC FDA Device

• 1 other identifier: CLN013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 venous inflow/outflow obstruction. The main questions the clinical investigation aims to answer are:

1. 1.primary safety endpoint: procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure
2. 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)

Conditions

Venous Obstruction

Keywords

chronic venous disease; chronic venous insufficiency; CEAP classification of C3 or greater; flow-limiting venous outflow obstruction; post-thrombotic syndrome; venous inflow/outflow obstruction

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint - Rates of all Adverse Events through 30-days post-index procedure

  The primary safety objective is procedural events defined as the rates of all adverse events occurring up to 30 days post-index procedure

  30-days post-procedure

• Primary Efficacy Endpoint - Percent Lumen Gain in the Treated Vessel measured at time of procedure

  The primary efficacy assessments include the percent (%) lumen gain during the index procedure, which is measured using intravascular ultrasound (IVUS) at the time of the procedure (perioperative/periprocedural)

  Perioperative/Periprocedural

Other Outcomes (7)

• Assessment of patency (using DUS) in the treated vessel

  30-days post-procedure

• Assessment of primary patency (defined as absence of occlusion and CD-TLR) in the vessel segment at all timepoints

  30-days, 90-days, 180-days and 365-days post-procedure

• Assessment of secondary patency (defined as absence of occlusion and CD-TLR) in the stented vessel segment at all timepoints

  30-days, 90-days, 180-days and 365-days post-procedure

Study Arms (1)

Open-label

EXPERIMENTAL

prospective, non-randomized treatment with the Recana Thrombectomy Catheter System

Device: Recana procedure

Interventions

Recana procedure DEVICE

recanalization and debulking of obstructions and occlusions within stented and non-stented segments in veins

Open-label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intervene, Inc.: lead

Study Sites (1)

University Hospital Galway

Galway, Ireland

RECRUITING

MeSH Terms

Conditions

Postthrombotic Syndrome

Condition Hierarchy (Ancestors)

Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Study Officials

• Gerard O'Sullivan, MD

  University Hospital Galway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Affairs

CONTACT

(650) 995-7137; ClinSupport@intervene-med.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 31, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)