Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-Canada)

NCT05047302 | Withdrawn DMC

• 1 other identifier: CLN009
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity.

Conditions

Chronic Venous Insufficiency

Outcome Measures

Primary Outcomes (1)

• Change in Venous Clinical Severity Score (VCSS)

  A decrease in score from baseline

  1 year

Study Arms (1)

Treatment

EXPERIMENTAL

The goal of the BlueLeaf System is to percutaneously form one or more functional, autogenous deep venous valves and restore venous competence.

Device: BlueLeaf Procedure

Interventions

BlueLeaf Procedure DEVICE

The device is intended to form autogenous tissue leaflets from vein walls without the use of a permanent vascular implant.

Treatment

Eligibility Criteria

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

You may qualify if:

• \. 18 years of age or older;
• \. Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) classification 4 to 6;
• \. Failed at least 6 months of conservative therapy at some point during the course of their CVI management (symptoms not adequately resolved or patient non-compliant/unable to tolerate);
• \. Willing and able to sign the approved informed consent form (ICF);
• \. Willing to comply with follow-up evaluations and protocols;
• \. Deep system venous reflux characterized by \>1 second reflux time in two contiguous vein segments (vein segments defined as: proximal femoral, distal femoral, and popliteal), as assessed by DUS with patient in the standing position;
• \. Presence of at least two potential target sites within the target vessel, which is defined as a segment within the femoral or popliteal vein that is:
• not less than 7mm in luminal diameter, and
• not more than 11mm in luminal diameter, and
• at least 3cm long (two target sites in a row must be spaced at least 1cm apart), and
• absent severe obstructive features such as thrombus, synechiae, natural valves, major tributaries (valves can be formed opposite tributaries) or severe heterogeneous fibrotic changes of the vessel wall which, in the Investigator's opinion, would preclude formation of a valve, as preliminary assessed by DUS, and then by IVUS, while the vein is under physiologically appropriate hemodynamic pressure, with IVUS being the definitive modality.
• \. In the Investigator's opinion, the subject is a good candidate for treatment with the BlueLeaf System based on their symptoms, quality of life, anatomy, and the likelihood of benefit from continued conservative therapy.

You may not qualify if:

• \. Untreated significant superficial venous incompetence within 30 days of screening which, in the opinion of the Investigator, may be the primary source of existing symptoms;
• \. A competent vein valve in any vein segment through which the device is likely to be inserted, as assessed by DUS (\<1 second reflux time) or with contrast venography (Investigator's opinion);Deep venous intervention (includes stenting) in the target limb or outflow vessels within 90 days of consent;
• \. Deep venous intervention (includes stenting) in the target limb or outflow vessels within 90 days of consent
• \. Significant peripheral arterial disease with an ankle-brachial index of \<0.70 or with incompressible vessels;
• \. Contraindications to all protocol specified anticoagulation options;
• \. Known and uncontrolled hypercoagulopathy (i.e. hypercoagulopathy that cannot be adequately managed/controlled with medication);
• \. Acute deep venous thrombosis (DVT) within 6 months of consent;
• \. Comorbidity risks or other concerns (e.g. recent cancer) which, in the opinion of the Investigator, limit longevity or likelihood of complying with the protocol and its prescribed follow up or would preclude the patient from open surgery in the event of a complication requiring surgical intervention (e.g. severe vein laceration);
• \. General contraindications to local, regional or general anesthesia required for the index procedure;
• \. NYHA Class III or IV heart failure;
• \. Active systemic infection;
• \. Women on long-term oral contraceptives;
• \. Subject is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results;
• \. Invasive surgical procedure within the last 90 days that in the Investigator's opinion would interfere with the study procedure or results;
• \. History of stroke within the last 6 months;

Sponsors & Collaborators

• Intervene, Inc.: lead

Study Officials

• Jeff Elkins

  Intervene, Inc.

  STUDY DIRECTOR

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: September 8, 2021
• First Posted: September 17, 2021
• Study Start: October 1, 2022
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share