Chronic Venous InsufficiencyNCT05047302

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

A study testing BlueLeaf Procedure in people with Chronic Venous Insufficiency, run by Intervene, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Venous Insufficiency
What is being tested?: BlueLeaf Procedure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 1 Oct 2022to 1 Nov 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. 18 years of age or older;
2. Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) classification 4 to 6;
3. 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);
4. Willing and able to sign the approved informed consent form (ICF);
5. Willing to comply with follow-up evaluations and protocols;
6. 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;

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7. 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.
8. 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.

Who cannot join

1. 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;
2. 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;
3. Deep venous intervention (includes stenting) in the target limb or outflow vessels within 90 days of consent
4. Significant peripheral arterial disease with an ankle-brachial index of <0.70 or with incompressible vessels;
5. Contraindications to all protocol specified anticoagulation options;
6. Known and uncontrolled hypercoagulopathy (i.e. hypercoagulopathy that cannot be adequately managed/controlled with medication);

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7. Acute deep venous thrombosis (DVT) within 6 months of consent;
8. 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);
9. General contraindications to local, regional or general anesthesia required for the index procedure;
10. NYHA Class III or IV heart failure;
11. Active systemic infection;
12. Women on long-term oral contraceptives;
13. Subject is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results;
14. Invasive surgical procedure within the last 90 days that in the Investigator's opinion would interfere with the study procedure or results;
15. History of stroke within the last 6 months;
16. Flow-limiting venous outflow obstruction central to the intended target sites, defined by a common femoral vein duplex exam found to have a continuous waveform without respiratory variation or a 50% or greater reduction in luminal cross-sectional area on IVUS;
17. Inadequate flow into or through the target vessel (Investigator's opinion);
18. Anatomy that does not support proper device access of the treatment vein through the ipsilateral common femoral or femoral vein;
19. Luminal diameter <7 mm between the vein access site and the intended treatment site, as assessed by IVUS, while the vein is under physiologically appropriate hemodynamic pressure;
20. A competent vein valve in any vein segment through which the device is likely to be inserted (common femoral or femoral vein)
21. Chronic renal insufficiency with creatinine level of ≥2mg/dL;
22. Hemoglobin level <9.0 mg/dL;
23. Platelet count <50,000 or >1,000,000 per mm3;
24. Total white blood cell count <3,000/mm3;
25. Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested;
26. Non-ambulatory patients;
27. Patients with a history of right heart failure occurring as a consequence of, for example, biventricular failure, intrinsic pulmonary disease, chronic thromboembolic pulmonary hypertension, and other etiologies that result in elevated right-sided pressures.

About this study

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.

Read the detailed description

STUDY DESIGN: The Study is a prospective, non-randomized study to evaluate participants treated with the BlueLeaf System for the restoration of deep venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).

STUDY OVERVIEW: Potential participants who pass pre-screening and are willing to participate in the study will be asked to sign the study Informed Consent Form before any study-specific tests or procedures are performed or for any study specific evaluations not considered standard of care that need to be performed to assess eligibility.

Eligible participants may undergo the index procedure. Adverse events are assessed. All participants enrolled in the study are evaluated at pre-specified timepoints.

STUDY POPULATION: Patients with CVI and a Clinical Etiological Anatomical Pathophysiological (CEAP) classification of 4, 5, or 6.

STUDY ENROLLMENT: Up to 50 subjects will be enrolled.

Conditions: Chronic Venous Insufficiency
Being tested: BlueLeaf Procedure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05047302
Study group	Role	What they receive
Treatment	Experimental	The goal of the BlueLeaf System is to percutaneously form one or more functional, autogenous deep venous valves and restore venous competence. Receives: Device: BlueLeaf Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Venous Clinical Severity Score (VCSS)
A decrease in score from baseline
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20221 Nov 2026

First posted17 Sep 2021
Study start1 Oct 2022 (estimated)
Primary completion1 Nov 2025 (estimated)
Study completion1 Nov 2026 (estimated)

Why it stopped: Project suspended by sponsor

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05047302
Sponsor's protocol ID: CLN009
Status last verified: Jul 2025
First submitted: 8 Sep 2021
Last updated: 5 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
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A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Active, not recruitingObservational study
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral)

All Chronic Venous Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-Canada)
ClinicalTrials.gov ID: NCT05047302
Acronym / sponsor ID: CLN009
Conditions: Chronic Venous Insufficiency
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Project suspended by sponsor
Enrolment: 0 participants (actual)
Lead sponsor: Intervene, Inc.Industry (pharma, biotech, devices)
Study start: 1 Oct 2022 (estimated)
Primary completion: 1 Nov 2025 (estimated)
Study completion: 1 Nov 2026 (estimated)
First posted: 17 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Eligible participants may undergo the index procedure. Adverse events are assessed. All participants enrolled in the study are evaluated at pre-specified timepoints.

STUDY POPULATION: Patients with CVI and a Clinical Etiological Anatomical Pathophysiological (CEAP) classification of 4, 5, or 6.

STUDY ENROLLMENT: Up to 50 subjects will be enrolled.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Device: BlueLeaf ProcedureThe goal of the BlueLeaf System is to percutaneously form one or more functional, autogenous deep venous valves and restore venous competence.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

1. 18 years of age or older;
2. Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) classification 4 to 6;
3. 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);
4. Willing and able to sign the approved informed consent form (ICF);
5. Willing to comply with follow-up evaluations and protocols;

Key exclusion criteria (27 listed)

1. 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;
2. 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;
3. Deep venous intervention (includes stenting) in the target limb or outflow vessels within 90 days of consent
4. Significant peripheral arterial disease with an ankle-brachial index of <0.70 or with incompressible vessels;
5. Contraindications to all protocol specified anticoagulation options;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BlueLeaf ProcedureThe device is intended to form autogenous tissue leaflets from vein walls without the use of a permanent vascular implant.	Device	Treatment

Primary outcome

Change in Venous Clinical Severity Score (VCSS)
Time frame: 1 year
A decrease in score from baseline

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
Individual participant dataSharing planned: No

Related trials for Chronic Venous Insufficiency

Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Active, not recruitingObservational study
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeff Elkins study director

Intervene, Inc.

Questions about this trial

What is this clinical trial studying?

A study testing BlueLeaf Procedure in people with Chronic Venous Insufficiency, run by Intervene, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Venous Clinical Severity Score (VCSS) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05047302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.