Chronic Venous InsufficiencyINFINITE-OUSNCT03216005

Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

A study testing BlueLeaf System in people with Chronic Venous Insufficiency, run by Intervene, Inc. at 5 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI). 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 System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 5 sitesin 3 countries
Study dates: 2 Nov 2017to 30 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6;
Failed compression therapy of at least 6 months' duration;
Deep system venous reflux characterized by >1 second reflux time;
Presence of at least one target site within the target vessel.

Who cannot join

Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms;
Deep venous intervention in the target limb or outflow vessels within 6 months of consent;
Significant peripheral arterial disease with an ankle-brachial index of <0.50 or with incompressible vessels;
Acute deep venous thrombosis (DVT) within 3 months of consent;
History of stroke within the last 6 months;
Flow-limiting venous outflow obstruction central to the intended target sites;

Show all 14Show fewer

Insufficient inflow through the treatment vein upon manual augmentation;
Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the Investigator's opinion, would preclude venous valve formation or would inhibit flow through the treatment sites;
Chronic renal insufficiency with creatinine level of ≥2mg/dL;
Hemoglobin level <9.0 mg/dL;
Platelet count <50,000 or >1,000,000 per mm3;
Total white blood cell count <3,000/mm3;
Pregnant or lactating female; positive pregnancy test, women of childbearing potential must be tested;
Non-ambulatory patients;

Trial locations and contacts

5 sites in 3 countries.

Country

City, postcode or hospital

5 sites in 3 countries

Australia2 sites

Royal Prince Alfred
Camperdown, New South Wales, 2050
Prince of Wales
Randwick, New South Wales, 2031

Other trials in Australia

New Zealand2 sites

Auckland City Hospital
Auckland
Clinical Trials New Zealand Ltd
Hamilton

Other trials in New Zealand

Canada1 site

Vancouver Coastal Health Research Institute
Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).

Read the detailed description

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. The BlueLeaf System is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of CVI. Subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment.

Conditions: Chronic Venous Insufficiency
Being tested: BlueLeaf System

What participants receive

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

BlueLeaf SystemDevice
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

Study groups in NCT03216005
Study group	Role	What they receive
BlueLeaf System	Experimental	The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function. Receives: Device: BlueLeaf System

What is being measured

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

Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment
Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up
Measured: Baseline, 7-day, 30-day
Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT)
Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit
Measured: 30-day post-procedure

Secondary outcomes (2)

Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment
Rates (count) of participants with DVTs in the target vessel at the 90-day and 210-day follow-up assessed by follow-up imaging
Measured: 90-day, 210-day
Change in Reflux Time (RT) in the Primary Treated Vein Segment
Assessment of the reflux time in the primary treated vein segment. Change in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 90-day and 210-day follow-up visits were assessed; the outcome is reported as the % change in the reflux time from Baseline
Measured: 90-day, 210-day

Timeline

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

2 Nov 201730 Oct 2023

First posted12 Jul 2017
Study start2 Nov 2017
Primary completion30 Oct 2023
Study completion30 Oct 2023

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.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Model description: prospective, non-randomized, multicenter pre-market feasibility study
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03216005
Sponsor's protocol ID: CLN003
Acronym: INFINITE-OUS
Status last verified: Apr 2026
First submitted: 7 Jul 2017
Last updated: 23 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
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?

See locations

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The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
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Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
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All Chronic Venous Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2026. 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
ClinicalTrials.gov ID: NCT03216005
Acronym / sponsor ID: INFINITE-OUS / CLN003
Conditions: Chronic Venous Insufficiency
Study type: Interventional
Recruitment status: TerminatedReason stopped: Project suspended by sponsor
Enrolment: 14 participants (actual)
Lead sponsor: Intervene, Inc.Industry (pharma, biotech, devices)
Study start: 2 Nov 2017 (actual)
Primary completion: 30 Oct 2023 (actual)
Study completion: 30 Oct 2023 (actual)
First posted: 12 Jul 2017 (actual)
Results: Posted 23 Apr 2026

Clinical summary

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

To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: prospective, non-randomized, multicenter pre-market feasibility study

Arm	Type	Receives
BlueLeaf System	Experimental	Device: BlueLeaf SystemThe BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

Who may qualify

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

Key inclusion criteria (4 listed)

Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP) grade 3 to 6;
Failed compression therapy of at least 6 months' duration;
Deep system venous reflux characterized by >1 second reflux time;
Presence of at least one target site within the target vessel.

Key exclusion criteria (14 listed)

Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms;
Deep venous intervention in the target limb or outflow vessels within 6 months of consent;
Significant peripheral arterial disease with an ankle-brachial index of <0.50 or with incompressible vessels;
Acute deep venous thrombosis (DVT) within 3 months of consent;
History of stroke within the last 6 months;

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 SystemThe BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.	Device	BlueLeaf System

Primary outcome

Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment
Time frame: Baseline, 7-day, 30-day
Change in reflux time (reported as % change) in the primary treated vessel from pre-procedure baseline compared to the 30-day follow-up
Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT)
Time frame: 30-day post-procedure
Rates (count) of participant with DVTs in the target vessel at the 30-day time point - analyzed for subjects that completed the 30-day follow-up visit

2 secondary outcomes

Number of Participants With Target Vessel Deep Venous Thrombosis (DVT) in the Primary Treated Vein Segment
Time frame: 90-day, 210-day
Change in Reflux Time (RT) in the Primary Treated Vein Segment
Time frame: 90-day, 210-day

Results and safety

Results posted to the registry on 23 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BlueLeaf System	14	0

Primary outcome: Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment

Time frame: Baseline, 7-day, 30-day. Mean (Standard Deviation). Unit: percentage change from Baseline

Measure	BlueLeaf System - Proximal Femoral Vein (FV) Segment n = 11	BlueLeaf System - Distal Femoral Vein (FV) Segment n = 11	BlueLeaf System - Mid Popliteal Segment n = 11
7-day % change from Baseline	32.0 (72.5)	41.2 (54.3)	59.1 (67.6)
30-day % change from Baseline	18.8 (85.3)	39.3 (80.6)	65.1 (94.3)

Population analysed: Subjects that underwent the investigational procedure and were seen at the 30-day follow-up

Primary outcome: Primary Safety: Number of Participants With Target Vessel Deep Venous Thrombosis (DVT)

Time frame: 30-day post-procedure. Count of participants. Unit: Participants

Measure	BlueLeaf System - Proximal Femoral Vein (FV) Segment n = 7	BlueLeaf System - Distal Femoral Vein (FV) Segment n = 8	BlueLeaf System - Mid Popliteal Segment n = 8
Value	0	0	0

Population analysed: Subjects that underwent the investigational procedure, were seen at the 30-day follow-up and imaging study was performed

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 210-days post-procedure (longest follow-up available at the time of trial termination). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BlueLeaf System	3 of 11 (27.3%)	11 of 11 (100%)	0 of 11

Limitations and caveats (from the sponsor): The trial was terminated early leading to a limited number of subjects analyzed. Specifically, there was limited data available for reporting purposes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

5 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BlueLeaf System in people with Chronic Venous Insufficiency, run by Intervene, Inc. at 5 sites in 3 countries.

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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia, New Zealand, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Primary Effectiveness: Change in Reflux Time (RT) in the Primary Treated Vein Segment (time frame: Baseline, 7-day, 30-day). The study lists 2 primary outcomes in all. 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 NCT03216005.

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 23 Apr 2026.