Chronic Venous Insufficiency (CVI)INFINITE-USNCT04225806
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System (INFINITE-US)
A study testing BlueLeaf® Endovenous Valve Formation System (BlueLeaf System) in people with Chronic Venous Insufficiency (CVI) and Deep Vein Reflux, run by Intervene, Inc. at 5 sites in United States.
Trial summary
Prospective, non-randomized, multicenter pre-market early feasibility study (EFS) to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic chronic venous insufficiency (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 (CVI), Deep Vein Reflux
- What is being tested?
- BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Feb 2020to 30 Sep 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
- 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)
- Deep system venous reflux characterized by >1 second reflux time in two vein segments (vein segments defined as: proximal femoral, distal femoral, and popliteal), as assessed by duplex ultrasound (DUS) with patient in the standing position
- Presence of at least two potential target sites within a target vessel as assessed preliminarily by DUS, with a target site being defined as a segment within the femoral or popliteal vein that is:
- 7mm to 11mm in luminal diameter and at least 3cm long and absent features that, in the Investigator's opinion, would preclude formation of a monocuspid valve (at any orientation).
- 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
- Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms
- Acute deep venous thrombosis (DVT) within 1 year of consent
- Deep venous intervention (includes stenting) in the target limb or outflow vessels within 3 months of consent
- 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
- Contraindications to all protocol specified anticoagulation options
- Known and uncontrolled hypercoagulopathy (i.e. hypercoagulopathy that cannot be adequately managed/controlled with medication)
Show all 19Show fewer
- Women on long-term oral contraceptives
- Non-ambulatory patients
- Significant peripheral arterial disease with an ankle-brachial index of < 0.70 or with incompressible vessels
- New York Heart Association Class III or IV heart failure
- 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.
- Active systemic infection
- Invasive surgical procedure within the last 3 months that in the Investigator's opinion would interfere with the study procedure or results
- Chronic renal insufficiency with creatinine level of ≥ 2mg/dL
- Hemoglobin level < 9.0 mg/dL
- Platelet count < 50,000 or > 1,000,000/mm3
- Total white blood cell count < 3,000/mm3
- Subject is enrolled in another clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results
- Comorbidity risks or other concerns which, in the opinion of the Investigator, either limits longevity or likelihood of complying with the protocol and its prescribed follow up (e.g. recent cancer or stroke); or precludes patient from being transitioned to open surgery if complication requiring surgical intervention occurs during the procedure (such as severe vein laceration).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
The Vascular Experts
Darien, Connecticut, 06820
NYU Langone Medical Center
New York, New York, 10016
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Prospective, non-randomized, multicenter pre-market early feasibility study (EFS) to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic chronic venous insufficiency (CVI) of the lower extremity
Read the detailed description
The purpose of this early feasibility study is to provide information on the BlueLeaf System for the formation of one or more autogenous vein valves constructed from the vein wall of the femoral and/or popliteal vein, in subjects with CVI and who meet the specified eligibility criteria. In particular, the safety and technical feasibility of the procedure will be validated in patients in the United States, including the procedural steps, operator technique, and subject characteristics. The study will assess the safety and effectiveness of the study device acutely and through 5 years.
- Being tested
- BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)Device
The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | Subjects will be treated with the investigational device and followed per protocol. Receives: Device: BlueLeaf® Endovenous Valve Formation System (BlueLeaf System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: The Number of Subjects Experiencing a Major Adverse Event (MAE), Composed of the Following
- Symptomatic pulmonary embolism
- DVT anywhere in the deep venous system of the treatment limb
- Occlusive valve pocket thrombus (VPT)
- Non-occlusive stenosis in the target vessel (including due to scarring, inflammation, VPT, etc.) leading to persistent worsening of symptoms attributable to venous flow obstruction, or requiring post-procedural surgical or endovascular re-intervention
- Device or procedure-related venous or arterial injury in the treated limb (such as Arteriovenous Fistula (AVF's), bleeding, pseudo aneurysm) leading to worsening of symptoms that require post-procedural surgical or endovascular re-intervention or requiring transfusion of more than 2 units of blood. (Note: Peri-procedural stiches placed to assist with closure of the access site will not be characterized as a primary safety failure.)
- Device or procedure-related death
Measured: 30-day post-procedure
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
Assessment of changes in the rVCSS; the score is a composite based on a rating score of none (0), mild (1), moderate (2) and severe (3) for symptoms and clinical signs, the number of active ulcers (0, 1, 2, >/=3), duration of ulcers (<3 months, >3 months but <1 year, not healed for >1 year), active ulcer size (diameter <2cm, diameter 2-6cm, and diameter >6cm), and use of compression therapy (not used (0), intermittent use of stockings (1), wears stockings most days (2), and full compliance (3)). A higher VCSS would indicate a worse outcome.
Measured: Baseline, 30-days, 12-weeks, 210-days and 365-days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start13 Feb 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 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 Insufficiency (CVI)Studies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intervene, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Elkins, Study director, Intervene, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225806
- Sponsor's protocol ID
- CLN004
- Acronym
- INFINITE-US
- Status last verified
- Aug 2025
- First submitted
- 7 Jan 2020
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 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-US)
- ClinicalTrials.gov ID
- NCT04225806
- Acronym / sponsor ID
- INFINITE-US / CLN004
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project suspended by Sponsor
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Intervene, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 19 Aug 2025
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 early feasibility study (EFS) to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic chronic venous insufficiency (CVI) of the lower extremity
Detailed description
The purpose of this early feasibility study is to provide information on the BlueLeaf System for the formation of one or more autogenous vein valves constructed from the vein wall of the femoral and/or popliteal vein, in subjects with CVI and who meet the specified eligibility criteria. In particular, the safety and technical feasibility of the procedure will be validated in patients in the United States, including the procedural steps, operator technique, and subject characteristics. The study will assess the safety and effectiveness of the study device acutely and through 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Device: BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)Subjects will be treated with the investigational device and followed per protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
- Deep system venous reflux characterized by >1 second reflux time in two vein segments (vein segments defined as: proximal femoral, distal femoral, and popliteal), as assessed by duplex ultrasound (DUS) with patient in the standing position
- Presence of at least two potential target sites within a target vessel as assessed preliminarily by DUS, with a target site being defined as a segment within the femoral or popliteal vein that is:
- 7mm to 11mm in luminal diameter and at least 3cm long and absent features that, in the Investigator's opinion, would preclude formation of a monocuspid valve (at any orientation).
- 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
Key exclusion criteria (19 listed)
- Untreated significant superficial venous incompetence which, in the opinion of the Investigator, may be the primary source of existing symptoms
- Acute deep venous thrombosis (DVT) within 1 year of consent
- Deep venous intervention (includes stenting) in the target limb or outflow vessels within 3 months of consent
- 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
- 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® Endovenous Valve Formation System (BlueLeaf System)The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated. | Device | Investigational |
Primary outcome
Primary Safety Endpoint: The Number of Subjects Experiencing a Major Adverse Event (MAE), Composed of the Following
Time frame: 30-day post-procedure
* Symptomatic pulmonary embolism * DVT anywhere in the deep venous system of the treatment limb * Occlusive valve pocket thrombus (VPT) * Non-occlusive stenosis in the target vessel (including due to scarring, inflammation, VPT, etc.) leading to persistent worsening of symptoms attributable to venous flow obstruction, or requiring post-procedural surgical or endovascular re-intervention * Device or procedure-related venous or arterial injury in the treated limb (such as Arteriovenous Fistula (AVF's), bleeding, pseudo aneurysm) leading to worsening of symptoms that require post-procedural surgical or endovascular re-intervention or requiring transfusion of more than 2 units of blood. (Note: Peri-procedural stiches placed to assist with closure of the access site will not be characterized as a primary safety failure.) * Device or procedure-related death
Change in Revised Venous Clinical Severity Score (rVCSS) From Baseline
Time frame: Baseline, 30-days, 12-weeks, 210-days and 365-days post-procedure
Assessment of changes in the rVCSS; the score is a composite based on a rating score of none (0), mild (1), moderate (2) and severe (3) for symptoms and clinical signs, the number of active ulcers (0, 1, 2, >/=3), duration of ulcers (<3 months, >3 months but <1 year, not healed for >1 year), active ulcer size (diameter <2cm, diameter 2-6cm, and diameter >6cm), and use of compression therapy (not used (0), intermittent use of stockings (1), wears stockings most days (2), and full compliance (3)). A higher VCSS would indicate a worse outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BlueLeaf® Endovenous Valve Formation System (BlueLeaf System) in people with Chronic Venous Insufficiency (CVI) and Deep Vein Reflux, run by Intervene, Inc. at 5 sites in United States.
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 5 inclusion and 19 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 19 Aug 2025. 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 United States. 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 19 Aug 2025). 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 Safety Endpoint: The Number of Subjects Experiencing a Major Adverse Event (MAE), Composed of the Following (time frame: 30-day post-procedure). 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?
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 19 Aug 2025.