Chronic Venous InsufficiencyReLeafNCT02462096
A Feasibility Study of the ReLeaf Catheter System
A study testing ReLeaf in people with Chronic Venous Insufficiency, run by Intervene, Inc. at 1 site in New Zealand.
Trial summary
This study is designed to evaluate the safety and technical feasibility of the ReLeaf Catheter System in the creation of one or more tissue leaflets in the femoral and/or popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry criteria. 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?
- ReLeaf
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteNew Zealand
- Study dates
- 9 Sep 2015to 5 Jun 2017
- 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
- History of symptomatic chronic venous insufficiency subjects, clinical category CEAP 3 or greater.
- History of failed compression therapy (of at least 6 months), combined with superficial venous or perforator surgery.
- Femoral and/or popliteal venous reflux of ≥ 1.0 seconds.
- Deep system reflux with Kistner classification grade 2 or higher.
- 18 years of age or older at the time of consent.
- Willing and able to sign the Ethics Committee (EC) approved informed consent form.
- Willing to comply with follow-up evaluations and protocols.
Who cannot join
- In the Investigator's opinion, venous outflow obstruction that would inhibit adequate flow away from valve site.
- Obstructive features in the femoral or popliteal vein below the proposed tissue leaflet creation site, which, in the Investigator's opinion, will not allow for sufficient blood flow to the tissue leaflet creation site.
- Deep venous system intervention within 6 months of consent.
- Obstructive features or irregularly small luminal diameter in the femoral vein which, in the opinion of the Investigator, will prohibit access to a tissue leaflet creation site.
- Prior deep vein valve surgical intervention in the ipsilateral limb.
- Ankle arthrodesis with secondary muscle atrophy or severely limited ambulation.
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- Limb-threatening circulatory compromise.
- Contraindications to anticoagulation therapy that cannot be medically controlled.
- History of symptomatic pulmonary embolism.
- Acute venous thromboembolism within 3 months of consent.
- Comorbidity risks which, in the opinion of the Investigator, limit longevity or likelihood of complying with protocol follow up.
- General contraindications to surgery or the use of anesthesia.
- Uncontrolled heart failure, or NYHA Class III or IV heart failure.
- Open Cardiac surgery (e.g. ventriculotomy, atriotomy) within the past 6 months of consent (Interventional procedures such as stenting or PTCA do not apply.)
- Chronic Kidney Disease with creatinine level of 2mg/dL or higher.
- Active systemic infection or sepsis.
- Pregnant or lactating (positive pregnancy test, women of childbearing potential must be tested).
- Appropriate vascular access is precluded.
- Subject is enrolled in any other clinical study that, in the opinion of the Investigator, may conflict with this study or compromise study results.
- Subject is considered at high risk for non-compliance with the protocol (e.g., inaccessible for follow-up).
- Other 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.
- Subject is incarcerated or will be incarcerated during the course of the study.
- Untreated significant superficial venous incompetence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of the InterVene ReLeaf Catheter System in the Creation of Tissue Leaflets in the Femoral and/or Popliteal Vein
This study is designed to evaluate the safety and technical feasibility of the ReLeaf Catheter System in the creation of one or more tissue leaflets in the femoral and/or popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry criteria.
Read the detailed description
The ReLeaf catheter system is intended for the creation of tissue leaflets in the deep veins where existing valve structures are no longer healthy and effectively moving blood.
This study aims to treat subjects with a documented history of symptomatic chronic venous insufficiency in whom compression therapy for at least 6 months, combined with superficial venous and/or perforator surgery have failed to obtain clinical improvement.
This clinical trial is designed to evaluate the safety and technical feasibility of the ReLeaf Catheter System in the creation of one or more tissue leaflets in the femoral and/or popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry criteria.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- ReLeaf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReLeafDevice
Also called Tissue Leaflet Creation, Creation of Valve-like Effect
The ReLeaf catheter is expected to enable a physician to create tissue leaflets that, in turn, generate a valve effect in the deep veins of the legs.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subject to undergo the ReLeaf study procedure. Receives: Device: ReLeaf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Feasibility
Technical feasibility will be evaluated as the ability of the ReLeaf Catheter System to access the target site and successfully modify tissue as confirmed by, and in the opinion of, the Investigator. Successful target site access and confirmed tissue modification will be used as a measure of technical feasibility.
Measured: Day 0
Safety (The number of SAEs directly attributable to the study device will be used as a measure of safety)
Safety will be evaluated as freedom from serious adverse events directly attributed to the investigational device. The number of SAEs directly attributable to the study device will be used as a measure of safety.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study start9 Sep 2015
- Primary completion8 Oct 2016
- Study completion5 Jun 2017
Why it stopped: Device modification and simplification of procedural steps
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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intervene, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462096
- Sponsor's protocol ID
- CLP-0001
- Acronym
- ReLeaf
- Status last verified
- Mar 2018
- First submitted
- 26 May 2015
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
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
- A Feasibility Study of the InterVene ReLeaf Catheter System in the Creation of Tissue Leaflets in the Femoral and/or Popliteal Vein
- ClinicalTrials.gov ID
- NCT02462096
- Acronym / sponsor ID
- ReLeaf / CLP-0001
- Conditions
- Chronic Venous Insufficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device modification and simplification of procedural steps
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Intervene, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2015 (actual)
- Primary completion
- 8 Oct 2016 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 3 Jun 2015 (estimated)
- 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.
This study is designed to evaluate the safety and technical feasibility of the ReLeaf Catheter System in the creation of one or more tissue leaflets in the femoral and/or popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry criteria.
Detailed description
The ReLeaf catheter system is intended for the creation of tissue leaflets in the deep veins where existing valve structures are no longer healthy and effectively moving blood.
This study aims to treat subjects with a documented history of symptomatic chronic venous insufficiency in whom compression therapy for at least 6 months, combined with superficial venous and/or perforator surgery have failed to obtain clinical improvement.
This clinical trial is designed to evaluate the safety and technical feasibility of the ReLeaf Catheter System in the creation of one or more tissue leaflets in the femoral and/or popliteal vein in subjects with chronic venous insufficiency and who meet the protocol entry criteria.
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: ReLeafSubject to undergo the ReLeaf study procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- History of symptomatic chronic venous insufficiency subjects, clinical category CEAP 3 or greater.
- History of failed compression therapy (of at least 6 months), combined with superficial venous or perforator surgery.
- Femoral and/or popliteal venous reflux of ≥ 1.0 seconds.
- Deep system reflux with Kistner classification grade 2 or higher.
- 18 years of age or older at the time of consent.
Key exclusion criteria (24 listed)
- In the Investigator's opinion, venous outflow obstruction that would inhibit adequate flow away from valve site.
- Obstructive features in the femoral or popliteal vein below the proposed tissue leaflet creation site, which, in the Investigator's opinion, will not allow for sufficient blood flow to the tissue leaflet creation site.
- Deep venous system intervention within 6 months of consent.
- Obstructive features or irregularly small luminal diameter in the femoral vein which, in the opinion of the Investigator, will prohibit access to a tissue leaflet creation site.
- Prior deep vein valve surgical intervention in the ipsilateral limb.
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 |
|---|---|---|
| ReLeafAlso: Tissue Leaflet Creation, Creation of Valve-like EffectThe ReLeaf catheter is expected to enable a physician to create tissue leaflets that, in turn, generate a valve effect in the deep veins of the legs. | Device | Treatment |
Primary outcome
Technical Feasibility
Time frame: Day 0
Technical feasibility will be evaluated as the ability of the ReLeaf Catheter System to access the target site and successfully modify tissue as confirmed by, and in the opinion of, the Investigator. Successful target site access and confirmed tissue modification will be used as a measure of technical feasibility.
Safety (The number of SAEs directly attributable to the study device will be used as a measure of safety)
Time frame: Day 30
Safety will be evaluated as freedom from serious adverse events directly attributed to the investigational device. The number of SAEs directly attributable to the study device will be used as a measure of safety.
Results and safety
The study was stopped early (reason given: Device modification and simplification of procedural steps). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReLeaf in people with Chronic Venous Insufficiency, run by Intervene, Inc. at 1 site in New Zealand.
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 7 inclusion and 24 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 5 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 1 site in New Zealand. 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?
The study was stopped early (reason given: Device modification and simplification of procedural steps). Results are not available in the source record.
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?
Technical Feasibility (time frame: Day 0). 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 5 Aug 2025.