Back to resultsA Feasibility Study of the ReLeaf Catheter System (ReLeaf)
Primary Purpose
Chronic Venous Insufficiency
Status
Terminated
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
ReLeaf
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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
Sites / Locations
- Auckland City Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Subject to undergo the ReLeaf study procedure.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02462096
Brief Title
A Feasibility Study of the ReLeaf Catheter System
Acronym
ReLeaf
Official Title
A Feasibility Study of the InterVene ReLeaf Catheter System in the Creation of Tissue Leaflets in the Femoral and/or Popliteal Vein
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Device modification and simplification of procedural steps
Study Start Date
September 9, 2015 (Actual)
Primary Completion Date
October 8, 2016 (Actual)
Study Completion Date
June 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intervene, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subject to undergo the ReLeaf study procedure.
Intervention Type
Device
Intervention Name(s)
ReLeaf
Other Intervention Name(s)
Tissue Leaflet Creation, Creation of Valve-like Effect
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical Feasibility
Description
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.
Time Frame
Day 0
Title
Safety (The number of SAEs directly attributable to the study device will be used as a measure of safety)
Description
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.
Time Frame
Day 30
Other Pre-specified Outcome Measures:
Title
Efficacy
Description
Subsequent efficacy of the treatment following successful creation of the tissue leaflet(s). This will be measured through an assessment of tissue leaflet creation and the tissue leaflets ability to impact blood flow over the course of time.
Time Frame
Day 365
Title
Durability
Description
Long-term durability of the tissue leaflet(s). Confirmation of tissue leaflet existence over time will be used to assess the durability of the tissue leaflet.
Time Frame
Day 365
Title
Long-term Safety (Long-term safety will be measured by freedom from SAEs directly attributable to the study device)
Description
Further long-term safety data will be collected, analyzed and reported through the end of the study. Long-term safety will be measured by freedom from SAEs directly attributable to the study device.
Time Frame
Day 365
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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
Facility Information:
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study of the ReLeaf Catheter System
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