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A Feasibility Study of the ReLeaf Catheter System (ReLeaf)

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ClinicalTrials.gov Identifier: NCT02462096
Recruitment Status : Terminated (Device modification and simplification of procedural steps)
First Posted : June 3, 2015
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Intervene, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Venous Insufficiency Device: ReLeaf Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of the InterVene ReLeaf Catheter System in the Creation of Tissue Leaflets in the Femoral and/or Popliteal Vein
Actual Study Start Date : September 9, 2015
Actual Primary Completion Date : October 8, 2016
Actual Study Completion Date : June 5, 2017

Arm Intervention/treatment
Experimental: Treatment
Subject to undergo the ReLeaf study procedure.
Device: ReLeaf
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.
Other Name: Tissue Leaflet Creation, Creation of Valve-like Effect




Primary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Efficacy [ Time Frame: Day 365 ]
    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.

  2. Durability [ Time Frame: Day 365 ]
    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.

  3. Long-term Safety (Long-term safety will be measured by freedom from SAEs directly attributable to the study device) [ Time Frame: Day 365 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462096


Locations
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New Zealand
Auckland City Hospital
Auckland, New Zealand
Sponsors and Collaborators
Intervene, Inc.

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Responsible Party: Intervene, Inc.
ClinicalTrials.gov Identifier: NCT02462096     History of Changes
Other Study ID Numbers: CLP-0001
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases