A Feasibility Study of the ReLeaf Catheter System

NCT02462096 | Terminated DMC

• 1 other identifier: CLP-0001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 30

Other Outcomes (3)

• Subsequent Efficacy of Treatment

  Day 365

• Durability

  Day 365

• Long-term Safety (Long-term safety will be measured by freedom from SAEs directly attributable to the study device)

  Day 365

Study Arms (1)

Treatment

EXPERIMENTAL

Subject to undergo the ReLeaf study procedure.

Device: ReLeaf

Interventions

ReLeaf DEVICE

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.

Also known as: Tissue Leaflet Creation, Creation of Valve-like Effect

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intervene, Inc.: lead

Study Sites (1)

Auckland City Hospital

Auckland, New Zealand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 3, 2015
• Study Start: September 9, 2015
• Primary Completion: October 8, 2016
• Study Completion: June 5, 2017
• Last Updated: August 5, 2025

Record last verified: 2018-03

Locations

NZ (1)