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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02462096




Registration number
NCT02462096
Ethics application status
Date submitted
26/05/2015
Date registered
3/06/2015
Date last updated
29/03/2018

Titles & IDs
Public title
A Feasibility Study of the ReLeaf Catheter System
Scientific title
A Feasibility Study of the InterVene ReLeaf Catheter System in the Creation of Tissue Leaflets in the Femoral and/or Popliteal Vein
Secondary ID [1] 0 0
CLP-0001
Universal Trial Number (UTN)
Trial acronym
ReLeaf
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Venous Insufficiency 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ReLeaf

Experimental: Treatment - Subject to undergo the ReLeaf study procedure.


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 0
Primary outcome [2] 0 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.
Timepoint [2] 0 0
Day 30

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Intervene, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02462096
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02462096