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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03216005




Registration number
NCT03216005
Ethics application status
Date submitted
7/07/2017
Date registered
12/07/2017
Date last updated
10/09/2021

Titles & IDs
Public title
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
Scientific title
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System
Secondary ID [1] 0 0
CLN 003
Universal Trial Number (UTN)
Trial acronym
INFINITE-OUS
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 - BlueLeaf System

Experimental: BlueLeaf System - The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.


Treatment: Devices: BlueLeaf System
The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent decrease in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 30-day follow-up imaging study
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.
Timepoint [2] 0 0
30 days

Eligibility
Key inclusion criteria
- Symptomatic CVI subjects, Clinical Etiological Anatomical Pathophysiological (CEAP)
grade 3 to 6;

- Failed compression therapy of at least 6 months' duration;

- Deep system venous reflux characterized by >1 second reflux time;

- Presence of at least one target site within the target vessel.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Untreated significant superficial venous incompetence which, in the opinion of the
Investigator, may be the primary source of existing symptoms;

- Deep venous intervention in the target limb or outflow vessels within 6 months of
consent;

- Significant peripheral arterial disease with an ankle-brachial index of <0.50 or with
incompressible vessels;

- Acute deep venous thrombosis (DVT) within 3 months of consent;

- History of stroke within the last 6 months;

- Flow-limiting venous outflow obstruction central to the intended target sites;

- Insufficient inflow through the treatment vein upon manual augmentation;

- Chronic, diffuse, post-thrombotic femoropopliteal vein disease that, in the
Investigator's opinion, would preclude venous valve formation or would inhibit flow
through the treatment sites;

- Chronic renal insufficiency with creatinine level of =2mg/dL;

- Hemoglobin level <9.0 mg/dL;

- Platelet count <50,000 or >1,000,000 per mm3;

- Total white blood cell count <3,000/mm3;

- Pregnant or lactating female; positive pregnancy test, women of childbearing potential
must be tested;

- Non-ambulatory patients;

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred - Camperdown
Recruitment hospital [2] 0 0
Prince of Wales - Randwick
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton

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

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous
competence for the treatment of symptomatic chronic venous insufficiency (CVI).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03216005
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Fletcher Wilson
Address 0 0
Intervene, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tracy Roberts
Address 0 0
Country 0 0
Phone 0 0
303-396-4603
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03216005