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Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System

RECRUITING

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).

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Study details:

Prospective, non-randomized, multicenter pre-market feasibility study to evaluate subjects treated with the BlueLeaf System for the treatment of symptomatic CVI of the lower extremity. The BlueLeaf System is designed to form autogenous tissue leaflets from vein walls in the femoral and popliteal veins without the use of a permanent vascular implant for the treatment of CVI. Subjects meeting eligibility criteria will be enrolled and may be followed through 5 years post treatment.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2017-11-02

Primary completion: 2025-12-01

Study completion finish: 2025-12-01

Study type

TREATMENT

Phase

Trial ID

NCT03216005

Intervention or treatment

DEVICE: BlueLeaf System

Conditions

• Chronic Venous Insufficiency

Image related to Chronic Venous Insufficiency

Condition: Chronic Venous Insufficiency
DEVICE: BlueLeaf System
Camperdown, New South Wales, Australia and more
Sponsor: Intervene, Inc.

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Find a site

Closest Location:

Royal Prince Alfred

Research sites nearby

Select from list below to view details:

Royal Prince Alfred
Camperdown, New South Wales, Australia
Prince of Wales
Randwick, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: BlueLeaf System The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.	DEVICE: BlueLeaf System The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Percent decrease in reflux time (RT) in the primary treated vein segment from pre-procedure baseline to the 30-day follow-up imaging study	Not Specified	30 days
Freedom from target vessel deep venous thrombosis (DVT) at the 30-day follow-up imaging study.	Not Specified	30 days

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System