Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis
NCT ID: NCT02568293
Last Updated: 2017-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
66 participants
INTERVENTIONAL
2015-10-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SBCV
SBCV is administered to the site immediately post balloon dilation.
SBCV
SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.
Control
Saline is used as a control and is delivered immediately post balloon dilation.
Saline
Saline is used as a control.
Interventions
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SBCV
SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.
Saline
Saline is used as a control.
Eligibility Criteria
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Inclusion Criteria
* Rutherford Clinical Category 1-4 (claudication or critical limb ischemia)
* Lesions are ≥70% stenosis by visual estimate
* A patent inflow artery free from significant lesion
* At least one patent native outflow artery to the ankle
Exclusion Criteria
* History of myocardial infarction, thrombolysis or angina within 2 weeks of screening
* Renal failure or chronic kidney disease
* Severe calcification that renders the lesion undilatable
40 Years
ALL
No
Sponsors
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Symic Biomedical, Inc.
INDUSTRY
Symic Vascular
INDUSTRY
Responsible Party
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Locations
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Royal Prince Alfred Hospital
Melbourne, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Flinders Medical Center
Adelaide, South Australia, Australia
Austin Health
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Auckland City Hospital
Auckland, , New Zealand
Countries
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Other Identifiers
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TP-1601
Identifier Type: -
Identifier Source: org_study_id
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