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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COMPLETED
NA
150 participants
INTERVENTIONAL
2008-10-31
2013-12-31
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
NONE
Study Groups
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1
PTX-coated balloon
Advance® 18PTX® Balloon Catheter
2
Bare balloon
Advance® 18LP Balloon Catheter
Interventions
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Advance® 18PTX® Balloon Catheter
Advance® 18LP Balloon Catheter
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent.
* Has at least one de novo or restenotic lesion(s) with \> 70% stenosis documented angiographically of the SFA or popliteal artery. If more than one lesion requires intervention, only one should be treated as a study lesion.
Exclusion Criteria
* Lack of at least one patent runoff vessel with \< 50% stenosis throughout its course.
* Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery.
18 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
Responsible Party
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Locations
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Heart Center Leipzig/Park Hospital
Leipzig, , Germany
Klinikum Rosenheim
Rosenheim, , Germany
Universitat Klinik Tubingen
Tübingen, , Germany
Endosurgery and Lithotripsy Center
Moscow, , Russia
Countries
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Other Identifiers
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190007, PCBS
Identifier Type: -
Identifier Source: secondary_id
08-008
Identifier Type: -
Identifier Source: org_study_id
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