Advance® 18PTX® Balloon Catheter Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00776906 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Last Update Posted : January 21, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Arterial Disease | Device: Advance® 18PTX® Balloon Catheter Device: Advance® 18LP Balloon Catheter | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Advance® 18PTX® Balloon Catheter Study: Treatment of Lesions in Superficial Femoral Artery/Popliteal Artery With a Paclitaxel-coated Balloon |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
PTX-coated balloon
|
Device: Advance® 18PTX® Balloon Catheter |
Active Comparator: 2
Bare balloon
|
Device: Advance® 18LP Balloon Catheter |
- Evaluation of Late Lumen Loss [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Age >18 years.
- 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.
Key Exclusion Criteria:
- Has significant stenosis (> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776906
Germany | |
Heart Center Leipzig/Park Hospital | |
Leipzig, Germany, 04289 | |
Klinikum Rosenheim | |
Rosenheim, Germany, 83022 | |
Universitat Klinik Tubingen | |
Tubingen, Germany, 72076 | |
Russian Federation | |
Endosurgery and Lithotripsy Center | |
Moscow, Russian Federation, 111123 |
Responsible Party: | Cook Group Incorporated |
ClinicalTrials.gov Identifier: | NCT00776906 |
Other Study ID Numbers: |
08-008 190007, PCBS |
First Posted: | October 22, 2008 Key Record Dates |
Last Update Posted: | January 21, 2015 |
Last Verified: | February 2014 |
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |