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Advance® 18PTX® Balloon Catheter Study

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
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Study Description
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Brief Summary:
The Advance® 18 PTX® Balloon Catheter study is a clinical trial to study the safety and effectiveness of the Advance 18® PTX® Balloon Catheter in the treatment of lesions in the superficial femoral artery and popliteal artery.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Advance® 18PTX® Balloon Catheter Device: Advance® 18LP Balloon Catheter Not Applicable

Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
PTX-coated balloon
 Device: Advance® 18PTX® Balloon Catheter
Active Comparator: 2
Bare balloon
 Device: Advance® 18LP Balloon Catheter


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of Late Lumen Loss [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Cook Group Incorporated
More Information
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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
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases