Advance® 18PTX® Balloon Catheter Study

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT00776906
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of Late Lumen Loss	6 months

Trial Locations

Locations (4)

Heart Center Leipzig/Park Hospital; 🇩🇪 Leipzig, Germany

Klinikum Rosenheim; 🇩🇪 Rosenheim, Germany

Universitat Klinik Tubingen; 🇩🇪 Tubingen, Germany

Endosurgery and Lithotripsy Center; 🇷🇺 Moscow, Russian Federation