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NCT00776906 Clinical Trial

Advance® 18PTX® Balloon Catheter Study

Peripheral Arterial Disease Clinical Trial

Official title:
Advance® 18PTX® Balloon Catheter Study: Treatment of Lesions in Superficial Femoral Artery/Popliteal Artery With a Paclitaxel-coated Balloon

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00776906
Other study ID # 08-008
Secondary ID 190007, PCBS
Status Completed
Phase N/A
First received October 20, 2008
Last updated January 19, 2015
Start date October 2008
Est. completion date December 2013

Study information
Verified date February 2014
Source Cook
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardGermany: German Institute of Medical Documentation and Information
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Advance® 18PTX® Balloon Catheter

• Advance® 18LP Balloon Catheter

Locations
Country Name City State
Germany Heart Center Leipzig/Park Hospital Leipzig
Germany Klinikum Rosenheim Rosenheim
Germany Universitat Klinik Tubingen Tubingen
Russian Federation Endosurgery and Lithotripsy Center Moscow

Sponsors (1)
Lead Sponsor Collaborator
Cook

Countries where clinical trial is conducted

Germany,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of Late Lumen Loss 6 months No
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