Advance® 18PTX® Balloon Catheter Study

This study is currently recruiting participants.

Verified by Cook, February 2009

First Received: October 20, 2008 Last Updated: February 5, 2009 History of Changes

Sponsored by:	Cook
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00776906

Purpose

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	Intervention
Peripheral Arterial Disease	Device: Advance® 18PTX® Balloon Catheter Device: Advance® 18LP Balloon Catheter

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Advance® 18PTX® Balloon Catheter Study: Treatment of Lesions in Superficial Femoral Artery/Popliteal Artery With a Paclitaxel-Coated Balloon

Further study details as provided by Cook:

Primary Outcome Measures:

Evaluation of Late Lumen Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

There are no secondary measures for this study.

Estimated Enrollment:	100
Study Start Date:	October 2008
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PTX-coated balloon	Device: Advance® 18PTX® Balloon Catheter
2: Active Comparator Bare balloon	Device: Advance® 18LP Balloon Catheter

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776906

Contacts

Contact: Priya Bharadwaj

765-463-7537

Bharadwaj@medinst.com

Locations

Germany
Heart Center Leipzig/Park Hospital	Recruiting
Leipzig, Germany, 04289
Contact: Dierk Scheinert +49 341 864 2270 sched@medizin.uni-leipzig.de

Sponsors and Collaborators

Cook

More Information

No publications provided

Responsible Party:	Cook Incorporated ( David Chadwick )
Study ID Numbers:	08-008, 190007
Study First Received:	October 20, 2008
Last Updated:	February 5, 2009
ClinicalTrials.gov Identifier:	NCT00776906 History of Changes
Health Authority:	United States: Institutional Review Board; Germany: German Institute of Medical Documentation and Information

Study placed in the following topic categories:

Peripheral Vascular Diseases
Paclitaxel
Vascular Diseases

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009