Vienna Absolute Trial: Balloon Angioplasty Versus Stenting in the Superficial Femoral Artery

This study has been completed.

First Received on January 20, 2006. Last Updated on July 26, 2006 History of Changes

Sponsor:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00281060

Purpose

Minimal invasive treatment (called "endovascular") of the arteries of the lower limb remains problematic, because recurrent disease ("restenosis") frequently leads to recurrent symptoms. As yet, balloon angioplasty remains the recommended strategy to revascularize the superficial femoral artery (artery of the thigh). We investigated whether the use of a vascular endoprosthesis ("stent") improves patients´ outcome.

Study hypothesis: Primary stenting with self expanding nitinol stents may improve patency after endovascular treatment of superficial femoral artery obstructions compared to balloon angioplasty with optional stenting.

Condition	Intervention	Phase
Atherosclerosis	Procedure: primary stenting	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Balloon Angioplasty Versus Stenting With Nitinol Stents in the Superficial Femoral Artery

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Atherosclerosis

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Angiographic restenosis at 6 months

Secondary Outcome Measures:

restenosis by duplex ultrasound at 3,6 and 12 months
walking distance on the treadmill at 3, 6 and 12 months
ankle brachial index at 3, 6 and 12 months
stent fractures at 6 and 12 months

Estimated Enrollment:	110
Study Start Date:	June 2003
Estimated Study Completion Date:	August 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Symptomatic peripheral artery disease Rutherford stages 3 to 5
>50% stenosis of the ipsilateral superficial femoral artery
Lesion length >30mm
At least one patent crural run-off vessel,

Exclusion Criteria:

Acute criticla limb ischemia
Previous ipsilateral bypass surgery or ipsilateral SFA stenting
Untreated inflow disease
Known intolerance to clopidogrel, aspirin or radiocontrast

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281060

Locations

Austria
Medical University Vienna
Vienna, Austria, A 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Martin Schillinger, MD

Medical University Vienna

More Information

Publications:

Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88.

ClinicalTrials.gov Identifier:	NCT00281060 History of Changes
Other Study ID Numbers:	EK164/2003
Study First Received:	January 20, 2006
Last Updated:	July 26, 2006
Health Authority:	Austria: Ministry of Health

Keywords provided by Medical University of Vienna:

endovascular
balloon angioplasty
stents

Additional relevant MeSH terms:

Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2012