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

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. Identifier: NCT00281060
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : July 27, 2006
Information provided by:
Medical University of Vienna

Brief Summary:

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 or disease Intervention/treatment Phase
Atherosclerosis Procedure: primary stenting Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Balloon Angioplasty Versus Stenting With Nitinol Stents in the Superficial Femoral Artery
Study Start Date : June 2003
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Primary Outcome Measures :
  1. Angiographic restenosis at 6 months

Secondary Outcome Measures :
  1. restenosis by duplex ultrasound at 3,6 and 12 months
  2. walking distance on the treadmill at 3, 6 and 12 months
  3. ankle brachial index at 3, 6 and 12 months
  4. stent fractures at 6 and 12 months

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

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

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 identifier (NCT number): NCT00281060

Medical University Vienna
Vienna, Austria, A 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Martin Schillinger, MD Medical University Vienna

Publications of Results: Identifier: NCT00281060     History of Changes
Other Study ID Numbers: EK164/2003
First Posted: January 24, 2006    Key Record Dates
Last Update Posted: July 27, 2006
Last Verified: August 2005

Keywords provided by Medical University of Vienna:
balloon angioplasty

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases