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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00281060
First received: January 20, 2006
Last updated: July 26, 2006
Last verified: August 2005
History of Changes
  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 4

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:

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:

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 June 18, 2013