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

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   Angioplasty   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Balloon Angioplasty Versus Stenting With Nitinol Stents in the Superficial Femoral Artery

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  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 of Results:

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

Keywords provided by Medical University of Vienna:
endovascular  
balloon angioplasty  
stents  

Study placed in the following topic categories:
Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Arteriosclerosis

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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