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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00281060
First Posted: January 24, 2006
Last Update Posted: July 27, 2006
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.
Information provided by:
Medical University of Vienna
  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
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 20, 2006
First Posted: January 24, 2006
Last Update Posted: July 27, 2006
Last Verified: August 2005

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

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