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Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT00437905
Recruitment Status : Terminated
First Posted : February 21, 2007
Last Update Posted : February 21, 2007
Information provided by:
Medical University of Vienna

February 20, 2007
February 21, 2007
February 21, 2007
June 2003
Not Provided
course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)
Same as current
No Changes Posted
occurence of restenosis within 6 months after endovascular treatment
Same as current
Not Provided
Not Provided
Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
The purpose of this study to compare balloon angioplasty (PTA) vs. cutting balloon angioplasty (CB-PTA) in terms of patency and postintervention inflammation in peripheral artery disease.

Balloon Angioplasty is a minimal invasive technique for treatment of superficial femoropoliteal artery obstructions. Despite high initial success rate and an acceptably low complication rate, long-term-results are disappointing as restenosis may frequently occur. One of the hypothesis for the differences in the reported patency rates is that the amount of vessel trauma correlates directly to the prognosis (restenosis) of the treated vessel wall segment.

With the introduction of cutting balloons the problems of elastic recoil and residual stenosis might be resolved, by reduction of vessel wall trauma, vessel wall inflammation and consequently reduced neointima formation.

The promising results especially in coronary arteries led us to initiate a RCT comparing primary PTA vs. CB-PTA for treatment of femoropoliteal obstructions in patients with intermittent claudication or critical limb ischemia.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Peripheral Vascular Disease
  • Intermittent Claudication
  • Atherosclerosis
  • Angioplasty
Procedure: angioplasty
Not Provided
Amighi J, Schillinger M, Dick P, Schlager O, Sabeti S, Mlekusch W, Haumer M, Mathies R, Heinzle G, Schuster A, Loewe C, Koppensteiner R, Lammer J, Minar E, Cejna M. De novo superficial femoropopliteal artery lesions: peripheral cutting balloon angioplasty and restenosis rates--randomized controlled trial. Radiology. 2008 Apr;247(1):267-72. doi: 10.1148/radiol.2471070749. Epub 2008 Feb 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2007
Not Provided

Inclusion Criteria:

  • Severe intermittent claucication (Fontaine stage IIb)or limb ischemia, femoropoliteal stenosis/occlusion up to 5 cm length

Exclusion Criteria:

  • Previous bypass surgery at the site of treatment,
  • Previous stent placement at or immediatly adjacent to target lesion,
  • History of anti-platelet-therapy intolerance or adverse reaction to heparin,
  • Bleeding diathesis,
  • Creatinine > 2,5 mg/dL,
  • Active bacterial infection,
  • Allergy to contrast media
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Version 2.0-12/2003
Not Provided
Not Provided
Not Provided
Not Provided
Medical University of Vienna
Not Provided
Principal Investigator: Jasmin Amighi, MD Medical University of Vienna
Principal Investigator: Martin Schillinger, MD Medical University of Vienna
Principal Investigator: Manfred Cejna, MD Medical University of Vienna
Medical University of Vienna
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP