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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
Sponsor:
Information provided by:
Medical University of Vienna

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Intermittent Claudication Atherosclerosis Angioplasty Procedure: angioplasty Phase 4

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
Study Start Date : June 2003
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)

Secondary Outcome Measures :
  1. occurence of restenosis within 6 months after endovascular treatment

Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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): NCT00437905


Sponsors and Collaborators
Medical University of Vienna
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00437905     History of Changes
Other Study ID Numbers: Version 2.0-12/2003
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: February 21, 2007
Last Verified: February 2007

Keywords provided by Medical University of Vienna:
peripheral vascular disease
percutaneous transluminal angioplasty
cutting balloon
balloon angioplasty
 randomized controlled trial
restenosis
inflammation

Additional relevant MeSH terms:
Atherosclerosis
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
 Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Signs and Symptoms