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

This study has been terminated.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00437905
First received: February 20, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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 Intervention Phase
Peripheral Vascular Disease
Intermittent Claudication
Atherosclerosis
Angioplasty
Procedure: angioplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)

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

Estimated Enrollment: 40
Study Start Date: June 2003
Estimated Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Medical University of Vienna

Additional 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
Study First Received: February 20, 2007
Last Updated: February 20, 2007
Health Authority: Austria: Federal Ministry for Health and Women

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
Intermittent Claudication
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014