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

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00437905

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 IV

MedlinePlus related topics: Angioplasty Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial

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

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

Publications indexed to this study:

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. Epub 2008 Feb 12.

Study ID Numbers:	Version 2.0-12/2003
Study First Received:	February 20, 2007
Last Updated:	February 20, 2007
ClinicalTrials.gov Identifier:	NCT00437905
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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Signs and Symptoms
Peripheral Vascular Diseases

Vascular Diseases
Intermittent Claudication
Arteriosclerosis
Inflammation

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009