Clinical trial NCT00437905: Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
Official title: Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Peripheral Vascular Disease
Intermittent Claudication
Atherosclerosis
Angioplasty
Keywords: peripheral vascular disease
percutaneous transluminal angioplasty
cutting balloon
balloon angioplasty
randomized controlled trial
restenosis
inflammation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)
Secondary outcomes:
measure: occurence of restenosis within 6 months after endovascular treatment
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Jasmin Amighi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Martin Schillinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Manfred Cejna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.