Angioplasty, Atherosclerosis, Intermittent Claudication, Peripheral Vascular Disease
Conditions
Keywords
peripheral vascular disease, percutaneous transluminal angioplasty, cutting balloon, balloon angioplasty, randomized controlled trial, restenosis, inflammation
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.
Interventions
PROCEDUREangioplasty
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP) | — |
Secondary
| Measure | Time frame |
|---|---|
| occurence of restenosis within 6 months after endovascular treatment | — |
Outcome results
None listed