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Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Peripheral Vascular Disease Intermittent Claudication Atherosclerosis Angioplasty | Procedure: angioplasty | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 |
- course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)
- occurence of restenosis within 6 months after endovascular treatment
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | January 2007 |
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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00437905
| 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 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 |
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 |
ClinicalTrials.gov processed this record on July 24, 2017