Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00437905 |
Recruitment Status :
Terminated
First Posted : February 21, 2007
Last Update Posted : February 21, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Vascular Disease Intermittent Claudication Atherosclerosis Angioplasty | Procedure: angioplasty | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial |
Study Start Date : | June 2003 |
Study Completion Date : | January 2007 |
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 |
First Posted: | February 21, 2007 Key Record Dates |
Last Update Posted: | February 21, 2007 |
Last Verified: | February 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 Intermittent Claudication Peripheral Vascular Diseases Peripheral Arterial Disease |
Arteriosclerosis Arterial Occlusive Diseases Cardiovascular Diseases Signs and Symptoms |