Back to results

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

Primary Purpose

Peripheral Vascular Disease, Intermittent Claudication, Atherosclerosis

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

angioplasty

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring peripheral vascular disease, percutaneous transluminal angioplasty, cutting balloon, balloon angioplasty, randomized controlled trial, restenosis, inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

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

Full Information

NCT ID

NCT00437905

First Posted

February 20, 2007

Last Updated

February 20, 2007

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00437905

Brief Title

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

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Terminated

Study Start Date

June 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Disease, Intermittent Claudication, Atherosclerosis, Angioplasty

Keywords

peripheral vascular disease, percutaneous transluminal angioplasty, cutting balloon, balloon angioplasty, randomized controlled trial, restenosis, inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

angioplasty

Primary Outcome Measure Information:

Title

course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)

Secondary Outcome Measure Information:

Title

occurence of restenosis within 6 months after endovascular treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jasmin Amighi, MD

Organizational Affiliation

Medical University of Vienna

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Martin Schillinger, MD

Organizational Affiliation

Medical University of Vienna

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Manfred Cejna, MD

Organizational Affiliation

Medical University of Vienna

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

18270378

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs