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

NCT00437905 | Terminated Phase 4

• 1 other identifier: Version 2.0-12/2003
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Vascular Disease; Intermittent Claudication; Atherosclerosis; Angioplasty

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• occurence of restenosis within 6 months after endovascular treatment

Interventions

angioplasty PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe intermittent claucication (Fontaine stage IIb)or limb ischemia, femoropoliteal stenosis/occlusion up to 5 cm length

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Related Publications (1)

• 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.

  PMID: 18270378 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Intermittent Claudication; Atherosclerosis; Inflammation

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 21, 2007
• Study Start: June 1, 2003
• Study Completion: January 1, 2007
• Last Updated: February 21, 2007

Record last verified: 2007-02