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PTA vs. CB-PTA for Treatment of Femoropopliteal Artery In-Stent Restenosis

This study has been completed.
Information provided by:
Vienna General Hospital Identifier:
First received: June 1, 2007
Last updated: September 10, 2007
Last verified: May 2007
Percutaneous transluminal angioplasty (PTA) is a minimally invasive technique for treatment of superficial femoropopliteal artery (SFA) obstructions or occlusions in patients with intermittent claudication as well as critical limb ischemia. Initial technical success rates of above 95% can be achieved and acceptably low rates of complications are consistently reported in the literature. There is a direct relation between treated vessel length and patency rates. One year patency of lesions longer than 10cm has only been 22% at one-year follow up. This major drawback limits a widespread applicability of PTA, and the indication of PTA particularly in patients with intermittent claudication is discussed controversially.With the introduction of endovascular stents, the problems of elastic recoil and residual stenoses due to arterial dissection could be resolved and initial reports of stenting for the treatment of occlusive atherosclerotic disease of the SFA showed promising results with primary and secondary patency rates of 87% to 90% after 18 months. However, subsequent studies demonstrated that exaggerated neo-intimal hyperplasia in the stented segment frequently leads to instent restenosis. This condition will be of greater importance with increasing number of stent implantation procedures during the last years. The concept of cutting balloon seems appealing for this indication, as the balloon-mounted microtomes guarantee smooth lumen gain within the stent, without the risk of vessel wall perforation. Initial reports of the use of the cutting balloon for the treatment of occlusive atherosclerotic disease of the SFA show promising results, indicating that the problems of elastic recoil and residual stenoses due to arterial dissection might be resolved. The cutting balloon has four tiny microtomes (< 0.1mm height) on the outside, which cut the fibrous plaque during expansion of the balloon. Consequently the problem of elastic recoil is ideally addressed, additionally less trauma is exercised on the vessel wall during dilatation of the balloon. This might be achieved by a reduction of vessel wall trauma, vessel wall inflammation and consequently reduced neointimal formation. Although the indications for CB-PTA in the SFA includes significant residual stenosis or in-stent restenosis, there are currently no published randomized controlled trials (RCT) comparing PTA vs. cutting balloon angioplasty (CB-PTA) for any specific condition. This lack of data led us to initiate a RCT comparing primary PTA vs. CB-PTA for treatment of in-stent restenoses in patients with intermittent claudication or critical limb ischemia with TASC category A-B in the femoropopliteal artery .

Condition Intervention
Instent Restenosis Cutting Balloon Angioplasty Device: plain balloon angioplasty Device: cutting balloon angioplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conventional Balloon Angioplasty vs. Cutting Balloon Angioplasty for Treatment of Femoropopliteal Artery In-Stent Restenosis - A Randomized Controlled Pilot Trial

Resource links provided by NLM:

Further study details as provided by Vienna General Hospital:

Primary Outcome Measures:
  • The primary study endpoint is the occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by duplex ultrasound (in-segment restenosis) [ Time Frame: within 6 months follow up ]

Secondary Outcome Measures:
  • primary technical success rates residual stenosis <30% without need for secondary stent implantation, primary assisted and secondary patency, clinical patency, target vessel and target lesion revascularization, cardiovascular adverse events [ Time Frame: within 6 months follow up ]

Enrollment: 40
Study Start Date: November 2004
Estimated Study Completion Date: April 2007
  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with in-stent restenosis (ultrasonographic stenosis > 50% of the vessel lumen diameter) after prior PTA and Stent placement of the SFA
  • symptomatic peripheral artery disease with intermittent claudication or critical limb ischemia

Exclusion Criteria:

  • history of intolerance of anti-platelet therapy
  • adverse reaction to heparin
  • bleeding diathesis
  • creatinine >2.5 mg/dL
  • hemodialysis
  • active bacterial infection
  • allergy to contrast media
  • pregnancy
  • disability to give informed consent
  Contacts and Locations
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Please refer to this study by its identifier: NCT00481780

General Hospital of Vienna
Vienna, Austria
Sponsors and Collaborators
Vienna General Hospital
Principal Investigator: Minar Erich, Prof.Dr. General Hospital of Vienna
  More Information Identifier: NCT00481780     History of Changes
Other Study ID Numbers: 2004
Study First Received: June 1, 2007
Last Updated: September 10, 2007 processed this record on July 21, 2017