Results of the multicenter first-in-man study of a novel scoring balloon catheter for the treatment of infra-popliteal peripheral arterial disease.

Abstract

OBJECTIVE:

To evaluate the AngioSculpt (ASC), a novel scoring balloon catheter designed to treat complex diffuse fibro-calcific atherosclerotic lesions and avoid device slippage during deployment, in patients with infra-popliteal disease.

METHODS:

The ASC incorporates a flexible nitinol scoring element containing three or more spiral struts which encircle a minimally compliant balloon to create focal concentration of the dilating force. Patients scheduled for percutaneous intervention of infra-popliteal arteries or planned amputation and with a reference vessel diameter of 1.5-3.5 mm were included in the study.

RESULTS:

A total of 42 patients and 56 lesions were treated at five sites. Of these, 38 patients (90.5%) presented with critical limb ischemia (Rutherford Class > or = 4). The ASC was successfully deployed in 98.2% (55/56) of lesions attempted and was used as primary therapy without stenting in 89.3% (50/56). Lesion morphology was complex, including moderate/severe calcification in 73%, lesion length 33.9 +/- 42.2 mm, bifurcation in 26.8%, and ostial in 12.5%. There was no significant device slippage and no perforations. Post-ASC dissections occurred in only six (10.7%) lesions and were minor or resolved with stenting. In 13 patients initially referred for amputation, ASC treatment resulted in limb salvage.

CONCLUSIONS:

The ASC is highly effective in a broad range of complex lesion morphologies, in most cases as stand-alone therapy, is associated with a very low complication rate and avoids device slippage during deployment. Additional studies are planned to assess the long term efficacy of this promising new technology.

• Authors: Dierk Scheinert, Patrick Peeters, Marc Bosiers, Gerry O'Sullivan, Sherif Sultan, Gary Gershony
• Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions (Catheter Cardiovasc Interv) Vol. 70 Issue 7 Pg. 1034-9 (Dec 01 2007) ISSN: 1522-1946 [Print] United States
• PMID: 18044759 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
• Copyright: Copyright 2007 Wiley-Liss, Inc.

Chemical References

• Alloys
• nitinol

Topics

• Aged
• Aged, 80 and over
• Alloys
• Angioplasty, Balloon (instrumentation)
• Critical Illness
• Equipment Design
• Europe
• Female
• Humans
• Ischemia (etiology, pathology, therapy)
• Limb Salvage
• Male
• Peripheral Vascular Diseases (complications, pathology, therapy)
• Popliteal Artery (pathology)
• Prospective Studies
• Registries
• Research Design
• Severity of Illness Index
• Treatment Outcome