Results of the multicenter first-in-man study of a novel scoring balloon catheter for the treatment of infra-popliteal peripheral arterial disease.
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.
Scheinert
Dierk
D
Department of Angiology, Leipzig Heart Center, Leipzig, Germany.
Peeters
Patrick
P
Bosiers
Marc
M
O'Sullivan
Gerry
G
Sultan
Sherif
S
Gershony
Gary
G
D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000800:Angioplasty, Balloon / Q000295:instrumentation*; D016638:Critical Illness; D004867:Equipment Design; D005060:Europe; D005260:Female; D006801:Humans; D007511:Ischemia / Q000209:etiology* / Q000473:pathology / Q000628:therapy; D023821:Limb Salvage; D008297:Male; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000473:pathology / Q000628:therapy*; D011150:Popliteal Artery / Q000473:pathology; D011446:Prospective Studies; D012042:Registries; D012107:Research Design; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000497:Alloys; C013616:nitinol