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.
Department of Angiology, Leipzig Heart Center, Leipzig, Germany.
Dierk
D
Scheinert
Patrick
P
Peeters
Marc
M
Bosiers
Gerry
G
O'Sullivan
Sherif
S
Sultan
Gary
G
Gershony
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