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PVSS14. ePTFE Covered Spiral Nitinol Stents (aSpire) For SFA Disease

Karthik Kasirajan, David Rosenthal.
Emory University School of Medicine, Atlanta, Ga.

OBJECTIVES: To evaluate the safety and efficacy of using the aSpire (vascular Architects, Nashville, TN) ePTFE covered nitinol spiral stent for the treatment of superficial femoral artery (SFA) occlusive disease.

METHODS: Patients were prospectively entered into a percutaneous balloon/stent angioplasty registry for using the aSpire stent to treat occlusive disease of the SFA. Follow-up consisted of a Duplex ultrasound examinations at 3, 6 and 12 months. The end point was primary patency at 12-months. Overall, 39 different risk factors were evaluate for their association to primary patency. Wilcoxon rank sum was used for continuous variables and Chi-square for categorical variables. Significance level was 0.05.

RESULTS: 55 patients underwent SFA balloon/stent angioplasty with the aSpire stent. SFA lesion treated included TASC type A in 15 (27%), type B in 16 (29%), and type C or D lesions in 24 (44%). The mean lesion length was 89±104-mm. Primary stenting was performed in 24 patients, and the other patients had a pre-stent angioplasty. Majority of the patients had a single stent (66%) or two stents (18%). Post-stent angioplasty was performed in 49 (89%) of patients. The mean balloon inflation time (post-stent) was 113.07±62.43-seconds. The primary patency by life-table analysis at 12-months was 85.42%. Female gender (p=0.016), history of smoking (p=0.009), failure to perform a pre-stent angioplasty (p=0.007), longer lesion length (0.047), number of stents used (p=0.012), and lower balloon inflation times (p=0.008) were negatively associated with primary patency. The lesion type did not reach statistical significance (p=0.09).

CONCLUSIONS: The aSpire stent is a safe and effective stent for the treatment of SFA occlusive disease. Treating shorter lesion, performing pre-stent angioplasty and using longer balloon inflation times may help improve patency.