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Home > Press Center > Stent Shows Promise in Treatment

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Jill Goodwin
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312-334-2308

The use of the aSpire™ nitinol self-expandable polytetrafluoroethylene covered stent for the treatment of long lesions of the superficial femoral arteries (SFAs) has been deemed safe, according to a study presented at the 60th Annual Meeting of the Society for Vascular Surgery. 

“Longer lesions (of more than three centimeters) are often found in patients with femoro-popliteal obstruction,” said lead author Massimo Lenti, MD, from the vascular surgery unit of the University of Perugia in Perugia, Italy. “Endovascular therapy with this particular stent has the potential to improve symptoms and the quality of life to prevent limb amputation. The data we collected on 162 procedures from a 16-center registry indicated initial 96.5 percent technical success. Success was measured when vessel recanalization with residual stenosis less than 30 percent and the stent showed patency.”

Twenty-five patients suffered complications from the procedure including six peripheral embolizations, seven thromboses, three hemorrhages, two vessel ruptures and seven vessel dissections. Dr. Lenti added that 31 reinterventions (frequently percutaneous) had to be performed to attain an optimal assisted primary patency.  Sixteen cases were managed with a catheter, while 15 patients had to have surgery. 

Dr. Lenti and his co-authors evaluated the results of 168 limbs for lesions of more than three centimeters. There were 118 occlusions, 50 cases of stenosis of the SFA and 115 of the proximal popliteal arteries. Ninety-two procedures were performed for intermittent claudication, 34 for rest pain and 42 for limb savage (five ended in amputation.)

“Ninety-two procedures were performed and 39 of them required more than one stent; the total number of stents was 216,” said Dr. Lenti. “In 99 cases femoral surgical access was required for stent placement and in 11, debulking techniques were necessary.” Dr. Lenti added that a multivariate analysis of critical limb ischemia was the only significant predictor of late failure in the SFA patients.  

“A clinical and ultrasound evaluation was done at discharge, one month, six months, a year and annually thereafter,” said Dr. Lenti. “These are mid-term results, so although use of the aSpire™ stent appears to be safe, further evaluation of clinical outcomes at a longer follow-up, as well as technological and pharmalogical improvements, are warranted to better define the applications of the device,” said Dr. Lenti.