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New angioplasty procedure improves blood flow in blocked arteries to extremities
Date:7/24/2012

TM Nitinol Stenting For Critically IschEmic Lower Limbs" (XCELL) evaluates the safety and effectiveness of this device in patients with CLI. The Xpert stent is manufactured by Abbott, a global health care company. The device was evaluated in 120 CLI patients with infrapopliteal lesions of 4-15 cm in length. A total of 140 limbs and 212 implanted devices were included in the study, with 12-month amputation-free survival (AFS), limb salvage, wound healing and pain relief determining the success of the procedure.

Results reveal that 12-month AFS was 78%. Further analysis confirmed that according to baseline Rutherford classes 4, 5, and 6, the 12-month AFS rates were 100%, 77%, 55%, respectively; freedom from major amputation were 100%, 91% and 70%, respectively. The investigators also determined that the 12-month freedom from major amputation rate and clinically driven target lesion revascularization were 90% and 70%, respectively. Six-month and 12-month wound-healing rates were 49% and 54%, respectively. Moreover, Rutherford class 4 patients had significant pain relief through 12 months.

"Our XCELL trial findings confirm that infrapopliteal nitinol stenting is safe and effective in treating CLI patients," concludes Dr. Rocha-Singh. "While there were a few major adverse events, such as death, heart attack, or major amputation that occurred in the first 30 days, at the first year post-procedure, limb preservation, wound healing and pain relief rates were excellent." The authors also point out that the 12-month wound healing with nitinol stenting was similar to the more invasive open surgery.


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Contact: Dawn Peters
sciencenewsroom@wiley.com
781-388-8408
Wiley
Source:Eurekalert

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