This article is more than 5 years old. Information may no longer be current.
XCELL: Encouraging Results Published on Novel Device for Treating CLI
Click Here to Manage Email Alerts
A new device for the treatment of critical limb ischemia was shown to be safe and effective at 12 months, according to results of the XCELL trial.
The study, which was published in Catheterization and Cardiovascular Interventions, included 120 patients (140 limbs, 212 implanted devices) from a multicenter registry who had Rutherford class 4, 5 or 6 critical limb ischemia. All patients were treated with a self-expanding nitinol stent (Xpert, Abbott Vascular) and underwent primary infrapopliteal stent deployment.
At 12 months, the amputation-free survival (AFS) rate, the study’s primary endpoint, was 78.3%, despite a 6-month binary stent restenosis rate of 68.5%. When researchers stratified patients by Rutherford class, they found AFS rates of 100% in class 4 patients, 77.3% in class 5 and 55.2% in class 6, and freedom from major amputation rates of 100% in class 4, 90.9% in class 5 and 70.1% in class 6 patients.
Also at 12 months, the following rates were observed: 89.6% freedom from amputation; 70.1% freedom from clinically driven target lesion revascularization; and 54.4% complete wound healing.
According to Krishna J. Rocha-Singh, MD, study investigator, the stent was used as part of a physician investigational device exemption and is approved for use as a biliary stent.
For more information:
Rocha-Singh KJ. Catheter Cardiovasc Interv. 2012;doi:10.1002/ccd.24485.
Disclosure: Dr. Rocha-Singh is a member of the board of directors for VIVA Physicians, a 501(c)(3) nonprofit physician education and research organization.
Perspective
Back to Top
J.P. Reilly, MD, FACC, FSCAI
This study examines those most significantly affected by peripheral arterial disease: patients with non-healing ulcers and those at risk for losing their limbs. Dr. Rocha-Singh and colleagues demonstrate that endovascular therapy with stenting is an appropriate choice for patients with critical limb ischemia (CLI).
Ultimately, I believe that the Xpert stent can play a role in the treatment of CLI in the future because stenting provides more durable results than angioplasty alone. As a registry, these data do not inform us about the effectiveness of the Xpert stent compared with other devices, but the clinical results of these data are encouraging.
Click Here to Manage Email Alerts