Author(s): Peeters P, Bosiers M, Verbist J, Deloose K, Heublein B
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Abstract PURPOSE: To report the preliminary 3-month follow-up of a recently developed absorbable metal stent (AMS) for treatment of infrapopliteal lesions in patients with critical limb ischemia (CLI). METHODS: Between December 2003 and January 2004, 20 patients (10 men; mean age 76 years, range 59-96) with symptomatic critical limb ischemia (CLI) due to high-grade (80\% to 100\%) infrapopliteal stenoses received 1 or 2 AMS devices for suboptimal angioplasty. Clinical examination and color-flow duplex imaging were performed in all patients at discharge and at 1 and 3 months. RESULTS: Angiographic procedural success was achieved in all 20 patients. One patient died (non-procedure-related) during the periprocedural period. Three months after the procedure, primary clinical patency was 89.5\% (17/19). No major or minor amputation was necessary in any of the patients, yielding a limb salvage rate of 100\%. The average improvement in Rutherford class was 2.3 at the 3-month assessment. A comparison of postprocedural and 1-month color-flow duplex ultrasound and magnetic resonance images clearly indicated the ongoing absorption process of the AMS. CONCLUSIONS: After 3 months, the primary clinical patency and limb salvage rates suggest a potentially promising performance of these AMS devices in the treatment of below-knee lesions in CLI patients.
This article was published in J Endovasc Ther
and referenced in Journal of Biotechnology & Biomaterials