October 9, 2013—An update to the ESPIRIT I trial was presented by Johannes Lammer, MD, at the VIVA 2013: Vascular Interventional Advances conference on October 8–11 in Las Vegas, Nevada.
The ESPRIT I trial evaluated the safety and performance of the Esprit BVS bioresorbable vascular scaffold system (Abbott Vascular, Santa Clara, CA) in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral artery (SFA) or common or external iliac arteries. The ESPIRIT I trial is a prospective, single-arm, open-labeled, multicenter clinical investigation in which 35 subjects received the study device at seven European centers. Subjects receive clinical and hemodynamic follow-up at 1, 6, and 12 months and at 2 and 3 years, and angiographic follow-up at 12 months. One subject withdrew consent for follow-up, so follow-up is ongoing with 34 subjects.
The subjects were predominantly male (77.1%), with a high incidence of dyslipidemia (85.7%), hypertension (71.4%), and tobacco use (82.9%). Lesions treated were predominantly located in the SFA (88.6%), and lesion length averaged 35.5 mm. Total occlusions occurred in 22.9% of cases; in those cases, the occlusion length averaged 30.6 mm. Acute success was 100%; in all cases, investigators were able to use the device without difficulty.
Preprocedure in-segment percent diameter stenosis was 80%. Excellent acute angiographic results were achieved, with postprocedure in-segment percent diameter stenosis averaging 13.1%. This was consistent with the postprocedure duplex peak systolic velocity ratio (PSVR) of 1.27. The duplex assessments at 1 month and 6 months continued to show widely patent arteries, with observed PSVR of 1.26 and 1.35, respectively.
The investigators concluded that angiography and duplex ultrasound showed widely patent arteries after treatment with Esprit BVS, sustained to 6 months with a restenosis rate of 0% on duplex. The imaging results show no indication of acute or delayed scaffold recoil. Follow-up is ongoing, with angiography and duplex ultrasound scheduled at 12 months.
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