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International trial to test BVS in critical limb ischemia
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The ABSORB BTK trial, which will evaluate the bioresorbable vascular scaffold in patients with below-the-knee critical limb ischemia, has begun enrolling patients, according to a press release issued by the manufacturer.
The bioresorbable vascular scaffold (BVS; Absorb, Abbott) is made of a biocompatible material, polylactide, that helps restore naturally occurring vessel function without leaving a permanent metallic implant behind, the release said. Although not available for sale in the United States, the BVS received CE mark approval in January for the treatment of CAD.
In the prospective, single-arm, multicenter ABSORB BTK trial, investigators will look at the BVS in up to 90 patients with below-the-knee critical limb ischemia at up to 10 clinical trial sites in Europe and New Zealand. The study’s primary endpoint will be a composite of freedom from major adverse limb events at 1 year or death within 30 days of the procedure.
The study follows the ABSORB trial, which tested the BVS in patients with CAD, and the ABSORB EXTEND trial, which is currently being conducted and will also evaluate the device in patients with CAD.