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news.MIV Therapeutics has announced that the first patients have been enrolled in the registration trial of its VESTAsync polymer-free drug-eluting stent.
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In this 120-patient, multi-center, randomized, controlled study 90 patients will receive the VESTAsync nano-porous hydroxyapatite (HAp) coated drug-eluting stent, while 30 patients will receive the company’s VESTAcor stent, the company’s nano-porous HAp coated stent, which contains no drug.
The primary endpoint is late lumen loss as measured by quantitative coronary angiography at nine months. Secondary endpoints will include major adverse cardiac events and volumetric obstruction. Intravascular ultrasound, optical coherent tomography and physiological sub studies are also expected to be performed.
Mark Landy, president and CEO of MIV Therapeutics, said: “We are accelerating this registration trial due to the results obtained with the VESTAsync in our pilot study after nine-month patient follow up, and the potential to address safety issues in currently marketed drug-eluting stents using polymers to deliver drug.”