Clinical Trials
DESSOLVE I Clinical Trial
Micell has an ongoing clinical study, DESSOLVE I in New Zealand, Australia and Belgium. DESSOLVE I (DES with Sirolimus and a absorbable pOLymer for the treatment of patients with de noVo lEsions in the native coronary arteries), a first-in-human clinical trial of the company’s investigational MiStent Drug Eluting Coronary Stent System (MiStent DES).
DESSOLVE I is a prospective, open-label, non-randomized, single-arm study that is expected to enroll 30 patients at five clinical sites in Belgium, Australia and New Zealand. Candidates for the trial are patients with documented stable or unstable angina pectoris or ischemia. The primary endpoint is in-stent late lumen loss, as measured with angiography in treated de novo lesions ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 23 mm long stent.
Along with secondary clinical endpoints such as major adverse cardiac events and revascularization rates, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) will also be employed at multiple timepoints. The DESSOLVE I study uses multiple imaging modalities to better understand the time to complete tissue coverage of the stent struts relative to polymer absorption.
More information on the DESSOLVE I trial can be found here.
DESSOLVE II Clinical Trial
DESSOLVE II is a prospective, controlled, 2:1 unbalanced randomized, multi-center study consisting of 183 patients. Patients have been enrolled at 26 clinical sites in Europe and New Zealand. The trial includes patients with documented stable or unstable angina pectoris or ischemia. The primary endpoint is superiority of MiStent DES in minimizing in-stent late lumen loss at nine months, compared to Medtronic's Endeavor® DES, as measured with angiography in treated de novo lesions ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 30 mm long stent.
Along with secondary clinical endpoints such as major adverse cardiac events and revascularization rates, the extent of stent coverage and re-endothelialization, via optical coherence tomography (OCT), and endothelial function (vasomotor response) will be evaluated in a subgroup of patients at nine months. More information on the DESSOLVE II trial can be found here.
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