The MiStent SES has received CE marking but is not approved in the USA or any other countries.
The following clinical trials are currently in long term follow-up. The 2 year follow-up for both trials was completed in 2013.
DESSOLVE I Clinical Trial
Micell has an ongoing clinical study, DESSOLVE I in New Zealand, Australia and Belgium. DESSOLVE I (MiStent SES with sirolimus and an 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® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES).
DESSOLVE I is a prospective, open-label, non-randomized, single-arm study that has enrolled 30 patients at five clinical sites in Belgium, Australia and New Zealand. Candidates for the trial had documented stable or unstable angina pectoris or ischemia. The primary endpoint, in-stent late lumen loss, was 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) were also employed at multiple time points. The DESSOLVE I study used 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 SES 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.
DESSOLVE III Post Market Clinical Trial
Micell, in conjunction with Stentys has an ongoing randomized, controlled trial (RCT) of the MiStent SES in Europe. This study is a prospective, randomized, balanced, controlled, single-blind, multi-center study comparing clinical outcomes at 12 months between MiStent and XienceŽ in a real world, all-comers patient population (patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions). Enrollment will include 1,400 patients randomized to MiStent SES or Xience at approximately 17 sites in Europe. The primary endpoint for this trial is a non-inferiority comparison of a device-oriented composite endpoint (DOCE) or target lesion failure (TLF) of the MiStent SES group to the Xience group at 12 months post-procedure. TLF is a composite of cardiac death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization (TLR).
DESSOLVE III also will include an optical coherence tomography (OCT) sub-study evaluation of 60 patients (30 MiStent SES, 30 Xience) at six and 24 months post-treatment to evaluate and compare for superiority of MiStent SES against Xience in the progression of in-stent percent volume obstruction and frequency of neoatheroma formation over time.
More information on the DESSOLVE III trial can be found here