Trial of MiStent Compared to Xience in Japan
Trial of MiStent Compared to Xience in Japan
To compare the MT005 (MiStent) with the XIENCE with respect to target lesion failure (TLF) at
 12 months in a non-inferiority trial in a "real world" patient population and to confirm that
 the domestic extrapolation of the DESSOLVE III study results is valid.
This is a prospective, randomized, 1:1 balanced, controlled, double-blind, multi-center study
 comparing clinical outcomes at 12 months between MT005 (MiStent) and XIENCE in an all-comers
 population, including patients with symptomatic coronary artery disease including patients
 with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for
 percutaneous coronary interventions.
Inclusion Criteria:

 -  Male or female patients ≥20 years;

 -  Patients who are eligible for percutaneous coronary intervention (PCI);

 -  The vessel should have a reference vessel diameter ranging from 2.5 mm to 3.75 mm. All
 lesions of the patient must comply with the angiographic inclusion criteria and no
 more than 4 stents per patient are to be implanted.

 -  The patient is judged to be capable of providing voluntary informed consent and has
 been fully informed of the nature of the study, is willing to comply with all study
 requirements and will provide written informed consent as approved by the Ethics
 Committee of the respective clinical site.

 Exclusion Criteria:

 -  Known pregnancy or breastfeeding at time of randomization or planned pregnancy for 12
 months after the index treatment. Women of childbearing potential must have a negative
 pregnancy test within 7 days of randomization;

 -  Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium,
 or to medications such as aspirin, heparin, bivalirudin, and all of the following
 three medications: clopidogrel bisulfate, ticlopidine, prasugrel;

 -  Concurrent medical condition with a life expectancy of less than 12 months;

 -  The patient is unwilling/not able to return for outpatient clinic at 1, 6 and 12
 months follow-up;

 -  Currently participating in another trial and not yet at its primary endpoint;