Trial of MiStent Compared to Xience in Japan (DESSOLVEJ)

Micell Technologies

Status

Unknown

Conditions

Coronary (Artery); Disease

Treatments

Device: Xience Coronary Artery Stent

Device: MiStent (MT005) Coronary Artery Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT02972671

MIS-JPN-2016-05

Details and patient eligibility

About

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.

Full description

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.

Enrollment

120 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

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;