Trial of MiStent Compared to Xience in Japan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-28

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary (Artery); Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MiStent (MT005) Coronary Artery Stent

A balloon expandable crystalline sirolimus eluting stent with an absorbable polymer coating will be implanted.

Group Type EXPERIMENTAL

MiStent (MT005) Coronary Artery Stent

Intervention Type DEVICE

Implantation of a coronary artery stent 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

Xience Coronary Artery Stent

Balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating will be implanted

Group Type ACTIVE_COMPARATOR

Xience Coronary Artery Stent

Intervention Type DEVICE

Implantation of a coronary artery stent 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

Interventions

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MiStent (MT005) Coronary Artery Stent

Implantation of a coronary artery stent 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

Intervention Type DEVICE

Xience Coronary Artery Stent

Implantation of a coronary artery stent 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female patients ≥20 years;
* Patients who are eligible for percutaneous coronary intervention (PCI);
* 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;

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No