Trial of MiStent Compared to Xience in Japan

Study Overview
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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.

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.

Official Title
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Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MT005) for Revascularization of Coronary Arteries

Conditions
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Coronary (Artery); Disease

Intervention / Treatment
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* Device: MiStent (MT005) Coronary Artery Stent
* Device: Xience Coronary Artery Stent


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MiStent (MT005) Coronary Artery Stent<br>A balloon expandable crystalline sirolimus eluting stent with an absorbable polymer coating will be implanted. | Device: MiStent (MT005) Coronary Artery Stent<br>* 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<br>|
| Active Comparator: Xience Coronary Artery Stent<br>Balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating will be implanted | Device: Xience Coronary Artery Stent<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF)-Composite of Target Lesion Revascularization (TLR), Target Vessel MI (TV MI), and Cardiac Death | The proportion of patients in each arm that experience TLF will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Revascularization (TLR) | The proportion of patients in each arm that experience TLR will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure. | 12 Months | 
| Target Vessel Myocardial Infarction (TV-MI) | The proportion of patients in each arm that experience TV-MI will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure. | 12 Months | 
| Cardiac Death | The proportion of patients in each arm that experience Cardiac Death will be summarized and reported. No formal comparison of the two arms will be conducted. Portions will be reported at 12 months post procedure. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MiStent