Trial of MiStent Compared to Xience in Japan

Not Applicable

• Conditions: Coronary (Artery); Disease
• Interventions: Device: Xience Coronary Artery Stent; Device: MiStent (MT005) Coronary Artery Stent

• Registration Number: NCT02972671
• Lead Sponsor: Micell Technologies

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-23
• Study Start: 2016-11-28
• Primary Completion: 2018-04-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xience Coronary Artery Stent	Xience Coronary Artery Stent	Balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating will be implanted
MiStent (MT005) Coronary Artery Stent	MiStent (MT005) Coronary Artery Stent	A balloon expandable crystalline sirolimus eluting stent with an absorbable polymer coating will be implanted.

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)-Composite of Target Lesion Revascularization (TLR), Target Vessel MI (TV MI), and Cardiac Death	12 Months	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.

Secondary Outcome Measures

Name	Time	Method
Target Vessel Myocardial Infarction (TV-MI)	12 Months	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.
Target Lesion Revascularization (TLR)	12 Months	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.
Cardiac Death	12 Months	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.

Trial Locations

Locations (10)

Saiseikai Yokohama Tobu Hospital; 🇯🇵 Kanagawa, Yokohama, Japan

Shonan Kamakura General Hospital; 🇯🇵 Tokyo, Japan

Toho Univ.Ohashi Medical Center; 🇯🇵 Meguro-ku, Tokyo, Japan

Iwaki Municipal Iwaki Kyoritsu Hospital; 🇯🇵 Iwaki-shi, Fukushima, Japan

Kansai Rosai Hospital; 🇯🇵 Amagasaki-shi, Hyogo, Japan

Tenyokai Central Hospital; 🇯🇵 Kagoshima-shi, Kagoshima, Japan

Cardiovascular Institute Hospital; 🇯🇵 Minato-ku, Tokyo, Japan

Kanto Rosai Hospital; 🇯🇵 Kawasaki-shi, Kanagawa, Japan

Sinkoga Hospital; 🇯🇵 Kurume-shi, Kurume-shi, Fukuoka, Japan

Omihachiman Community Medical Center; 🇯🇵 Omihachiman-shi, Shiga, Japan