Trial of MiStent Compared to Xience in Japan (DESSOLVEJ)

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary (Artery); Disease
• Intervention / Treatment: Device: MiStent (MT005) Coronary Artery Stent; Device: Xience Coronary Artery Stent

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Shonan Kamakura General Hospital
  • Fukushima
    • Iwaki-shi, Fukushima, Japan
      • Iwaki Municipal Iwaki Kyoritsu Hospital
  • Hyogo
    • Amagasaki-shi, Hyogo, Japan
      • Kansai Rosai Hospital
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan
      • Tenyokai Central Hospital
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan
      • Kanto Rosai Hospital
  • Kurume-shi, Fukuoka
    • Kurume-shi, Kurume-shi, Fukuoka, Japan
      • Sinkoga Hospital
  • Shiga
    • Omihachiman-shi, Shiga, Japan, 523-0082
      • Omihachiman Community Medical Center
  • Tokyo
    • Meguro-ku, Tokyo, Japan
      • Toho Univ.Ohashi Medical Center
    • Minato-ku, Tokyo, Japan
      • Cardiovascular institute hospital
  • Yokohama
    • Kanagawa, Yokohama, Japan
      • Saiseikai Yokohama tobu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Micell Technologies
• Collaborators: Cardialysis BV; ClinLogix. LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2016
• Primary Completion (Actual): April 30, 2018
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: MiStent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Coronary Disease
• Other Study ID Numbers: MIS-JPN-2016-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No