Trial of MiStent Compared to Xience in Japan

NCT02972671 | Unknown DMC

• 1 other identifier: MIS-JPN-2016-05
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 10

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.

Conditions

Coronary (Artery); Disease

Keywords

MiStent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Target Lesion Revascularization (TLR)

  12 Months

• Target Vessel Myocardial Infarction (TV-MI)

  12 Months

• Cardiac Death

  12 Months

Study Arms (2)

MiStent (MT005) Coronary Artery Stent

EXPERIMENTAL

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

Device: MiStent (MT005) Coronary Artery Stent

Xience Coronary Artery Stent

ACTIVE COMPARATOR

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

Device: Xience Coronary Artery Stent

Interventions

MiStent (MT005) Coronary Artery Stent 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

MiStent (MT005) Coronary Artery Stent

Xience Coronary Artery Stent 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

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Micell Technologies: lead
• Cardialysis BV: collaborator
• ClinLogix. LLC: collaborator

Study Sites (10)

Iwaki Municipal Iwaki Kyoritsu Hospital

Iwaki, Fukushima, Japan

Location

Kansai Rosai Hospital

Amagasaki-shi, Hyōgo, Japan

Location

Tenyokai Central Hospital

Kagoshima, Kagoshima-ken, Japan

Location

Kanto Rosai Hospital

Kawasaki-shi, Kanagawa, Japan

Location

Sinkoga Hospital

Kurume-shi, Kurume-shi, Fukuoka, Japan

Location

Omihachiman Community Medical Center

Ōmihachiman, Shiga, 523-0082, Japan

Location

Toho Univ.Ohashi Medical Center

Meguro-ku, Tokyo, Japan

Location

Cardiovascular Institute Hospital

Minato-ku, Tokyo, Japan

Location

Saiseikai Yokohama Tobu Hospital

Kanagawa, Yokohama, Japan

Location

Shonan Kamakura General Hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Shigeru Saito, MD

  Shonan Kamakura General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 23, 2016
• Study Start: November 28, 2016
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2022
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (10)