Trial of MiStent Compared to Xience in Japan

Coronary (Artery); Disease Clinical Trial

— DESSOLVEJ  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02972671
• Other study ID #: MIS-JPN-2016-05
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 28, 2016
• Est. completion date: April 30, 2022

Study information

• Verified date: September 2020
• Source: Micell Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Coronary (Artery); Disease
• Coronary Artery Disease
• Coronary Disease

Intervention

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
• 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

Locations

Country	Name	City	State
Japan	Kansai Rosai Hospital	Amagasaki-shi	Hyogo
Japan	Iwaki Municipal Iwaki Kyoritsu Hospital	Iwaki-shi	Fukushima
Japan	Tenyokai Central Hospital	Kagoshima-shi	Kagoshima
Japan	Saiseikai Yokohama Tobu Hospital	Kanagawa	Yokohama
Japan	Kanto Rosai Hospital	Kawasaki-shi	Kanagawa
Japan	Sinkoga Hospital	Kurume-shi	Kurume-shi, Fukuoka
Japan	Toho Univ.Ohashi Medical Center	Meguro-ku	Tokyo
Japan	Cardiovascular Institute Hospital	Minato-ku	Tokyo
Japan	Omihachiman Community Medical Center	Omihachiman-shi	Shiga
Japan	Shonan Kamakura General Hospital	Tokyo

Sponsors (3)

Lead Sponsor	Collaborator
Micell Technologies	Cardialysis BV, ClinLogix. LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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