Clinical trial NCT02972671: Trial of MiStent Compared to Xience in Japan
Official title: Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MT005) for Revascularization of Coronary Arteries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary (Artery); Disease
Keywords: MiStent
Lead sponsor: Micell Technologies
Sponsor class: INDUSTRY
Collaborators: name: Cardialysis BV
name: ClinLogix. LLC
First posted: 2016-11-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Target Lesion Failure (TLF)-Composite of Target Lesion Revascularization (TLR), Target Vessel MI (TV MI), and Cardiac Death
timeFrame: 12 Months
Secondary outcomes:
measure: Target Lesion Revascularization (TLR)
timeFrame: 12 Months
measure: Target Vessel Myocardial Infarction (TV-MI)
timeFrame: 12 Months
measure: Cardiac Death
timeFrame: 12 Months
Other outcomes:
Locations:
city: Iwaki-shi
country: Japan
facility: Iwaki Municipal Iwaki Kyoritsu Hospital
state: Fukushima
city: Amagasaki-shi
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Kagoshima-shi
country: Japan
facility: Tenyokai Central Hospital
state: Kagoshima
city: Kawasaki-shi
country: Japan
facility: Kanto Rosai Hospital
state: Kanagawa
city: Kurume-shi
country: Japan
facility: Sinkoga Hospital
state: Kurume-shi, Fukuoka
city: Omihachiman-shi
country: Japan
facility: Omihachiman Community Medical Center
state: Shiga
city: Meguro-ku
country: Japan
facility: Toho Univ.Ohashi Medical Center
state: Tokyo
city: Minato-ku
country: Japan
facility: Cardiovascular Institute Hospital
state: Tokyo
city: Kanagawa
country: Japan
facility: Saiseikai Yokohama Tobu Hospital
state: Yokohama
city: Tokyo
country: Japan
facility: Shonan Kamakura General Hospital
Study officials:
affiliation: Shonan Kamakura General Hospital
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
References: