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| Name | Class |
|---|---|
| Cardialysis BV | INDUSTRY |
| ClinLogix. LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MiStent (MT005) Coronary Artery Stent | Experimental | A balloon expandable crystalline sirolimus eluting stent with an absorbable polymer coating will be implanted. |
|
| Xience Coronary Artery Stent | Active Comparator | Balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating will be implanted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shigeru Saito, MD | Shonan Kamakura General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iwaki Municipal Iwaki Kyoritsu Hospital | Iwaki | Fukushima | Japan | |||
| Kansai Rosai Hospital |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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 |
|
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 |
| Amagasaki-shi |
| Hyōgo |
| Japan |
| Tenyokai Central Hospital | Kagoshima | Kagoshima-ken | Japan |
| Kanto Rosai Hospital | Kawasaki-shi | Kanagawa | Japan |
| Sinkoga Hospital | Kurume-shi | Kurume-shi, Fukuoka | Japan |
| Omihachiman Community Medical Center | Ōmihachiman | Shiga | 523-0082 | Japan |
| Toho Univ.Ohashi Medical Center | Meguro-ku | Tokyo | Japan |
| Cardiovascular Institute Hospital | Minato-ku | Tokyo | Japan |
| Saiseikai Yokohama Tobu Hospital | Kanagawa | Yokohama | Japan |
| Shonan Kamakura General Hospital | Tokyo | Japan |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |