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| Name | Class |
|---|---|
| Biosensors Japan Co. Ltd. | UNKNOWN |
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Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients in Japan. All patients will receive a DCS and will be followed for 2 years.
In this study all patients will receive the a Drug Coated Stent and will receive one month Dual Anti Platelet Therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Coated Stent | Other | All patients in the one arm will be treated by PCI with the Drug Coated Stent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention (PCI) | Procedure |
| ||
| Dual Anti Platelet Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients that experienced either a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis. | 1 year | |
| The number of patients that experienced a clinically driven target lesion revascularization | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients that experienced a cardiac death, myocardial infarction and/or a definite/probable stent thrombosis | 2 years | |
| The number of patients that experienced a clinically driven target lesion revascularization | 2 years |
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Inclusion Criteria:
Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or MORE of the following:
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 |
|---|---|---|---|---|---|---|
| Shonan Kamakura General Hospital | Kamakura | Kanagawa | 247-8533 | Japan |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| D000080903 | Dual Anti-Platelet Therapy |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Drug |
All patients will receive Dual Anti Platelet Therapy for one month |
|
| The number of patients that experienced a Bleeding per BARC criteria | 30, 60 and 120 days, and 12 and 24 months |
| The number of patients that experienced a cardiac death | 30, 60 and 120 days, and 12 and 24 months |
| The number of patients that experienced a definite/probable stent thrombosis. | 30, 60 and 120 days, and 12 and 24 months |
| The number of patients that experienced a myocardial infarction | 30, 60 and 120 days, and 12 and 24 months |
| D019060 | Minimally Invasive Surgical Procedures |
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |