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| Name | Class |
|---|---|
| Medtronic Vascular | INDUSTRY |
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This is a prospective, multicenter, historical controlled study. The present clinical study will measure non-inferiority of 12 month TLF rate compared to historical control.The selected historical control is the Xience V arm from RESOLUTE All-Comer clinical study, that study is a prospective, multicenter, randomized, two-arm, international, open-label study.The historical control did not have angiographic follow up before 12 months, in the present clinical study, only subjects with clinical follow-up conducted at 12 months without any pre-specified angiographic assessment prior to 12 month clinical follow-up will be part of this analysis cohort. Out of the total 1200 patients, 900 patients (clinical follow-up cohort) will be included in this analysis cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Follow-up Cohort | The clinical FU cohort comprises among patients who underwent clinical FU at 9, 12, and 24 months after index PCI those who arbitrarily underwent angiographic FU at 22 months (±60 days) after index PCI and those who did not undergo angiographic follow-up at all during the entire study period. | ||
| Routine Angiographic Follow-up Cohort | The routine angiographic FU cohort comprises patients who underwent clinical FU at 9, 12, and 24 months after index PCI those who undergo angiographic FU at 10 months (±60 days) after index PCI. |
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| Measure | Description | Time Frame |
|---|---|---|
| TLF (target lesion failure) | The composite of Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel) or Target Lesion Revascularization (TLR; clinically indicated) (= device oriented endpoint). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Delivery success | Complete passage of the stent across the target lesion with full expansion of the stent to the desired diameter at the desired location. Note: Failed delivery: failure to pass the stent through the guiding catheter into the coronary artery,failure to pass it completely across the target lesion, or failure to expand the stent to its desired diameter. Failed delivery includes proximal deployment defined as those instances of failed delivery when the stent could be advanced only partially across the target lesion but was deployed nonetheless by full expansion. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of long-term clinical outcomes due to a difference in follow-up procedure (clinical follow-up or routine angiographic follow-up) after index PCI. | 24 months after index PCI | |
| Evaluation of medical economics | The objectives of this clinical study are to 1) assess the efficacy and safety of RI-ZES at 10 and 22 months (±60 days) after index PCI for routine angiographic FU after index PCI and to 2) investigate its medical costs. |
Inclusion Criteria:
Exclusion Criteria:
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Among 1,200 patients to be registered at the website database, the first 900 continuously registered patients will be then assigned to the clinical follow-up cohort, and the remaining 300 patients to the routine angiographic follow-up cohort.
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| Name | Affiliation | Role |
|---|---|---|
| Masato Nakamura, MD | Toho University Medical Center Ohashi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Non-profit organization Associations for Establishment of Evidence in Interventions | Minato-ku, Tokyo | 105-0013 | Japan |
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| stent implantation until hospital discharge (average 1-5 days) |
| Lesion success | Lesion success defined as the attainment of a less than 50% residual stenosis by any percutaneous method. | stent implantation until hospital discharge (average 1-5 days) |
| TLF (target lesion failure) | The composite of Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel) or Target Lesion Revascularization (TLR; clinically indicated) (= device oriented endpoint). | 30 days, 6, 9, 12, 24 and 36 months after index PCI |
| TVF (target vessel failure) | The composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods. | 30 days, 6, 9, 12, 24 and 36 months after index PCI |
| MACE (major adverse cardiac event) | All-cause death, myocardial infarction (QWMI and NQWMI), emergency coronary artery bypass graft(CABG), or TLR by medical or surgical procedure. | 30 days, 6, 9, 12, 24 and 36 months after index PCI |
| Stent thrombosis | Incidence of ARC-defined "definite" and "probable" stent thrombosis, and the combined incidence of "definite/probable" stent thrombosis. | 30 days, 6, 9, 12, 24 and 36 months after index PCI |
| Duration of dual antiplatelet therapy | Duration of DAPT after index PCI including the reason for interruption and discontinuation. | 12, 24 and 36 months after index PCI |
| Cerebrovascular accident |
| 30 days, 6, 9, 12, 24 and 36 months afetr index PCI |
| Procedure success | The attainment of < 50%, residual stenosis of the target lesion and no in-hospital MACE as reported by the physician. | stent implantation until hospital discharge (average 1-5 days) |
| 24 months after index PCI |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D001157 | Arterial Occlusive Diseases |
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