| Primary | Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | TLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR) | | Posted | | Number | 95% Confidence Interval | percentage of subjects with TLF | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). | | OG001 | Durable Polymer EES (XIENCE or Promus DES) (ITT) | The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems. |
| | | Title | Denominators | Categories |
|---|
| TLF | | | Title | Measurements |
|---|
| - OG0005.4(4.1 to 6.9)
- OG0015.1(3.4 to 7.3)
|
| | Cardiac Death | | |
| |
| Secondary | Number of Participants With Cardiac Death | Any death due to proximate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. | Number of participants with Cardiac Death | Posted | | Count of Participants | | Participants | | Assessed at 30 days, 6 months, 12 months, and up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). | | OG001 | Durable Polymer EES (XIENCE or Promus DES) (ITT) | The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems. |
|
| Secondary | Number of Participants With Major Adverse Cardiac Events (MACE) | All-cause death, myocardial infarction, or target vessel revascularization (reported as a composite) | | Posted | | Count of Participants | | Participants | | Assessed at 30 days, 6 months, 12 months, and up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). | | OG001 | Durable Polymer EES (XIENCE or Promus DES) (ITT) | The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems. |
| |
| Secondary | Number of Participants With Myocardial Infarction (MI) | Defined according to the modified Third Universal Definition as evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. | | Posted | | Count of Participants | | Participants | | Assessed at 30 days, 6 months, 12 months, and up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). | | OG001 | Durable Polymer EES (XIENCE or Promus DES) (ITT) | The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems. |
| |
| Secondary | Number of Participants With Stent Thrombosis | Definite or probable (ARC-defined), classified as early, late, or very late | | Posted | | Count of Participants | | Participants | | Assessed at 30 days, 6 months, 12 months, and up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). | | OG001 | Durable Polymer EES (XIENCE or Promus DES) (ITT) | The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems. |
| |
| Secondary | Number of Participants With Bleeding Complications (BARC Definitions) | Evaluated as components and as a composite of BARC Type 3 or 5 bleeding, including: Type 3a: Over bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to bleed); Any transfusion with over bleeding Type 3b: Overt bleeding plus hemoglobin drop ≥5 g/dL* (provided hemoglobin drop is related to bleed); Cardiac tamponade; Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid); Bleeding requiring intravenous vasoactive agents Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); Subcategories confirmed by autopsy or imaging or lumbar puncture; Intraocular bleed comprising vision Type 5: Fatal bleeding | | Posted | | Count of Participants | | Participants | | Assessed at 30 days, 6 months, 12 months, and up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). | | OG001 | Durable Polymer EES (XIENCE or Promus DES) (ITT) |
|
| Secondary | Lesion Success | Defined as attainment of <30% residual stenosis, as measured by quantitative coronary angiography (QCA) using any percutaneous method [evaluated post-procedure] | | Posted | | Count of Units | | Number of Lesions Treated | | Post-Procedure | Number of Lesions Treated | Number of Lesions Treated | | ID | Title | Description |
|---|
| OG000 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). | | OG001 | Durable Polymer EES (XIENCE or Promus DES) (ITT) | The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems. |
| |
| Secondary | Device Success | Defined as attainment of <30% residual stenosis of the target lesion measured by QCA using the assigned device [evaluated post-procedure] | | Posted | | Count of Units | | Total Number of Devices | | Post-Procedure | Total Number of Devices | Total Number of Devices | | ID | Title | Description |
|---|
| OG000 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). | | OG001 | Durable Polymer EES (XIENCE or Promus DES) (ITT) | The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems. |
| |
| Secondary | Procedure Success | Defined as lesion success without the occurrence of in-hospital MACE [evaluated in-hospital] | | Posted | | Count of Participants | | Participants | | Post procedure/Prior to Discharge, an average of 3 days | | | | ID | Title | Description |
|---|
| OG000 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). | | OG001 | Durable Polymer EES (XIENCE or Promus DES) (ITT) | The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems. |
| |
| Secondary | Clinically-driven Target Vessel Revascularization (TVR) | Any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. A revascularization is considered clinically driven if angiography at follow-up shows a percent diameter stenosis ≥ 70% (by core lab quantitative coronary angiography assessment) OR percent diameter stenosis ≥ 50% (by core lab quantitative coronary angiography assessment) accompanied by one of the following:103
- a positive history of recurrent angina pectoris, presumably related to the target vessel;
- objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent) presumably related to the target vessel;
- abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve).
| | Posted | | Count of Participants | | Participants | | Assessed at 30 days, 6 months, 12 months, and up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). |
|
| Secondary | Target Vessel Failure (TVF) | The composite of cardiac death, target vessel-related myocardial infarction, and clinically-driven target vessel revascularization. | | Posted | | Count of Participants | | Participants | | Assessed at 30 days, 6 months, 12 months, and up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | BuMA Supreme Coronary Stent System (ITT) | The BuMA Supreme Biodegradable Drug Coated Coronary Stent System is a device / drug combination product consisting of a drug-coated balloon expandable stent and a rapid exchange delivery system. The cobalt chromium (CoCr) stent is coated with a very thin, non-erodable layer of poly n-butyl methacrylate (PBMA) that is covalently bonded to the metal surface through a proprietary electro-grafting (eG™) process. A topcoat is then applied that contains sirolimus, the active ingredient, embedded in a biodegradable polymer, poly lactic co-glycolic acid (PLGA). | | OG001 | Durable Polymer EES (XIENCE or Promus DES) (ITT) | The control comparator is durable polymer everolimus-eluting stent systems (DP EES), consisting of the Xience™ family of durable polymer cobalt chromium everolimus-eluting coronary stent systems (Abbott Vascular, Santa Clara, CA, US), and the PROMUS Element™ family of everolimus-eluting coronary stent systems. |
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