Coronary Artery Disease
Conditions
Keywords
Drug-eluting stent
Brief summary
The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the XIENCE or Promus durable polymer coronary stents. This prospective, global, multi-center, randomized 2:1, single blind study will enroll up to 1632 subjects at up to 130 investigational sites in North America, Japan, and Europe. Subjects will have clinical follow-up in-hospital and at 30 days, 6 months, 12 months, and 2, 3, 4, and 5 years.
Interventions
DEVICEBuMA Supreme DES
Implant BuMA Supreme stent only
DEVICEXience or Promus DES
Implant XIENCE family or Promus family only
Sponsors
Sino Medical Sciences Technology Inc.
Nova Vascular LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient is a male or non-pregnant female ≥20 years of age. 2. The patient has symptomatic ischemic heart disease, including chronic stable angina (and/or objective evidence of myocardial ischemia on functional study or invasive fractional flow reserve \[FFR\] measurement) or acute coronary syndromes (UA or NSTEMI), that requires elective or urgent percutaneous coronary intervention (PCI). 3. The patient is an acceptable candidate for percutaneous coronary intervention (PCI) with drug-eluting stents, and for emergent coronary bypass graft (CABG) surgery. 4. The patient is willing to comply with specified follow-up evaluations. 5. The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).
Exclusion criteria
1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test. 2. Patients with a history of bleeding diathesis or coagulopathy, contraindications to anti-platelet and/or anticoagulant therapy, or who will refuse transfusion. 3. Patients who are receiving or will require chronic anticoagulation therapy for any reason. 4. Known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, ADP receptor antagonists (clopidogrel, prasugrel, ticagrelor, ticlopidine), cobalt chromium, 316L stainless steel or platinum, sirolimus or its analogues, and/or contrast sensitivity that cannot be adequately pre-medicated. 5. ST-segment elevation myocardial infarction (STEMI) at index presentation or within 7 days prior to randomization. 6. Known LVEF \<30% or cardiogenic shock requiring pressors or mechanical circulatory assistance (e.g., intra-aortic balloon pump, left ventricular assist device, other temporary cardiac support blood pump). 7. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation or Cockcroft-Gault formula) or dialysis at the time of screening. 8. Target vessel percutaneous coronary intervention with stent placement in the previous 3 months. 9. Planned elective surgery that would require discontinuation of DAPT within 6 months of the index procedure. 10. Past or pending heart or any other organ transplant, or on the waiting list for any organ transplant. 11. Patients who are receiving immunosuppressant therapy, or who have known immunosuppressive or severe autoimmune disease that will require chronic immunosuppressive therapy. NOTE: Corticosteroid use is permitted. 12. Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound data interpretation, or is associated with a life expectancy of less than 1 year. 13. Current participation in another investigational drug or device study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Target Lesion Failure (TLF) and Constituent Elements | 12 months | TLF is defined as the composite of cardiac death, target vessel related myocardial infarction (TV-MI), and clinically-driven target lesion revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cardiac Death | Assessed at 30 days, 6 months, 12 months, and up to 5 years | 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 Major Adverse Cardiac Events (MACE) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | All-cause death, myocardial infarction, or target vessel revascularization (reported as a composite) |
| Number of Participants With Myocardial Infarction (MI) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Defined according to the modified Third Universal Definition as evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. |
| Number of Participants With Stent Thrombosis | Assessed at 30 days, 6 months, 12 months, and up to 5 years | Definite or probable (ARC-defined), classified as early, late, or very late |
| Number of Participants With Bleeding Complications (BARC Definitions) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | 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 |
| Lesion Success | Post-Procedure | Defined as attainment of \<30% residual stenosis, as measured by quantitative coronary angiography (QCA) using any percutaneous method \[evaluated post-procedure\] |
| Device Success | Post-Procedure | Defined as attainment of \<30% residual stenosis of the target lesion measured by QCA using the assigned device \[evaluated post-procedure\] |
| Procedure Success | Post procedure/Prior to Discharge, an average of 3 days | Defined as lesion success without the occurrence of in-hospital MACE \[evaluated in-hospital\] |
| Clinically-driven Target Vessel Revascularization (TVR) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | 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 1. a positive history of recurrent angina pectoris, presumably related to the target vessel; 2. objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent) presumably related to the target vessel; 3. abnormal results of any invasive functional diagnostic test (e.g., Doppler flow velocity reserve, fractional flow reserve). |
| Target Vessel Failure (TVF) | Assessed at 30 days, 6 months, 12 months, and up to 5 years | The composite of cardiac death, target vessel-related myocardial infarction, and clinically-driven target vessel revascularization. |
Countries
Belgium, Canada, Japan, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
STUDY_CHAIRMartin B Leon, MD
Center for Interventional Vascular Therapy - Columbia University Medical Center / New York-Presbyterian Hospital, United States
PRINCIPAL_INVESTIGATORDean Kereiakes, MD
The Christ Hospital Physicians - Ohio Heart & Vascular, United States
PRINCIPAL_INVESTIGATORStephan Windecker, MD
Bern University Hospital Department for Cardiology, Switzerland
PRINCIPAL_INVESTIGATORShigeru Saito, MD
Shonan Kamakura General Hospital, Japan
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age <65 | 519 Participants |
| Age, Customized Age ≥65 | 839 Participants |
| Body Mass Index (kg/m^2) | 29.06 kg/m^2 STANDARD_DEVIATION 5.71 |
| Diastolic Blood Pressure (mmHg) | 74.9 mmHg STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 455 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 88 Participants |
| Height | 171.33 cm STANDARD_DEVIATION 9.76 |
| Pulse (bpm) | 69.0 bpm STANDARD_DEVIATION 12.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 192 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants |
| Race (NIH/OMB) White | 1295 Participants |
| Region of Enrollment Belgium | 76 Participants |
| Region of Enrollment Canada | 36 Participants |
| Region of Enrollment France | 55 Participants |
| Region of Enrollment Japan | 163 Participants |
| Region of Enrollment Netherlands | 124 Participants |
| Region of Enrollment Spain | 205 Participants |
| Region of Enrollment Switzerland | 19 Participants |
| Region of Enrollment United Kingdom | 70 Participants |
| Region of Enrollment United States | 710 Participants |
| Sex: Female, Male Female | 148 Participants |
| Sex: Female, Male Male | 1222 Participants |
| Systolic Blood Pressure (mmHg) | 134.0 mmHg STANDARD_DEVIATION 22.1 |
| Weight (kg) | 85.70 Kg STANDARD_DEVIATION 19.17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 79 / 1,086 | 41 / 543 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 210 / 1,086 | 113 / 543 |
Outcome results
None listed