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The objective of this study is a comparative evaluation of BuMA Supreme™ stent and of Xience V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after implanting in relatively high bleeding risk patients with coronary artery disease using OCT.
This is a prospective, multicenter, randomized, non-inferiority study, which will enroll a total of 80 subjects from approximately 8 centers. All subjects will be firstly randomly assigned to 1st month OCT (40 pts) or 2nd month OCT group(40 pts). Then both two groups will be randomly assigned to undergoing implantation of BuMA Supreme™ stent (20 pts) or Xience V/Prime stent (20 pts). If non-inferiority was met, superiority test will be planned.
All of the patients be followed up to 2 years. The follow-up visits will be conducted at 1 or 2 months (including QCA/OCT investigation), 3 months, 6 months, 1 and 2 years post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1st month OCT group implanted BuMA Supreme™ stent | Experimental | This group contains 20 subjects. All subjects in this group will undergoing implantation of BuMA Supreme™ stent. The Primary Endpoint of this group is 1st month QCA and OCT assessment. |
|
| 1st month OCT group implanted Xience V/Prime stent | Active Comparator | This group contains 20 subjects. All subjects in this group will undergoing implantation of Xience V/Prime stent. The Primary Endpoint of this group is 1st month QCA and OCT assessment. |
|
| 2st month OCT group implanted BuMA Supreme™ stent | Experimental | This group contains 20 subjects. All subjects in this group will undergoing implantation of BuMA Supreme™ stent. The Primary Endpoint of this group is 2st month QCA and OCT assessment. |
|
| 2st month OCT group implanted Xience V/Prime stent | Active Comparator | This group contains 20 subjects. All subjects in this group will undergoing implantation of Xience V/Prime stent. The Primary Endpoint of this group is 2st month QCA and OCT assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BuMA Supreme™ stent | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of the struts' neointimal coverage (%) at 1 or 2 months follow-up by OCT assessment. | 1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group | 1 or 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neointimal hyperplasia area/volume | 1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group | 1 or 2 months |
| Mean/Minimal Stent diameter/area/volume |
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Inclusion Criteria:
18 to 85 years.
Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study).
Any one or more situation listed below can be considered the patient at high bleeding risk by the doctor:
Adjunctive oral anticoagulation treatment planned to continue after PCI;
Baseline Hb ≥11 g/dl (or anemia requiring TF during the prior 4 weeks);
Any prior intra-cerebral bleed at any time;
Any stroke during the past year;
Hospital admission for bleeding during the prior 12 months;
Non-skin cancer diagnosed or treated ≤ 3 years;
Planned daily NSAID (other than aspirin) or steroids for ≥ 30 days after PCI;
Planned major surgery (within 1 year);
Renal failure (calculated creatinine clearance ≥ 40 ml/min);
Thrombocytopenia (≥ 100,000/mm3);
Severe chronic liver disease (variceal hemorrhage, ascites, hepatic encephalopathy or jaundice);
Expected non-compliance to prolonged DAPT for other medical (nonfinancial)reasons ;
The patient has a planned intervention of up to two de novo lesions, in different epicardial vessels.
Lesion(s) must have a visually estimated diameter stenosis of ≥70% and <100%.
Reference Vessel Diameter (RVD) must be between 2.5- 4.0mm, and the vessel length must be no more than 40 mm.
Written informed consent.
The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT controls at 1 or 2 month.
Exclusion Criteria:
OCT exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Yundai Y Chen, Ph.D. | the PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31174600 | Derived | Li B, Jin QH, Chen YD, Wang CQ, Shi B, Su X, Fu GS, Wu YQ, Zhou XC, Yuan ZY. A prospective, multicenter, randomized OCT study of early neointimal condition at first and second months after BuMA Supreme stent versus XIENCE stent implantation in high-bleeding-risk coronary artery disease patients: study protocol for a randomized controlled trial. Trials. 2019 Jun 7;20(1):335. doi: 10.1186/s13063-019-3361-0. |
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| Xience V/Prime stent |
| Device |
|
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
| 1 or 2 months |
| Mean/Minimal Lumen diameter/area/volume | 1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group | 1 or 2 months |
| Mean/maximal thickness of the struts coverage | 1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group | 1 or 2 months |
| Incomplete strut apposition | 1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group | 1 or 2 months |
| Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months | 1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group | 1 or 2 months |
| Late Lumen Loss | 1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group | 1 or 2 month |
| Binary Restenosis (DS ≥50%) | All measurements will be made of the in-stent, in-segment, proximal and distal stent margins. | 1 or 2 months |
| Acute success rate | It includes the device success,lesion success and procedural success. | up to 7 days |
| Device-oriented Composite Endpoints and its individual components | Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, Myocardial Infarction(MI) not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization. | 1 or 2, 3, 6 months, 1 year, 2 years |
| Stent thrombosis according to the ARC definitions | Definite and probable stent thrombosis during acute, subacute, later and very late phase. | 1 or 2, 3, 6 months, 1 year, 2 years |
| bleeding events | 1 or 2, 3, 6 months, 1 year, 2 years |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D058426 | Neointima |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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