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The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in terms of the extent of neointima formation at 3 months after implantation using OCT.
This is a prospective, single center, randomized, open-label, non-inferiority study, which will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority was met, superiority test will be planned.
About 70 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Fuwai Hospital,will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio).
All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months (including angiographic/OCT investigation), 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 |
|---|---|---|---|
| BuMA stent | Other | This study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio). BuMA stent Arm:About 35 patients will undergoing implantation of BuMA stent.All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months(including angiographic/OCT investigation), 6 months, 1 and 2 years post PCI,in order to observe the Primary Endpoint and Secondary Endpoints. |
|
| EXCEL stent | Other | This study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio). EXCEL stent Arm:About 35 patients will undergoing implantation of EXCEL stent.All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months(including angiographic/OCT investigation), 6 months, 1 and 2 years post PCI,in order to observe the Primary Endpoint and Secondary Endpoints. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BuMA stent | Device | About 35 patients will undergoing implantation of BuMA stent and receive 6 months dual antiplatelet therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment. | The primary outcome measure is the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment. | three months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Neointimal hyperplasia area/volume | It will be measure the neointimal hyperplasia area/volume at 3 months follow-up by OCT assessment. | three months after surgery |
| Mean/Minimal Stent diameter/area/volume |
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Inclusion Criteria:
Exclusion Criteria:
OCT exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Yang Y Jin, president | Fuwai Hospital, Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Science | Beijing | Beijing Municipality | 100037 | China |
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| EXCEL stent | Device | About 35 patients will undergoing implantation of EXCEL stent and receive 6 months dual antiplatelet therapy. |
|
It will be measure the Mean/Minimal stent diameter/area/volume at 3 months follow-up by OCT assessment.
| three months after surgery |
| Mean/Minimal Lumen diameter/area/volume | It will be measure the Mean/Minimal Lumen diameter/area/volume at 3 months follow-up by OCT assessment. | three months after surgery |
| Mean/maximal thickness of the struts coverage | It will be measure the Mean/maximal thickness of the struts coverage at 3 months follow-up by OCT assessment. | three months after surgery |
| Incomplete strut apposition | It will be measure the incomplete strut apposition at 3 months follow-up by OCT assessment. | three months after surgery |
| Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months | three months after surgery |
| Late Lumen Loss at 3 months | three months after surgery |
| Binary Restenosis (DS ≥50%) at 3 months | All measurements will be made of the in-stent, in-segment, proximal and distal stent margins. | three months after surgery |
| Acute success rate | It includes the device success,lesion success and procedural success. | up to 7 days after surgery |
| Device-oriented Composite Endpoints and its individual components at 3 months | 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. | three months after surgery |
| Device-oriented Composite Endpoints and its individual components at 6 months | Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization. | six months after surgery |
| Device-oriented Composite Endpoints and its individual components at 1 year | Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization. | one year after surgery |
| Device-oriented Composite Endpoints and its individual components at 2 years | Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization. | 2 years after surgery |
| Stent thrombosis according to the ARC definitions at 3 months | three months after surgery |
| Stent thrombosis according to the ARC definitions at 6 months | six months after surgery |
| Stent thrombosis according to the ARC definitions at 1 year | one year after surgery |
| Stent thrombosis according to the ARC definitions at 2 years | 2 years after surgery |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D058426 | Neointima |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular 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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