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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
| Kurume University | OTHER |
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This is a prospective, non-randomized, single center clinical trial to assess neointimal coverage on the stent or scaffold strut and apposition of SYNERGYâ„¢ and ABSORB in minimum of 12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using OCT and CAS
All of the subject will received SYNERGYâ„¢ stent in one of the blocked coronary artery and ABSORB scaffold strut in the other artery. All subjects must have 2 coronary arteries stenosis of more than 70%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary artery implanted with SYNERGY stent | Active Comparator | One of the blocked coronary artery of a patient will received SYNERGY stent |
|
| Coronary artery implanted with ABSORB scaffold | Active Comparator | Another blocked coronary artery of the same patient will received ABSORB scaffold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYNERGY stent | Device |
| ||
| BVS ABSORB scaffold |
| Measure | Description | Time Frame |
|---|---|---|
| Apposition and neointimal coverage on the stent and scaffold strut | Neointimal coverage on the stent and scaffold strut and their apposition using OCT and CAS at 4 month after the stent implantation. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Apposition and neointimal coverage on the stent and scaffold strut | Neointimal coverage on the stent or scaffold and their apposition using OCT and CAS at 12 month after stent implantation | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wan Azman Wan Ahmad | University Malaya Medical Center | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 4, 2021 | |
| Reset | Oct 28, 2021 | |
| Release | Jun 4, 2025 | |
| Reset | Jun 23, 2025 | |
| Release | Jun 23, 2025 | |
| Reset | Jul 10, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 4, 2021 | Oct 28, 2021 | |||
| Jun 4, 2025 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Device |
|
| Jun 23, 2025 |
| Jun 23, 2025 | Jul 10, 2025 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |