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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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To assess strut coverage in patients presenting an acute myocardial infarction and treated either with the SYNERGY stent or the Bioresorbable Vascular Scaffold, through a parallel group design.
Single center, simple-blind randomized controlled trial, comparing the SYNERGY stent with the BVS device through a parallel group design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYNERGY Stent | Experimental | The SYNERGYâ„¢ stent is a Device marked CE (European Conformity), platinum chromium coronary stent, currently developped by Boston Scientificâ„¢. This stent has been designed with the goal of providing optimal and rapid healing within the vessel using a bioabsorbable polymer to elute everolimus. |
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| BVS device | Experimental | The ABSORB Everolimus-eluting Bioresorbable Vascular Scaffold (BVS 1.1, Abbott Vascular, California, USA, CE approved) is Device marked CE, currently the most studied PLA (Polylactic acid) based scaffold. It consists of PLLA (Poly I-lactic acid) backbone with 1:1 PDLLA (Poly-DL Lactic Acid) drug surface coating and a total strut thickness of 156 μm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYNERGY stent | Device | Coronary angiography will assess the presence of at least one eligible coronary lesion requiring stent implantation before revascularization by angioplasty. Stent will be implanted according to manufacturer's and competent authority recommendations. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of uncovered stent struts at 3-months | To assess strut coverage | at 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of malposed uncovered struts | Assessed by optical coherence tomography | at 3 months |
| Frequency of abnormal intrastent tissue | Assessed by optical coherence tomography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier CARRIE, MD Phd | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Didier CARRIE | Toulouse | Toulouse | 31500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30975219 | Result | Lhermusier T, Ohayon P, Boudou N, Bouisset F, Campelo-Parada F, Roncalli J, Elbaz M, Carrie D. Re-endothelialisation after Synergy stent and Absorb bioresorbable vascular scaffold implantation in acute myocardial infarction: COVER-AMI study. Trials. 2019 Apr 11;20(1):210. doi: 10.1186/s13063-019-3293-8. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold) | Device | Coronary angiography will assess the presence of at least one eligible coronary lesion requiring stent implantation before revascularization by angioplasty. Stent will be implanted according to manufacturer's and competent authority recommendations. |
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| at 3 months |
| Percentage of net volume obstruction | Assessed by optical coherence tomography | at 3 months |
| Rates of in-stent late loss | at 3 months |
| Rates of in-segment late loss | at 3 months |
| Rates of binary restenosis | at 3 months |
| Plasma CXCL10 protein as a potential of re-endothelialization | at 3 months |