Acute Coronary Syndrome
Conditions
Keywords
Acute coronary syndrome, ST (Software Test) -elevation
Brief summary
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.
Detailed description
Single center, simple-blind randomized controlled trial, comparing the SYNERGY stent with the BVS device through a parallel group design.
Interventions
DEVICESYNERGY stent
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.
DEVICEABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)
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.
Sponsors
University Hospital, Toulouse
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Acute coronary syndrome with ST-elevation, * One culprit lesion eligible for percutaneous coronary intervention (PCI) with stent implantation, * Reference vessel measuring 2.5 mm to 3.75 mm per visual estimation, without extreme vessel tortuosity, * thrombolysis in myocardial infarction (TIMI) 3 flow before stent deployment in the target vessel, * Patient with at least 1 lesion eligible for planned PCI next to the culprit lesion, * Patient affiliated to the French national health care system, * Patient agreed to participate after full information on the study (signature of an informed consent).
Exclusion criteria
* Acute coronary syndrome with ST-elevation, * One culprit lesion eligible for percutaneous coronary intervention (PCI) with stent implantation, * Reference vessel measuring 2.5 mm to 3.75 mm per visual estimation, without extreme vessel tortuosity, * TIMI 3 flow before stent deployment in the target vessel, * Patient with at least 1 lesion eligible for planned PCI next to the culprit lesion, * Patient affiliated to the French national health care system, * Patient agreed to participate after full information on the study (signature of an informed consent).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of uncovered stent struts at 3-months | at 3-months | To assess strut coverage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of malposed uncovered struts | at 3 months | Assessed by optical coherence tomography |
| Frequency of abnormal intrastent tissue | at 3 months | Assessed by optical coherence tomography |
| Percentage of net volume obstruction | at 3 months | Assessed by optical coherence tomography |
| 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 | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORDidier CARRIE, MD Phd
University Hospital, Toulouse
Outcome results
None listed