Clinical trial NCT02890589: Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction
Official title: Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction: An Intracoronary Optical Coherence Tomography Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Acute coronary syndrome
ST (Software Test) -elevation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2016-09-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of uncovered stent struts at 3-months
timeFrame: at 3-months
Secondary outcomes:
measure: Percentage of malposed uncovered struts
timeFrame: at 3 months
measure: Frequency of abnormal intrastent tissue
timeFrame: at 3 months
measure: Percentage of net volume obstruction
timeFrame: at 3 months
measure: Rates of in-stent late loss
timeFrame: at 3 months
measure: Rates of in-segment late loss
timeFrame: at 3 months
measure: Rates of binary restenosis
timeFrame: at 3 months
measure: Plasma CXCL10 protein as a potential of re-endothelialization
timeFrame: at 3 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Didier CARRIE
Study officials:
affiliation: University Hospital, Toulouse
name: Didier CARRIE, MD Phd
role: PRINCIPAL_INVESTIGATOR
References: