Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Device: ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold); Device: SYNERGY stent

• Registration Number: NCT02890589
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2016-06-28
• Study Start: 2016-07
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-07
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BVS device	ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)	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.
SYNERGY Stent	SYNERGY stent	The SYNERGY™ stent is a Device marked CE (European Conformity), platinum chromium coronary stent, currently developped by Boston Scientific™. This stent has been designed with the goal of providing optimal and rapid healing within the vessel using a bioabsorbable polymer to elute everolimus.

Primary Outcome Measures

Name	Time	Method
Number of uncovered stent struts at 3-months	at 3-months	To assess strut coverage

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Didier CARRIE; 🇫🇷 Toulouse, France