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

Acute Coronary Syndrome Clinical Trial

— COVER-AMI  

Official title:

Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction: An Intracoronary Optical Coherence Tomography Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890589
• Other study ID #: RC31/15/7743
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: February 2018

Study information

• Verified date: August 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Single center, simple-blind randomized controlled trial, comparing the SYNERGY stent with the BVS device through a parallel group design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction

Intervention

Device:
• SYNERGY 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.
• ABSORB (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.

Locations

Country	Name	City	State
France	Didier CARRIE	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Boston Scientific Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of uncovered stent struts at 3-months	To assess strut coverage	at 3-months
Secondary	Percentage of malposed uncovered struts	Assessed by optical coherence tomography	at 3 months
Secondary	Frequency of abnormal intrastent tissue	Assessed by optical coherence tomography	at 3 months
Secondary	Percentage of net volume obstruction	Assessed by optical coherence tomography	at 3 months
Secondary	Rates of in-stent late loss		at 3 months
Secondary	Rates of in-segment late loss		at 3 months
Secondary	Rates of binary restenosis		at 3 months
Secondary	Plasma CXCL10 protein as a potential of re-endothelialization		at 3 months