Acute Coronary SyndromeCOVER-AMINCT02890589
Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction
A study testing SYNERGY stent and ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold) in people with Acute Coronary Syndrome, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- SYNERGY stent and ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction: An Intracoronary Optical Coherence Tomography Randomized Study
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.
Read the detailed description
Single center, simple-blind randomized controlled trial, comparing the SYNERGY stent with the BVS device through a parallel group design.
- Conditions
- Acute Coronary Syndrome
- Being tested
- SYNERGY stent, ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)
- Keywords
- Acute coronary syndrome, ST (Software Test) -elevation
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNERGY stentDevice
Also called SYNERGY (Platinum chromium coronary 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)Device
Also called ABSORB
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.
| Study group | Role | What they receive |
|---|---|---|
| SYNERGY Stent | Experimental | 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. Receives: Device: SYNERGY stent |
| 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. Receives: Device: ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of uncovered stent struts at 3-months
To assess strut coverage
Measured: at 3-months
Secondary outcomes (7)
Percentage of malposed uncovered struts
Assessed by optical coherence tomography
Measured: at 3 months
Frequency of abnormal intrastent tissue
Assessed by optical coherence tomography
Measured: at 3 months
Percentage of net volume obstruction
Assessed by optical coherence tomography
Measured: at 3 months
Rates of in-stent late loss
Measured: at 3 months
Rates of in-segment late loss
Measured: at 3 months
Rates of binary restenosis
Measured: at 3 months
Plasma CXCL10 protein as a potential of re-endothelialization
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Didier CARRIE, MD Phd, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890589
- Sponsor's protocol ID
- RC31/15/7743
- Acronym
- COVER-AMI
- Status last verified
- May 2026
- First submitted
- 28 Jun 2016
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30975219
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction: An Intracoronary Optical Coherence Tomography Randomized Study
- ClinicalTrials.gov ID
- NCT02890589
- Acronym / sponsor ID
- COVER-AMI / RC31/15/7743
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, ST (Software Test) -elevation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Jul 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYNERGY Stent | Experimental | Device: SYNERGY stentThe 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. |
| BVS device | Experimental | 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYNERGY stentAlso: SYNERGY (Platinum chromium coronary 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. | Device | SYNERGY Stent |
| ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)Also: ABSORBCoronary 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. | Device | BVS device |
Primary outcome
Number of uncovered stent struts at 3-months
Time frame: at 3-months
To assess strut coverage
7 secondary outcomes
Percentage of malposed uncovered struts
Time frame: at 3 months
Frequency of abnormal intrastent tissue
Time frame: at 3 months
Percentage of net volume obstruction
Time frame: at 3 months
Rates of in-stent late loss
Time frame: at 3 months
Rates of in-segment late loss
Time frame: at 3 months
Rates of binary restenosis
Time frame: at 3 months
Plasma CXCL10 protein as a potential of re-endothelialization
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Results publication: PubMed 30975219Lhermusier 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.
- Individual participant dataSharing planned: No
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier CARRIE, MD Phd principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SYNERGY stent and ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold) in people with Acute Coronary Syndrome, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of uncovered stent struts at 3-months (time frame: at 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.