MULTivessel Immediate Versus STAged RevaScularization in Acute Myocardial Infarction -The MULTISTARS AMI Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of the trial is to compare, in patients presenting with ST segment elevation myocardial infarction (STEMI) and multi-vessel disease (MVD), the safety and efficacy of immediate complete revascularization of all significant coronary lesions versus culprit vessel only revascularization and staged percutaneous coronary intervention (PCI) of all significant coronary lesions (within 19 to 45 days), in a non-inferiority trial using a third generation, biodegradable-polymer, everolimus-eluting stent.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Direct Complete Versus Staged Complete Revascularization in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease

NCT03621501

Acute Coronary Syndrome

ACTIVE_NOT_RECRUITING NA

Multivessel Stenting Versus Staged Revascularization With Zotarolimus-eluting Stent for STEMI

NCT01781715

ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease

UNKNOWN PHASE4

Efficacy and Safety Study of Deferred Stenting in Patients With STEMI

NCT02324348

ST-segment Elevation Myocardial Infarction

COMPLETED NA

Drug-eluting Balloon in Acute Myocardial Infarction

NCT00856765

Coronary Artery Disease Atherosclerosis Thrombosis +1 more

COMPLETED PHASE2/PHASE3

FFR Versus Angiography-Guided Strategy for Management of AMI With Multivessel Disease

NCT02715518

Acute Myocardial Infarction

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD in stable hemodynamic conditions, undergoing after successful PCI of the culprit lesion either (1:1 randomization) immediate revascularization of all additional target lesions during the index procedure or staged PCI of all additional target lesions (within 19 to 45 days) using the Boston Scientific Synergy™ stent.

The goal of this trial is to compare two treatment strategies that are currently performed in clinical practice: immediate complete revascularization versus staged complete revascularization in patients with STEMI and MVD.

Patients randomized to immediate complete revascularization will have treated during the index procedure, after revascularization of the culprit lesion, all significant non-culprit coronary lesions.

Patients randomized to staged complete revascularization will have treated during the index procedure only the culprit lesion, and they will be hospitalized after 19-45 days for complete revascularization of all significant non-culprit coronary lesions.

For both groups, lesion are considered significant when causing a ≥70% diameter stenosis by visual estimation in at least two projections on the coronary angiogram.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ST-elevation Myocardial Infarction Multivessel Coronary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Staged complete PCI

Patients randomized to staged complete PCI will have treated during the index admission only the culprit lesion and they will be hospitalized after 19-45 days, to complete the coronary revascularization on all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

Group Type ACTIVE_COMPARATOR

Staged complete PCI

Intervention Type PROCEDURE

During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 19-45 days to undergo PCI of all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

Synergy™ stent

Intervention Type DEVICE

Bioabsorbable Polymer Drug-Eluting Stent

Immediate complete PCI

Patients randomized to immediate complete PCI will have treated immediately after the revascularization of the culprit lesion during the index procedure all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

Group Type EXPERIMENTAL

Immediate complete PCI

Intervention Type PROCEDURE

During the index procedure, patients will have treated with primary PCI the culprit lesion, as well as all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

Synergy™ stent

Intervention Type DEVICE

Bioabsorbable Polymer Drug-Eluting Stent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Staged complete PCI

During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 19-45 days to undergo PCI of all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

Intervention Type PROCEDURE

Immediate complete PCI

During the index procedure, patients will have treated with primary PCI the culprit lesion, as well as all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.

Intervention Type PROCEDURE

Synergy™ stent

Bioabsorbable Polymer Drug-Eluting Stent

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 years
* Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset)
* Suitability for PCI from femoral or radial access
* Coronary anatomy suitable for complete coronary revascularization with Synergy® stent implantation
* Identifiable culprit lesion/artery
* At least one non-culprit coronary stenosis ≥ 70% in at least two projections, in a vessel with a lumen diameter ≥2.25 - ≤5.75 mm, other than the culprit artery
* TIMI Flow 3 or TIMI flow 2 after revascularization of the culprit artery
* Stable hemodynamics at the end of the culprit vessel revascularization

Exclusion Criteria

* Inability to give informed consent
* Cardiogenic shock
* Prolonged resuscitation \>10 min
* General unsuitability for PCI
* Need for emergency CABG
* Previous CABG
* Planned hybrid revascularization
* Coronary artery dissection
* STEMI due to ST
* Previous documented allergic reaction to everolimus or to any stent material
* Severe mechanical complication of acute myocardial infarction
* Pre-existing severe renal failure (eGFR \<30 mL/min) or renal replacement therapy
* Chronic total occlusion of a major coronary artery
* Left main stem stenosis ≥50% or left main stem equivalent (ostial left anterior descending and ostial circumflex stenosis ≥70%)
* In-stent restenosis
* Panned coronary, cerebrovascular, or peripheral arterial revascularization
* Planned cardiac or major surgery
* Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 Inhibitor for at least 90 days, except for patients on oral anticoagulation
* Known pregnancy at the time of inclusion
* Participation in another clinical study with an investigational product
* Life expectancy \<1 year

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No