MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction

Study Overview
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Brief Summary
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This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be followed for 5 years. All eligible patients (STEMI < 12 hours from onset of chest pain) will be randomized to Biotronik MAGMARISTM Sirolimus Eluting Bioresorbable Vascular Scaffold System (M-BRS) or Biotronik ORSIRO Sirolimus Eluting Coronary Stent System Endothelium-independent vasomotor response (NTG injection) will be analyzed at 12 months angiographic follow-up (Primary endpoint). In a subgroup of 40 patients Optical Coherence Tomography will be performed after the procedure and at 12 months follow-up. Angiographic (QCA pre- and post-procedure and at 12 months follow-up), OCT data (at 12 months follow-up) will be analyzed off-line by an independent core lab.

Official Title
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MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction

Conditions
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Acute Coronary Syndrome, ST Segment Elevation Myocardial Infarction, Stent

Intervention / Treatment
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* Device: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical: At least 18 years of age. ST-segment elevation Myocardial Infarction documented in an ambulance or in a Cathlab, with ≥2 mm ST segment elevation in at least two contiguous leads, presenting in the Cathlab <12 hours after the onset of symptoms lasting ≥20 min requiring primary PCI. Target lesion must be a de-novo lesion located in a native vessel. The patient accepts Informed Consent The patient understands and accepts clinical follow-up and angiographic control. Angiographic: Vessel size should match available M-BRS scaffold sizes (≥2.75 mm, and ≤3.7 mm by visual assessment). Lesion preparation by either manual thrombectomy or pre-dilatation has been successful, with opening of the vessel and TIMI ≥2 and residual stenosis <20%. Exclusion Criteria: Pregnancy. Known intolerance to aspirin, heparin, stainless steel, sirolimus, and contrast material. Distal vessel occlusion after recanalization STEMI due to stent/scaffold thrombosis Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal m-BRS placement. Fibrinolysis prior to PCI Known thrombocytopenia (PLT< 100,000/mm3) Active bleeding or coagulopathy or patients at chronic anticoagulation therapy Cardiogenic Shock Significant comorbidities precluding clinical/angiographic FU (as judged by investigators) Major planned surgery that requires discontinuation of dual antiplatelet therapy. Diffuse coronary artery disease that will require CABG Chronic kidney disease with GFR<30 ml/min

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomised to one of two groups: MAGMARIS stent arm or ORSIRO stent arm in the ratio of 1:1
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magmaris<br>Percutaneous coronary intervention by means of Magnesium-based sirolimus-eluting bioresorbable scaffold implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy. | Device: Percutaneous coronary intervention<br>* PCI + stent implantation<br>* Other names: stent implantation;|
| Placebo Comparator: Orsiro<br>Percutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy. | Device: Percutaneous coronary intervention<br>* PCI + stent implantation<br>* Other names: stent implantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent/scaffold vasodilatory endothelium independent response | in-stent/scaffold vasodilatory response ≥3% (delta in mean lumen diameter) after nitroglycerin injection | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success | implantation of the intended device with attainment of <30% residual stenosis of the target lesion and TIMI ≥2 | Immediate after the procedure | 
| Procedure success | device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis | Up to 7 days | 
| Device-oriented Composite Endpoint (DOCE) | Combined of cardiac death, Target vessel MI, or clinically-indicated target lesion revascularization | 1, 6 months, 1,2,3,4,5 years | 
| Cardiac death | ARC definition | 1, 6 months, 1,2,3,4,5 years | 
| Target vessel MI | ARC definition | 1, 6 months, 1,2,3,4,5 years | 
| Clinically driven target lesion revascularization | ARC definition-Ischemia driven revascularization | 1, 6 months, 1,2,3,4,5 years | 
| Stent/scaffold thrombosis | ARC definition: definite, probable, possible, acute, subacute, late and very late | 1, 6 months, 1,2,3,4,5 years | 
| Patient oriented endpoint (POCE) | Combined of all-cause death, any repeat myocardial infarction and any revascularization | 1, 6 months, 1,2,3,4,5 years | 
| All-cause death | All-cause death rate | 1, 6 months, 1,2,3,4,5 years | 
| Any repeat myocardial infarction | According to WHO extended definition | 1, 6 months, 1,2,3,4,5 years | 
| Any revascularization | Any repeat intervention in the patient | 1, 6 months, 1,2,3,4,5 years | 
| Target lesion revascularization | ARC definition | 1, 6 months, 1,2,3,4,5 years | 
| Target vessel revascularization | ARC definition | 1, 6 months, 1,2,3,4,5 years | 
| MLD | Minimal lumen diameter by QCA | Baseline and 1 year follow-up | 
| %DS | percentage diameter stenosis by QCA | Baseline and 1 year follow-up | 
| Acute gain | MLD post - MLD pre by QCA | Baseline | 
| Late loss | MLD post - MLD at 1 year follow-up by QCA | 1 year | 
| Binary restenosis | % of patients with >50% DS at 1 year follow-up by QCA | 1 year | 
| Lumen area | Mean and minimum lumen area of the stented/scaffolded segment by OCT | 1 year follow-up | 
| Mean lumen volume | mean lumen volume of the stented/scaffolded segment by OCT | 1 year follow-up | 
| % strut malapposition | mean area of strut malapposition by OCT | 1 year follow-up | 
| Tissue Prolapse | presence and % of lumen area occupied by tissue prolapse by OCT | 1 year follow-up | 
| Neointimal hyperplasia | mean intra-stent/scaffold area occupied by neointimal hyperplasia by OCT | 1 year follow-up | 
| Healing index | Index obtained by a combination of % malapposition, % coverage, % tissue prolapse by OCT | 1 year follow-up | 
| Strut coverage | Presence and amount of tissue covering the strut of the stent/scaffold by OCT | 1 year follow-up | 
| RUTTS | Ratio of Uncovered to Total Stent/scaffold Struts Per Cross Section (RUTTS) score of ≤30% of the target stent/scaffold as determined by OCT pullback | 1 year follow-up | 
| in-stent/in-scaffold endothelium-dependent vasomotion | % change in mean luminal dimeter on the treated segment after acetylcholine infusion | at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biodegradable stent, STEMI, Magnesium bioresorbable, Vasomotion