MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction (MAGSTEMI)
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ClinicalTrials.gov Identifier: NCT03234348 |
Recruitment Status :
Completed
First Posted : July 31, 2017
Last Update Posted : April 17, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
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Acute Coronary Syndrome ST Segment Elevation Myocardial Infarction Stent | Device: Percutaneous coronary intervention | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 151 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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 (Participant, Outcomes Assessor) |
Masking Description: | Neither the participant ot the outcomes assessor will be aware of the treatment received. The patient will be blinded until the primary endpoint is reached (1 year follow-up). |
Primary Purpose: | Treatment |
Official Title: | MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction |
Actual Study Start Date : | July 1, 2017 |
Actual Primary Completion Date : | June 30, 2019 |
Actual Study Completion Date : | October 31, 2019 |

Arm | Intervention/treatment |
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Experimental: Magmaris
Percutaneous coronary intervention by means of Magnesium-based sirolimus-eluting bioresorbable scaffold implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.
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Device: Percutaneous coronary intervention
PCI + stent implantation
Other Name: stent implantation |
Placebo Comparator: Orsiro
Percutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.
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Device: Percutaneous coronary intervention
PCI + stent implantation
Other Name: stent implantation |
- In-stent/scaffold vasodilatory endothelium independent response [ Time Frame: 12 months follow-up ]in-stent/scaffold vasodilatory response ≥3% (delta in mean lumen diameter) after nitroglycerin injection
- Device success [ Time Frame: Immediate after the procedure ]implantation of the intended device with attainment of <30% residual stenosis of the target lesion and TIMI ≥2
- Procedure success [ Time Frame: Up to 7 days ]device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis
- Device-oriented Composite Endpoint (DOCE) [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]Combined of cardiac death, Target vessel MI, or clinically-indicated target lesion revascularization
- Cardiac death [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]ARC definition
- Target vessel MI [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]ARC definition
- Clinically driven target lesion revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]ARC definition-Ischemia driven revascularization
- Stent/scaffold thrombosis [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]ARC definition: definite, probable, possible, acute, subacute, late and very late
- Patient oriented endpoint (POCE) [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]Combined of all-cause death, any repeat myocardial infarction and any revascularization
- All-cause death [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]All-cause death rate
- Any repeat myocardial infarction [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]According to WHO extended definition
- Any revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]Any repeat intervention in the patient
- Target lesion revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]ARC definition
- Target vessel revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]ARC definition
- MLD [ Time Frame: Baseline and 1 year follow-up ]Minimal lumen diameter by QCA
- %DS [ Time Frame: Baseline and 1 year follow-up ]percentage diameter stenosis by QCA
- Acute gain [ Time Frame: Baseline ]MLD post - MLD pre by QCA
- Late loss [ Time Frame: 1 year ]MLD post - MLD at 1 year follow-up by QCA
- Binary restenosis [ Time Frame: 1 year ]% of patients with >50% DS at 1 year follow-up by QCA
- Lumen area [ Time Frame: 1 year follow-up ]Mean and minimum lumen area of the stented/scaffolded segment by OCT
- Mean lumen volume [ Time Frame: 1 year follow-up ]mean lumen volume of the stented/scaffolded segment by OCT
- % strut malapposition [ Time Frame: 1 year follow-up ]mean area of strut malapposition by OCT
- Tissue Prolapse [ Time Frame: 1 year follow-up ]presence and % of lumen area occupied by tissue prolapse by OCT
- Neointimal hyperplasia [ Time Frame: 1 year follow-up ]mean intra-stent/scaffold area occupied by neointimal hyperplasia by OCT
- Healing index [ Time Frame: 1 year follow-up ]Index obtained by a combination of % malapposition, % coverage, % tissue prolapse by OCT
- Strut coverage [ Time Frame: 1 year follow-up ]Presence and amount of tissue covering the strut of the stent/scaffold by OCT
- RUTTS [ Time Frame: 1 year follow-up ]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
- in-stent/in-scaffold endothelium-dependent vasomotion [ Time Frame: at 12 months ]% change in mean luminal dimeter on the treated segment after acetylcholine infusion

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234348
Spain | |
Hospital General de Alicante | |
Alicante, Spain | |
Hospital Clínic | |
Barcelona, Spain, 08036 | |
Hospital Sant Pau | |
Barcelona, Spain | |
Hospital Universitari Bellvitge | |
Barcelona, Spain | |
Hospital Vall d'Hebron | |
Barcelona, Spain | |
Hospital San Pedro de Alcántara | |
Cáceres, Spain | |
Hospital Clínico San Carlos | |
Madrid, Spain | |
Hospital La Princesa | |
Madrid, Spain | |
Hospital Puerta de Hierro Majadahonda | |
Madrid, Spain | |
Hospital Ramon y Cajal | |
Madrid, Spain | |
Hospital Alvaro Cunqueiro | |
Vigo, Spain |
Principal Investigator: | Manel Sabaté, MD | Hospital Clinic of Barcelona |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Manel Sabate, MD, MD, PhD, Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT03234348 |
Other Study ID Numbers: |
MAG-01 |
First Posted: | July 31, 2017 Key Record Dates |
Last Update Posted: | April 17, 2020 |
Last Verified: | April 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data on primary/secondary outcomes on individual basis may be shared with other researchers once main report as been published and review and approval of the research proposal by the steering committee of the Magstemi Trial |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data on primary/secondary outcomes on individual basis may be shared with other researchers once main report as been published and review and approval of the research proposal by the steering committee of the Magstemi Trial |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
biodegradable stent STEMI Magnesium bioresorbable Vasomotion |
Myocardial Infarction Acute Coronary Syndrome ST Elevation Myocardial Infarction Infarction Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |