MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction
NCT ID: NCT03234348
Last Updated: 2020-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
151 participants
INTERVENTIONAL
2017-07-01
2019-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
MAGMARIS stent arm or ORSIRO stent arm in the ratio of 1:1
TREATMENT
DOUBLE
Study Groups
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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.
Percutaneous coronary intervention
PCI + stent implantation
Orsiro
Percutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.
Percutaneous coronary intervention
PCI + stent implantation
Interventions
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Percutaneous coronary intervention
PCI + stent implantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. At least 18 years of age.
2. 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.
3. Target lesion must be a de-novo lesion located in a native vessel.
4. The patient accepts Informed Consent
5. The patient understands and accepts clinical follow-up and angiographic control.
Angiographic:
6. Vessel size should match available M-BRS scaffold sizes (≥2.75 mm, and ≤3.7 mm by visual assessment).
7. 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
2. Known intolerance to aspirin, heparin, stainless steel, sirolimus, and contrast material.
3. Distal vessel occlusion after recanalization
4. STEMI due to stent/scaffold thrombosis
5. 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.
6. Fibrinolysis prior to PCI
7. Known thrombocytopenia (PLT\< 100,000/mm3)
8. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
9. Cardiogenic Shock
10. Significant comorbidities precluding clinical/angiographic FU (as judged by investigators)
11. Major planned surgery that requires discontinuation of dual antiplatelet therapy.
12. Diffuse coronary artery disease that will require CABG
13. Chronic kidney disease with GFR\<30 ml/min
18 Years
90 Years
ALL
No
Sponsors
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Spanish Society of Cardiology
OTHER
Hospital Clinic of Barcelona
OTHER
Responsible Party
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Manel Sabate, MD
MD, PhD
Principal Investigators
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Manel Sabaté, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital General de Alicante
Alicante, , Spain
Hospital Clínic
Barcelona, , Spain
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
Countries
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References
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Brugaletta S, Cequier A, Alfonso F, Iniguez A, Romani S, Serra A, Salinas P, Goicolea J, Bordes P, Del Blanco BG, Hernandez-Antolin R, Pernigotti A, Gomez-Lara J, Sabate M. MAGnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):64-70. doi: 10.1002/ccd.27825. Epub 2018 Sep 9.
Sabate M, Alfonso F, Cequier A, Romani S, Bordes P, Serra A, Iniguez A, Salinas P, Garcia Del Blanco B, Goicolea J, Hernandez-Antolin R, Cuesta J, Gomez-Hospital JA, Ortega-Paz L, Gomez-Lara J, Brugaletta S. Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial. Circulation. 2019 Dec 3;140(23):1904-1916. doi: 10.1161/CIRCULATIONAHA.119.043467. Epub 2019 Sep 25.
Gomez-Lara J, Ortega-Paz L, Brugaletta S, Cuesta J, Romani S, Serra A, Salinas P, Garcia Del Blanco B, Goicolea J, Hernandez-Antolin R, Antuna P, Romaguera R, Regueiro A, Rivero F, Cequier A, Alfonso F, Gomez-Hospital JA, Sabate M; Collaborators. Bioresorbable scaffolds versus permanent sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction: vascular healing outcomes from the MAGSTEMI trial. EuroIntervention. 2020 Dec 4;16(11):e913-e921. doi: 10.4244/EIJ-D-20-00198.
Other Identifiers
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MAG-01
Identifier Type: -
Identifier Source: org_study_id
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