Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Spanish Society of Cardiology | OTHER |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magmaris | Experimental | Percutaneous coronary intervention by means of Magnesium-based sirolimus-eluting bioresorbable scaffold implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy. |
|
| Orsiro | Placebo Comparator | Percutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention | Device | PCI + stent implantation |
|
| 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 |
| 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 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Manel Sabaté, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Alicante | Alicante | Spain | ||||
| Hospital Clínic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30196572 | Background | 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. | |
| 31553204 |
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Patients will be randomised to one of two groups:
MAGMARIS stent arm or ORSIRO stent arm in the ratio of 1:1
Not provided
Not provided
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).
| 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 |
| Barcelona |
| 08036 |
| 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 |
| Result |
| 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. |
| 32310130 | Derived | 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. |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided