Acute Coronary Syndrome Clinical Trial
— MAGSTEMIOfficial title:
MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction
Verified date | April 2020 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 151 |
Est. completion date | October 31, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: Clinical: 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: 1. Pregnancy. 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 |
Country | Name | City | State |
---|---|---|---|
Spain | 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 |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | Spanish Society of Cardiology |
Spain,
Brugaletta S, Cequier A, Alfonso F, Iñiguez A, Romaní S, Serra A, Salinas P, Goicolea J, Bordes P, Del Blanco BG, Hernández-Antolín R, Pernigotti A, Gómez-Lara J, Sabaté 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. — View Citation
Sabaté M, Alfonso F, Cequier A, Romaní S, Bordes P, Serra A, Iñiguez A, Salinas P, García Del Blanco B, Goicolea J, Hernández-Antolín R, Cuesta J, Gómez-Hospital JA, Ortega-Paz L, Gomez-Lara J, Brugaletta S. Magnesium-Based Resorbable Scaffold Versus Perm — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Device success | implantation of the intended device with attainment of <30% residual stenosis of the target lesion and TIMI =2 | Immediate after the procedure | |
Secondary | Procedure success | device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis | Up to 7 days | |
Secondary | 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 | |
Secondary | Cardiac death | ARC definition | 1, 6 months, 1,2,3,4,5 years | |
Secondary | Target vessel MI | ARC definition | 1, 6 months, 1,2,3,4,5 years | |
Secondary | Clinically driven target lesion revascularization | ARC definition-Ischemia driven revascularization | 1, 6 months, 1,2,3,4,5 years | |
Secondary | Stent/scaffold thrombosis | ARC definition: definite, probable, possible, acute, subacute, late and very late | 1, 6 months, 1,2,3,4,5 years | |
Secondary | 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 | |
Secondary | All-cause death | All-cause death rate | 1, 6 months, 1,2,3,4,5 years | |
Secondary | Any repeat myocardial infarction | According to WHO extended definition | 1, 6 months, 1,2,3,4,5 years | |
Secondary | Any revascularization | Any repeat intervention in the patient | 1, 6 months, 1,2,3,4,5 years | |
Secondary | Target lesion revascularization | ARC definition | 1, 6 months, 1,2,3,4,5 years | |
Secondary | Target vessel revascularization | ARC definition | 1, 6 months, 1,2,3,4,5 years | |
Secondary | MLD | Minimal lumen diameter by QCA | Baseline and 1 year follow-up | |
Secondary | %DS | percentage diameter stenosis by QCA | Baseline and 1 year follow-up | |
Secondary | Acute gain | MLD post - MLD pre by QCA | Baseline | |
Secondary | Late loss | MLD post - MLD at 1 year follow-up by QCA | 1 year | |
Secondary | Binary restenosis | % of patients with >50% DS at 1 year follow-up by QCA | 1 year | |
Secondary | Lumen area | Mean and minimum lumen area of the stented/scaffolded segment by OCT | 1 year follow-up | |
Secondary | Mean lumen volume | mean lumen volume of the stented/scaffolded segment by OCT | 1 year follow-up | |
Secondary | % strut malapposition | mean area of strut malapposition by OCT | 1 year follow-up | |
Secondary | Tissue Prolapse | presence and % of lumen area occupied by tissue prolapse by OCT | 1 year follow-up | |
Secondary | Neointimal hyperplasia | mean intra-stent/scaffold area occupied by neointimal hyperplasia by OCT | 1 year follow-up | |
Secondary | Healing index | Index obtained by a combination of % malapposition, % coverage, % tissue prolapse by OCT | 1 year follow-up | |
Secondary | Strut coverage | Presence and amount of tissue covering the strut of the stent/scaffold by OCT | 1 year follow-up | |
Secondary | 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 | |
Secondary | in-stent/in-scaffold endothelium-dependent vasomotion | % change in mean luminal dimeter on the treated segment after acetylcholine infusion | at 12 months |
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