MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction

Hospital Clinic of Barcelona151 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

151

Conditions

Acute Coronary Syndrome ST Segment Elevation Myocardial Infarction Stent

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (11)

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

...and 1 more locations

Outcomes

Primary Outcomes

In-stent/scaffold vasodilatory endothelium independent response

in-stent/scaffold vasodilatory response ≥3% (delta in mean lumen diameter) after nitroglycerin injection

Time frame: 12 months follow-up

Secondary Outcomes

Device success

implantation of the intended device with attainment of \<30% residual stenosis of the target lesion and TIMI ≥2

Time frame: Immediate after the procedure

Procedure success

device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis

Time frame: Up to 7 days

Device-oriented Composite Endpoint (DOCE)

Combined of cardiac death, Target vessel MI, or clinically-indicated target lesion revascularization