MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 151
- Locations
- 11
- Primary Endpoint
- In-stent/scaffold vasodilatory endothelium independent response
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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).
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Arms & Interventions
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.
Intervention: Percutaneous coronary intervention (Device)
Orsiro
Percutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.
Intervention: Percutaneous coronary intervention (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Late loss(1 year)
- Target vessel revascularization(1, 6 months, 1,2,3,4,5 years)
- Tissue Prolapse(1 year follow-up)
- Procedure success(Up to 7 days)
- Cardiac death(1, 6 months, 1,2,3,4,5 years)
- Target vessel MI(1, 6 months, 1,2,3,4,5 years)
- Clinically driven target lesion revascularization(1, 6 months, 1,2,3,4,5 years)
- % strut malapposition(1 year follow-up)
- Device success(Immediate after the procedure)
- Patient oriented endpoint (POCE)(1, 6 months, 1,2,3,4,5 years)
- Acute gain(Baseline)
- Binary restenosis(1 year)
- Mean lumen volume(1 year follow-up)
- Neointimal hyperplasia(1 year follow-up)
- RUTTS(1 year follow-up)
- Stent/scaffold thrombosis(1, 6 months, 1,2,3,4,5 years)
- All-cause death(1, 6 months, 1,2,3,4,5 years)
- Any repeat myocardial infarction(1, 6 months, 1,2,3,4,5 years)
- Target lesion revascularization(1, 6 months, 1,2,3,4,5 years)
- Lumen area(1 year follow-up)
- Device-oriented Composite Endpoint (DOCE)(1, 6 months, 1,2,3,4,5 years)
- Any revascularization(1, 6 months, 1,2,3,4,5 years)
- MLD(Baseline and 1 year follow-up)
- %DS(Baseline and 1 year follow-up)
- Strut coverage(1 year follow-up)
- in-stent/in-scaffold endothelium-dependent vasomotion(at 12 months)
- Healing index(1 year follow-up)
Investigators
Manel Sabate, MD
MD, PhD
Hospital Clinic of Barcelona