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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.
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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
Primary purpose
Allocation
Interventional model
Masking
151 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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