Status:
COMPLETED
MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Spanish Society of Cardiology
Conditions:
Acute Coronary Syndrome
ST Segment Elevation Myocardial Infarction
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- Pregnancy.
- 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
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT03234348
Start Date
July 1 2017
End Date
October 31 2019
Last Update
April 17 2020
Active Locations (11)
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1
Hospital General de Alicante
Alicante, Spain
2
Hospital Clínic
Barcelona, Spain, 08036
3
Hospital Sant Pau
Barcelona, Spain
4
Hospital Universitari Bellvitge
Barcelona, Spain