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MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction (MAGSTEMI)

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ClinicalTrials.gov Identifier: NCT03234348
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
Spanish Society of Cardiology
Information provided by (Responsible Party):
Manel Sabate, MD, Hospital Clinic of Barcelona

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome ST Segment Elevation Myocardial Infarction Stent Device: Percutaneous coronary intervention Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be randomised to one of two groups:

MAGMARIS stent arm or ORSIRO stent arm in the ratio of 1:1

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).
Primary Purpose: Treatment
Official Title: MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Magnesium

Arm Intervention/treatment
Experimental: 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.
Device: Percutaneous coronary intervention
PCI + stent implantation
Other Name: stent implantation

Placebo Comparator: Orsiro
Percutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.
Device: Percutaneous coronary intervention
PCI + stent implantation
Other Name: stent implantation




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Device success [ Time Frame: Immediate after the procedure ]
    implantation of the intended device with attainment of <30% residual stenosis of the target lesion and TIMI ≥2

  2. Procedure success [ Time Frame: Up to 7 days ]
    device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis

  3. Device-oriented Composite Endpoint (DOCE) [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    Combined of cardiac death, Target vessel MI, or clinically-indicated target lesion revascularization

  4. Cardiac death [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    ARC definition

  5. Target vessel MI [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    ARC definition

  6. Clinically driven target lesion revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    ARC definition-Ischemia driven revascularization

  7. Stent/scaffold thrombosis [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    ARC definition: definite, probable, possible, acute, subacute, late and very late

  8. Patient oriented endpoint (POCE) [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    Combined of all-cause death, any repeat myocardial infarction and any revascularization

  9. All-cause death [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    All-cause death rate

  10. Any repeat myocardial infarction [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    According to WHO extended definition

  11. Any revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    Any repeat intervention in the patient

  12. Target lesion revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    ARC definition

  13. Target vessel revascularization [ Time Frame: 1, 6 months, 1,2,3,4,5 years ]
    ARC definition

  14. MLD [ Time Frame: Baseline and 1 year follow-up ]
    Minimal lumen diameter by QCA

  15. %DS [ Time Frame: Baseline and 1 year follow-up ]
    percentage diameter stenosis by QCA

  16. Acute gain [ Time Frame: Baseline ]
    MLD post - MLD pre by QCA

  17. Late loss [ Time Frame: 1 year ]
    MLD post - MLD at 1 year follow-up by QCA

  18. Binary restenosis [ Time Frame: 1 year ]
    % of patients with >50% DS at 1 year follow-up by QCA

  19. Lumen area [ Time Frame: 1 year follow-up ]
    Mean and minimum lumen area of the stented/scaffolded segment by OCT

  20. Mean lumen volume [ Time Frame: 1 year follow-up ]
    mean lumen volume of the stented/scaffolded segment by OCT

  21. % strut malapposition [ Time Frame: 1 year follow-up ]
    mean area of strut malapposition by OCT

  22. Tissue Prolapse [ Time Frame: 1 year follow-up ]
    presence and % of lumen area occupied by tissue prolapse by OCT

  23. Neointimal hyperplasia [ Time Frame: 1 year follow-up ]
    mean intra-stent/scaffold area occupied by neointimal hyperplasia by OCT

  24. Healing index [ Time Frame: 1 year follow-up ]
    Index obtained by a combination of % malapposition, % coverage, % tissue prolapse by OCT

  25. Strut coverage [ Time Frame: 1 year follow-up ]
    Presence and amount of tissue covering the strut of the stent/scaffold by OCT

  26. RUTTS [ Time Frame: 1 year follow-up ]
    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

  27. in-stent/in-scaffold endothelium-dependent vasomotion [ Time Frame: at 12 months ]
    % change in mean luminal dimeter on the treated segment after acetylcholine infusion



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234348


Locations
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Spain
Hospital General de Alicante
Alicante, Spain
Hospital Clínic
Barcelona, Spain, 08036
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, Spain
Sponsors and Collaborators
Hospital Clinic of Barcelona
Spanish Society of Cardiology
Investigators
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Principal Investigator: Manel Sabaté, MD Hospital Clinic of Barcelona
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manel Sabate, MD, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03234348    
Other Study ID Numbers: MAG-01
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data on primary/secondary outcomes on individual basis may be shared with other researchers once main report as been published and review and approval of the research proposal by the steering committee of the Magstemi Trial
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data on primary/secondary outcomes on individual basis may be shared with other researchers once main report as been published and review and approval of the research proposal by the steering committee of the Magstemi Trial

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manel Sabate, MD, Hospital Clinic of Barcelona:
biodegradable stent
STEMI
Magnesium bioresorbable
Vasomotion
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases