<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03234348</url>
  </required_header>
  <id_info>
    <org_study_id>MAG-01</org_study_id>
    <nct_id>NCT03234348</nct_id>
  </id_info>
  <brief_title>MAGnesium-based Bioresorbable Scaffold in ST Segment Elevation Myocardial Infarction</brief_title>
  <acronym>MAGSTEMI</acronym>
  <official_title>MAGnesium-based Bioresorbable Scaffold and Vasomotor Function in Patients With Acute ST Segment Elevation Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spanish Society of Cardiology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Clinic of Barcelona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomized, active control, single-blind, non-inferiority, multicenter&#xD;
      clinical trial. 148 subjects will be registered at up to 10 Spanish sites. Subjects will be&#xD;
      followed for 5 years.&#xD;
&#xD;
      All eligible patients (STEMI &lt; 12 hours from onset of chest pain) will be randomized to&#xD;
&#xD;
        -  Biotronik MAGMARISTM Sirolimus Eluting Bioresorbable Vascular Scaffold System (M-BRS) or&#xD;
&#xD;
        -  Biotronik ORSIRO Sirolimus Eluting Coronary Stent System&#xD;
&#xD;
      Endothelium-independent vasomotor response (NTG injection) will be analyzed at 12 months&#xD;
      angiographic follow-up (Primary endpoint).&#xD;
&#xD;
      In a subgroup of 40 patients Optical Coherence Tomography will be performed after the&#xD;
      procedure and at 12 months follow-up.&#xD;
&#xD;
      Angiographic (QCA pre- and post-procedure and at 12 months follow-up), OCT data (at 12 months&#xD;
      follow-up) will be analyzed off-line by an independent core lab.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will be randomised to one of two groups:&#xD;
MAGMARIS stent arm or ORSIRO stent arm in the ratio of 1:1</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <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).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>In-stent/scaffold vasodilatory endothelium independent response</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>in-stent/scaffold vasodilatory response ≥3% (delta in mean lumen diameter) after nitroglycerin injection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>Immediate after the procedure</time_frame>
    <description>implantation of the intended device with attainment of &lt;30% residual stenosis of the target lesion and TIMI ≥2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure success</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device-oriented Composite Endpoint (DOCE)</measure>
    <time_frame>1, 6 months, 1,2,3,4,5 years</time_frame>
    <description>Combined of cardiac death, Target vessel MI, or clinically-indicated target lesion revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>1, 6 months, 1,2,3,4,5 years</time_frame>
    <description>ARC definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel MI</measure>
    <time_frame>1, 6 months, 1,2,3,4,5 years</time_frame>
    <description>ARC definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically driven target lesion revascularization</measure>
    <time_frame>1, 6 months, 1,2,3,4,5 years</time_frame>
    <description>ARC definition-Ischemia driven revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent/scaffold thrombosis</measure>
    <time_frame>1, 6 months, 1,2,3,4,5 years</time_frame>
    <description>ARC definition: definite, probable, possible, acute, subacute, late and very late</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient oriented endpoint (POCE)</measure>
    <time_frame>1, 6 months, 1,2,3,4,5 years</time_frame>
    <description>Combined of all-cause death, any repeat myocardial infarction and any revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death</measure>
    <time_frame>1, 6 months, 1,2,3,4,5 years</time_frame>
    <description>All-cause death rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any repeat myocardial infarction</measure>
    <time_frame>1, 6 months, 1,2,3,4,5 years</time_frame>
    <description>According to WHO extended definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any revascularization</measure>
    <time_frame>1, 6 months, 1,2,3,4,5 years</time_frame>
    <description>Any repeat intervention in the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization</measure>
    <time_frame>1, 6 months, 1,2,3,4,5 years</time_frame>
    <description>ARC definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel revascularization</measure>
    <time_frame>1, 6 months, 1,2,3,4,5 years</time_frame>
    <description>ARC definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MLD</measure>
    <time_frame>Baseline and 1 year follow-up</time_frame>
    <description>Minimal lumen diameter by QCA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%DS</measure>
    <time_frame>Baseline and 1 year follow-up</time_frame>
    <description>percentage diameter stenosis by QCA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute gain</measure>
    <time_frame>Baseline</time_frame>
    <description>MLD post - MLD pre by QCA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late loss</measure>
    <time_frame>1 year</time_frame>
    <description>MLD post - MLD at 1 year follow-up by QCA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Binary restenosis</measure>
    <time_frame>1 year</time_frame>
    <description>% of patients with &gt;50% DS at 1 year follow-up by QCA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumen area</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>Mean and minimum lumen area of the stented/scaffolded segment by OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean lumen volume</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>mean lumen volume of the stented/scaffolded segment by OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% strut malapposition</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>mean area of strut malapposition by OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tissue Prolapse</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>presence and % of lumen area occupied by tissue prolapse by OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neointimal hyperplasia</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>mean intra-stent/scaffold area occupied by neointimal hyperplasia by OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healing index</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>Index obtained by a combination of % malapposition, % coverage, % tissue prolapse by OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strut coverage</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>Presence and amount of tissue covering the strut of the stent/scaffold by OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RUTTS</measure>
    <time_frame>1 year follow-up</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>in-stent/in-scaffold endothelium-dependent vasomotion</measure>
    <time_frame>at 12 months</time_frame>
    <description>% change in mean luminal dimeter on the treated segment after acetylcholine infusion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>ST Segment Elevation Myocardial Infarction</condition>
  <condition>Stent</condition>
  <arm_group>
    <arm_group_label>Magmaris</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Percutaneous coronary intervention by means of Magnesium-based sirolimus-eluting bioresorbable scaffold implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orsiro</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Percutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous coronary intervention</intervention_name>
    <description>PCI + stent implantation</description>
    <arm_group_label>Magmaris</arm_group_label>
    <arm_group_label>Orsiro</arm_group_label>
    <other_name>stent implantation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical:&#xD;
&#xD;
          1. At least 18 years of age.&#xD;
&#xD;
          2. ST-segment elevation Myocardial Infarction documented in an ambulance or in a Cathlab,&#xD;
             with ≥2 mm ST segment elevation in at least two contiguous leads, presenting in the&#xD;
             Cathlab &lt;12 hours after the onset of symptoms lasting ≥20 min requiring primary PCI.&#xD;
&#xD;
          3. Target lesion must be a de-novo lesion located in a native vessel.&#xD;
&#xD;
          4. The patient accepts Informed Consent&#xD;
&#xD;
          5. The patient understands and accepts clinical follow-up and angiographic control.&#xD;
&#xD;
             Angiographic:&#xD;
&#xD;
          6. Vessel size should match available M-BRS scaffold sizes (≥2.75 mm, and ≤3.7 mm by&#xD;
             visual assessment).&#xD;
&#xD;
          7. Lesion preparation by either manual thrombectomy or pre-dilatation has been&#xD;
             successful, with opening of the vessel and TIMI ≥2 and residual stenosis &lt;20%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy.&#xD;
&#xD;
          2. Known intolerance to aspirin, heparin, stainless steel, sirolimus, and contrast&#xD;
             material.&#xD;
&#xD;
          3. Distal vessel occlusion after recanalization&#xD;
&#xD;
          4. STEMI due to stent/scaffold thrombosis&#xD;
&#xD;
          5. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in&#xD;
             the opinion of the investigator would result in sub-optimal m-BRS placement.&#xD;
&#xD;
          6. Fibrinolysis prior to PCI&#xD;
&#xD;
          7. Known thrombocytopenia (PLT&lt; 100,000/mm3)&#xD;
&#xD;
          8. Active bleeding or coagulopathy or patients at chronic anticoagulation therapy&#xD;
&#xD;
          9. Cardiogenic Shock&#xD;
&#xD;
         10. Significant comorbidities precluding clinical/angiographic FU (as judged by&#xD;
             investigators)&#xD;
&#xD;
         11. Major planned surgery that requires discontinuation of dual antiplatelet therapy.&#xD;
&#xD;
         12. Diffuse coronary artery disease that will require CABG&#xD;
&#xD;
         13. Chronic kidney disease with GFR&lt;30 ml/min&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manel Sabaté, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General de Alicante</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro de Alcántara</name>
      <address>
        <city>Cáceres</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Princesa</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta de Hierro Majadahonda</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Brugaletta S, Cequier A, Alfonso F, Iniguez A, Romani S, Serra A, Salinas P, Goicolea J, Bordes P, Del Blanco BG, Hernandez-Antolin R, Pernigotti A, Gomez-Lara J, Sabate M. MAGnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):64-70. doi: 10.1002/ccd.27825. Epub 2018 Sep 9.</citation>
    <PMID>30196572</PMID>
  </reference>
  <results_reference>
    <citation>Sabate M, Alfonso F, Cequier A, Romani S, Bordes P, Serra A, Iniguez A, Salinas P, Garcia Del Blanco B, Goicolea J, Hernandez-Antolin R, Cuesta J, Gomez-Hospital JA, Ortega-Paz L, Gomez-Lara J, Brugaletta S. Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial. Circulation. 2019 Dec 3;140(23):1904-1916. doi: 10.1161/CIRCULATIONAHA.119.043467. Epub 2019 Sep 25.</citation>
    <PMID>31553204</PMID>
  </results_reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>April 15, 2020</last_update_submitted>
  <last_update_submitted_qc>April 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Manel Sabate, MD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>biodegradable stent</keyword>
  <keyword>STEMI</keyword>
  <keyword>Magnesium bioresorbable</keyword>
  <keyword>Vasomotion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_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</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03234348
org study id: MAG-01
nct id: NCT03234348
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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
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).
measure: In-stent/scaffold vasodilatory endothelium independent response
time frame: 12 months follow-up
description: in-stent/scaffold vasodilatory response ≥3% (delta in mean lumen diameter) after nitroglycerin injection
measure: Device success
time frame: Immediate after the procedure
description: implantation of the intended device with attainment of <30% residual stenosis of the target lesion and TIMI ≥2
measure: Procedure success
time frame: Up to 7 days
description: device success and no in-hospital cardiac events: death, repeat MI, TVR or stent/scaffold thrombosis
measure: Device-oriented Composite Endpoint (DOCE)
time frame: 1, 6 months, 1,2,3,4,5 years
description: Combined of cardiac death, Target vessel MI, or clinically-indicated target lesion revascularization
measure: Cardiac death
time frame: 1, 6 months, 1,2,3,4,5 years
description: ARC definition
measure: Target vessel MI
time frame: 1, 6 months, 1,2,3,4,5 years
description: ARC definition
measure: Clinically driven target lesion revascularization
time frame: 1, 6 months, 1,2,3,4,5 years
description: ARC definition-Ischemia driven revascularization
measure: Stent/scaffold thrombosis
time frame: 1, 6 months, 1,2,3,4,5 years
description: ARC definition: definite, probable, possible, acute, subacute, late and very late
measure: Patient oriented endpoint (POCE)
time frame: 1, 6 months, 1,2,3,4,5 years
description: Combined of all-cause death, any repeat myocardial infarction and any revascularization
measure: All-cause death
time frame: 1, 6 months, 1,2,3,4,5 years
description: All-cause death rate
measure: Any repeat myocardial infarction
time frame: 1, 6 months, 1,2,3,4,5 years
description: According to WHO extended definition
measure: Any revascularization
time frame: 1, 6 months, 1,2,3,4,5 years
description: Any repeat intervention in the patient
measure: Target lesion revascularization
time frame: 1, 6 months, 1,2,3,4,5 years
description: ARC definition
measure: Target vessel revascularization
time frame: 1, 6 months, 1,2,3,4,5 years
description: ARC definition
measure: MLD
time frame: Baseline and 1 year follow-up
description: Minimal lumen diameter by QCA
measure: %DS
time frame: Baseline and 1 year follow-up
description: percentage diameter stenosis by QCA
measure: Acute gain
time frame: Baseline
description: MLD post - MLD pre by QCA
measure: Late loss
time frame: 1 year
description: MLD post - MLD at 1 year follow-up by QCA
measure: Binary restenosis
time frame: 1 year
description: % of patients with >50% DS at 1 year follow-up by QCA
measure: Lumen area
time frame: 1 year follow-up
description: Mean and minimum lumen area of the stented/scaffolded segment by OCT
measure: Mean lumen volume
time frame: 1 year follow-up
description: mean lumen volume of the stented/scaffolded segment by OCT
measure: % strut malapposition
time frame: 1 year follow-up
description: mean area of strut malapposition by OCT
measure: Tissue Prolapse
time frame: 1 year follow-up
description: presence and % of lumen area occupied by tissue prolapse by OCT
measure: Neointimal hyperplasia
time frame: 1 year follow-up
description: mean intra-stent/scaffold area occupied by neointimal hyperplasia by OCT
measure: Healing index
time frame: 1 year follow-up
description: Index obtained by a combination of % malapposition, % coverage, % tissue prolapse by OCT
measure: Strut coverage
time frame: 1 year follow-up
description: Presence and amount of tissue covering the strut of the stent/scaffold by OCT
measure: RUTTS
time frame: 1 year follow-up
description: 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
measure: in-stent/in-scaffold endothelium-dependent vasomotion
time frame: at 12 months
description: % change in mean luminal dimeter on the treated segment after acetylcholine infusion
arm group label: Magmaris
arm group type: Experimental
description: Percutaneous coronary intervention by means of Magnesium-based sirolimus-eluting bioresorbable scaffold implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.
arm group label: Orsiro
arm group type: Placebo Comparator
description: Percutaneous coronary intervention by means of Biodegradable polymer sirolimus-eluting stent implantation after proper lesion preparation by balloon predilatation and/or manual thrombectomy.
intervention type: Device
intervention name: Percutaneous coronary intervention
description: PCI + stent implantation
arm group label: Magmaris
arm group label: Orsiro
other name: stent implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Manel Sabaté, MD
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
facility: 
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country: Spain
citation: Brugaletta S, Cequier A, Alfonso F, Iniguez A, Romani S, Serra A, Salinas P, Goicolea J, Bordes P, Del Blanco BG, Hernandez-Antolin R, Pernigotti A, Gomez-Lara J, Sabate M. MAGnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):64-70. doi: 10.1002/ccd.27825. Epub 2018 Sep 9.
PMID: 30196572
citation: Sabate M, Alfonso F, Cequier A, Romani S, Bordes P, Serra A, Iniguez A, Salinas P, Garcia Del Blanco B, Goicolea J, Hernandez-Antolin R, Cuesta J, Gomez-Hospital JA, Ortega-Paz L, Gomez-Lara J, Brugaletta S. Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial. Circulation. 2019 Dec 3;140(23):1904-1916. doi: 10.1161/CIRCULATIONAHA.119.043467. Epub 2019 Sep 25.
PMID: 31553204
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Manel Sabate, MD
investigator title: MD, PhD
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: Yes
ipd 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
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd 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