<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/NCT03773081</url>
  </required_header>
  <id_info>
    <org_study_id>4.1</org_study_id>
    <nct_id>NCT03773081</nct_id>
  </id_info>
  <brief_title>SOLVE-ACS: Bioresorbable Magnesium-Stents Magmaris in ACS Lesions</brief_title>
  <acronym>SOLVE-ACS</acronym>
  <official_title>SOLVE-ACS: Prospective Multicenter Evaluation of the Performance of the Bioresorbable Magnesium-Stents Magmaris in Patients With Acute Coronary Syndrome (ACS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</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>
      The aim of the registry is to investigate the clinical performance of the Magmaris Magnesium&#xD;
      Stent in STE-ACS and NSTE-ACS patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Magmaris Magnesium-Stent is indicated for improving luminal diameter and stabilize&#xD;
      culprit lesions in patients with coronary artery disease (CAD) including ST-segment elevation&#xD;
      (STE-) as well as Non-ST-segment elevation (NSTE-) acute coronary syndrome (ACS). Patients&#xD;
      scheduled for this registry, must have one angiographic clear detectable ACS-causing culprit&#xD;
      lesion with a reference diameter and a lesion length, which closely match the nominal&#xD;
      Magmaris reference diameter and length.&#xD;
&#xD;
      Primary endpoint will be the procedural angiographical success at the end of PCI, defined as&#xD;
      successful Magmaris implantation at the &quot;culprit lesion site&quot; with less than 30% final&#xD;
      stenosis (by visual estimation) and distal TIMI 3 flow. Secondary endpoints will include&#xD;
      clinical and angiographic parameters as well as parameters gained through OCT-imaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low recruitment rate&#xD;
  </why_stopped>
  <start_date type="Actual">August 21, 2018</start_date>
  <completion_date type="Actual">September 15, 2019</completion_date>
  <primary_completion_date type="Actual">September 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedural angiographical success</measure>
    <time_frame>At the end of PCI</time_frame>
    <description>Procedural angiographical success at the end of PCI, defined as successful Magmaris implantation at the &quot;culprit lesion site&quot; with less than 30% final stenosis (by visual estimation) and distal TIMI 3 flow.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ST-segment resolution at the electrocardiogram (ECG)</measure>
    <time_frame>Within 60 minutes of primary PCI</time_frame>
    <description>ST-segment resolution at ECG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural clinical success within hospital stay</measure>
    <time_frame>Until hospital discharge, an expected average of 4 days</time_frame>
    <description>No in-hospital clinically-driven target lesion revascularization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization</measure>
    <time_frame>6 months, 12 months and 2 years</time_frame>
    <description>Clinical driven target-lesion revascularization with the use of either PCI or CABG at 6 months, 12 months and at 2 years follow-up respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device-oriented composite endpoint (DOCE)</measure>
    <time_frame>6 months, 12 months and 2 years</time_frame>
    <description>Device-oriented composite (DOCE) endpoint of cardiac death, target vessel-related reinfarction and ischemia-driven target-lesion revascularization at 6 months, 12 months and at 2 years follow-up respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events (MACE)</measure>
    <time_frame>Until hospital discharge, 6 months, 12 months and 2 years</time_frame>
    <description>Cardiac death, any TV-MI, target vessel revascularization (TVR) in-hospital or during follow-up (6 months, 12 months, 2 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death at all time points</measure>
    <time_frame>Until hospital discharge, 6 months, 12 months and 2 years</time_frame>
    <description>Clinical Endpoint (in-hospital and at follow-up (6 months, 12 months, 2 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death at all time points</measure>
    <time_frame>Until hospital discharge, 6 months, 12 months and 2 years</time_frame>
    <description>Clinical Endpoint (in-hospital and at follow-up (6 months, 12 months, 2 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magmaris Thrombosis</measure>
    <time_frame>Until hospital discharge, 6 months, 12 months and 2 years</time_frame>
    <description>Any definite/probable per ARC defintion Magmaris thrombosis (in-hospital and during follow-up (6 months, 12 months, 2 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any Bleeding</measure>
    <time_frame>Until hospital discharge, 6 months, 12 months and 2 years</time_frame>
    <description>Bleedings defined according to the Bleeding Academic Research Consortium (BARC) in-hospital and at follow-up (in-hospital and at follow-up (6 months, 12 months, 2 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular cerebral events</measure>
    <time_frame>Until hospital discharge, 6 months, 12 months and 2 years</time_frame>
    <description>Vascular events documented by neurological permanent disabilities or by diagnostic imaging (MRI or CT) in-hospital and during follow-up (6 months, 12 months, 2 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stable angina</measure>
    <time_frame>6 months, 12 months and 2 years</time_frame>
    <description>Angina as assessed by Seattle angina score (SAS) at follow-up (6 months, 12 months, 2 years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence for myocardial ischemia</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical or ECG-signs for myocardial ischemia during exercise ECG at 12-month follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent diameter stenosis</measure>
    <time_frame>24 months</time_frame>
    <description>Percent diameter stenosis (%DS) at in in-segment (target lesion), in-device, proximal and distal (initial and in case of clinical-indicated re-angiography) (assessed by outcome-blinded Corelab analyses, Charite).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal Lumen Diameter (MLD)</measure>
    <time_frame>24 months</time_frame>
    <description>Minimal Lumen Diameter in-segment (target lesion), in-device, proximal and distal (initial and in case of clinical-indicated re-angiography) (assessed by outcome-blinded Corelab analyses, Charite).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TIMI-flow</measure>
    <time_frame>24 month</time_frame>
    <description>TIMI-flow before (after mechanical recanalization) and after Magmaris Implantation (assessed by outcome-blinded Corelab analyses, Charite).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACS-causing &quot;culprit lesion&quot; (OCT)</measure>
    <time_frame>24 months</time_frame>
    <description>Mechanism of ACS (Plaque-Rupture vs. Plaque-Erosion vs. other mechanisms) and culprit-plaque-characteristics (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Max/Mean/minimal Mg-Stent diameter/area after implantation and lumen late loss (OCT)</measure>
    <time_frame>24 months</time_frame>
    <description>Max/Mean/minimal Mg-Stent diameter/area after implantation and (in case of any clinical indicated re-angiography) lumen late loss as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean/minimal lumen diameter/area/volume</measure>
    <time_frame>24 months</time_frame>
    <description>Mean/minimal lumen diameter/area/volume within the target lesion before and after Magmaris-Implantation, as well as (in case of any clinical indicated re-angiography) as difference Re-OCT to baseline-OCT (after Magmaris Implantation) (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean/minimal flow-area/volume</measure>
    <time_frame>24 months</time_frame>
    <description>Mean/minimal flow-area/volume as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraluminal defect area/volume</measure>
    <time_frame>24 months</time_frame>
    <description>Intraluminal defect area/volume at time point re-angiography/Re-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified vascular healing score</measure>
    <time_frame>24 months</time_frame>
    <description>Modified vascular healing score (%HS; according to Räber EuroIntervention 2016; Sabate + Joner EHJ 2016) as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of both malapposed and uncovered struts</measure>
    <time_frame>24 months</time_frame>
    <description>Presence of both malapposed and uncovered struts (%MN) of the Mg-stent, which is an individual component of the endpoint &quot;Healing Score&quot; as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of uncovered struts alone</measure>
    <time_frame>24 months</time_frame>
    <description>Presence of both uncovered struts of the Mg-stent, which is an individual component of the endpoint &quot;Healing Score&quot; as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of malapposed struts alone</measure>
    <time_frame>24 months</time_frame>
    <description>Presence of both malapposed struts of the Mg-stent which is an individual component of the endpoint &quot;Healing Score&quot; as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incomplete strut apposition (ISA) area/volume</measure>
    <time_frame>24 months</time_frame>
    <description>Incomplete strut apposition (ISA) area/volume as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of covered struts</measure>
    <time_frame>24 months</time_frame>
    <description>Percentage of covered struts at Re-OCT follow-up (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean/maximal thickness of the struts coverage</measure>
    <time_frame>24 months</time_frame>
    <description>Mean/maximal thickness of the struts coverage at Re-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neointimal hyperplasia area/volume</measure>
    <time_frame>24 months</time_frame>
    <description>Neointimal hyperplasia area/volume at Re-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thickness of neointimal tissue developed over lipid rich plaque</measure>
    <time_frame>24 months</time_frame>
    <description>Thickness of neointimal tissue developed over lipid rich plaque at Re-OCT follow-up (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG determination (MCG-substudy)</measure>
    <time_frame>24 months</time_frame>
    <description>Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG determination (ST-T Score (Angle dynamic), ST-T-analysis (distance parameter and rato-dynamics), PLP2 Score, VMCG Score (T-begin till Tmax and RP ½ till Tmax), T-dispersion Score) for the vessel with target lesion compared to angiography at ACS. A comparison to exercise-ECG at 12 months will also be performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG Determination (MCG-substudy)</measure>
    <time_frame>24 months</time_frame>
    <description>Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios)of MCG determination (ST-T Score (Angle dynamic), ST-T-analysis (distance parameter and rato-dynamics) PLP2 Score, VMCG Score (T-begin till Tmax and RP ½ till Tmax), T-dispersion Score) for characteristics of the ACS-causing &quot;culprit lesion&quot; compared to OCT before Magmaris-Implantation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>STEMI - ST Elevation Myocardial Infarction</condition>
  <condition>NSTEMI - Non-ST Segment Elevation MI</condition>
  <arm_group>
    <arm_group_label>Magmaris implantation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will undergo a PCI for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation of the Magmaris scaffold</intervention_name>
    <description>Subjects will undergo a PCI for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice. Maximum of one single ACS-causing de novo lesions in one separate major epicardial vessels is allowed.</description>
    <arm_group_label>Magmaris implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients of 18 - 70 years of age&#xD;
&#xD;
          -  STE- or NSTE-ACS with planned invasive therapy strategy&#xD;
&#xD;
          -  At least coronary one-vessel disease with one angiographically detectable &quot;culprit&#xD;
             lesion&quot;&#xD;
&#xD;
          -  Target lesion length ≤ 21 mm and its diameter is ≥ 2.7mm and ≤ 3.7 mm by QCA or by&#xD;
             visual estimation.&#xD;
&#xD;
          -  Subject is eligible for Dual Anti Platelet Therapy (DAPT) for 12 months after ACS&#xD;
&#xD;
        Additional inclusion criteria MCG-substudy:&#xD;
&#xD;
          -  Hospitalization for NSTE- ACS in low- and/or risk-class (GRACE-Score ≤ 170) with&#xD;
             planned invasive therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently participating within a FIM or RCT and primary endpoint is not reached yet.&#xD;
&#xD;
          -  Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, ticlopidine, prasugrel,&#xD;
             heparin or any other anticoagulant /antiplatelet required for PCI, contrast medium,&#xD;
             sirolimus, or similar drugs or the Magmaris materials including Magnesium, Yttrium,&#xD;
             Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum that cannot be adequately&#xD;
             pre-medicated.&#xD;
&#xD;
          -  Renal insufficiency with serum-creatinine ≥ 2.5 mg/dl or subjects on dialysis.&#xD;
&#xD;
          -  Known systolic heart failure with left-ventricular ejection fraction (LV-EF≤ 30 %).&#xD;
&#xD;
          -  Active sepsis.&#xD;
&#xD;
          -  Presence of cardiogenic shock or heart failure requiring intubation, inotropes,&#xD;
             intravenous diuretics or mechanical circulation support.&#xD;
&#xD;
          -  Refractory ventricular arrhythmia requiring pharmacologic or defibrillator therapy.&#xD;
&#xD;
          -  Patients under immunosuppressive therapy.&#xD;
&#xD;
          -  Unprotected significant left main- stenosis.&#xD;
&#xD;
          -  ACS with culprit lesion in a bypass graft or ACS caused by stent/BVS-thrombosis or&#xD;
             stent/BVS-restenosis.&#xD;
&#xD;
          -  ACS caused by left main coronary artery disease or an ostial target lesion (within 5.0&#xD;
             mm of vessel origin).&#xD;
&#xD;
          -  Culprit lesion involves a side branch ≥2.0 mm in diameter (bifurcation lesion).&#xD;
&#xD;
          -  Culprit lesion located within a true vessel bifurcation (including side branch &gt; 2mm)&#xD;
             which requires bifurcation-treatment according to the investigator's discretion.&#xD;
&#xD;
          -  Extent and severity of CAD is such that investigator believes it is likely that bypass&#xD;
             surgery will be required within 1 year of enrollment.&#xD;
&#xD;
          -  Severe calcification or extreme tortuosity of vessel with &quot;culprit lesion&quot;.&#xD;
&#xD;
          -  Culprit lesion with very distal location.&#xD;
&#xD;
          -  Culprit vessels with &quot;low or no-reflow phenomenon&quot; (TIMI 0,I,II) after mechanical&#xD;
             recanalization or pre-dilatation using a non-compliant balloon with 1:1&#xD;
             balloon-to-artery ratio.&#xD;
&#xD;
          -  Culprit lesions with a length ≥ 21 mm or within vessels with reference diameter≤ 2.7mm&#xD;
             or ≥ 3.7 mm by QCA or by visual estimation.&#xD;
&#xD;
          -  Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the&#xD;
             respective crossing profile of Magmaris and angiographic complications (e.g. distal&#xD;
             embolization, side branch closure, extensive dissections), by visual estimation.&#xD;
&#xD;
        Additional exclusion criteria MCG-substudy:&#xD;
&#xD;
          -  Non-MCG-safe metal implants&#xD;
&#xD;
          -  Inability or unwillingness to lie flat for 5 minutes and follow breathing commands&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulf Landmesser, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charite University, Berlin, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Klinikum im Friedrichshain</name>
      <address>
        <city>Berlin</city>
        <zip>10249</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Johannes Wesling</name>
      <address>
        <city>Minden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>September 15, 2019</last_update_submitted>
  <last_update_submitted_qc>September 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>David Manuel Leistner</investigator_full_name>
    <investigator_title>Coordinating Investigator</investigator_title>
  </responsible_party>
  <keyword>Acute Coronary Syndrome</keyword>
  <keyword>STE-ACS</keyword>
  <keyword>NSTE-ACS</keyword>
  <keyword>Magmaris</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>Syndrome</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- 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/NCT03773081
org study id: 4.1
nct id: NCT03773081
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the registry is to investigate the clinical performance of the Magmaris Magnesium
      Stent in STE-ACS and NSTE-ACS patients.
The Magmaris Magnesium-Stent is indicated for improving luminal diameter and stabilize
      culprit lesions in patients with coronary artery disease (CAD) including ST-segment elevation
      (STE-) as well as Non-ST-segment elevation (NSTE-) acute coronary syndrome (ACS). Patients
      scheduled for this registry, must have one angiographic clear detectable ACS-causing culprit
      lesion with a reference diameter and a lesion length, which closely match the nominal
      Magmaris reference diameter and length.

      Primary endpoint will be the procedural angiographical success at the end of PCI, defined as
      successful Magmaris implantation at the "culprit lesion site" with less than 30% final
      stenosis (by visual estimation) and distal TIMI 3 flow. Secondary endpoints will include
      clinical and angiographic parameters as well as parameters gained through OCT-imaging.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Procedural angiographical success
time frame: At the end of PCI
description: Procedural angiographical success at the end of PCI, defined as successful Magmaris implantation at the "culprit lesion site" with less than 30% final stenosis (by visual estimation) and distal TIMI 3 flow.
measure: ST-segment resolution at the electrocardiogram (ECG)
time frame: Within 60 minutes of primary PCI
description: ST-segment resolution at ECG.
measure: Procedural clinical success within hospital stay
time frame: Until hospital discharge, an expected average of 4 days
description: No in-hospital clinically-driven target lesion revascularization.
measure: Target lesion revascularization
time frame: 6 months, 12 months and 2 years
description: Clinical driven target-lesion revascularization with the use of either PCI or CABG at 6 months, 12 months and at 2 years follow-up respectively.
measure: Device-oriented composite endpoint (DOCE)
time frame: 6 months, 12 months and 2 years
description: Device-oriented composite (DOCE) endpoint of cardiac death, target vessel-related reinfarction and ischemia-driven target-lesion revascularization at 6 months, 12 months and at 2 years follow-up respectively.
measure: Major adverse cardiovascular events (MACE)
time frame: Until hospital discharge, 6 months, 12 months and 2 years
description: Cardiac death, any TV-MI, target vessel revascularization (TVR) in-hospital or during follow-up (6 months, 12 months, 2 years).
measure: All-cause death at all time points
time frame: Until hospital discharge, 6 months, 12 months and 2 years
description: Clinical Endpoint (in-hospital and at follow-up (6 months, 12 months, 2 years).
measure: Cardiac death at all time points
time frame: Until hospital discharge, 6 months, 12 months and 2 years
description: Clinical Endpoint (in-hospital and at follow-up (6 months, 12 months, 2 years).
measure: Magmaris Thrombosis
time frame: Until hospital discharge, 6 months, 12 months and 2 years
description: Any definite/probable per ARC defintion Magmaris thrombosis (in-hospital and during follow-up (6 months, 12 months, 2 years).
measure: Any Bleeding
time frame: Until hospital discharge, 6 months, 12 months and 2 years
description: Bleedings defined according to the Bleeding Academic Research Consortium (BARC) in-hospital and at follow-up (in-hospital and at follow-up (6 months, 12 months, 2 years).
measure: Vascular cerebral events
time frame: Until hospital discharge, 6 months, 12 months and 2 years
description: Vascular events documented by neurological permanent disabilities or by diagnostic imaging (MRI or CT) in-hospital and during follow-up (6 months, 12 months, 2 years).
measure: Stable angina
time frame: 6 months, 12 months and 2 years
description: Angina as assessed by Seattle angina score (SAS) at follow-up (6 months, 12 months, 2 years).
measure: Evidence for myocardial ischemia
time frame: 12 months
description: Clinical or ECG-signs for myocardial ischemia during exercise ECG at 12-month follow-up.
measure: Percent diameter stenosis
time frame: 24 months
description: Percent diameter stenosis (%DS) at in in-segment (target lesion), in-device, proximal and distal (initial and in case of clinical-indicated re-angiography) (assessed by outcome-blinded Corelab analyses, Charite).
measure: Minimal Lumen Diameter (MLD)
time frame: 24 months
description: Minimal Lumen Diameter in-segment (target lesion), in-device, proximal and distal (initial and in case of clinical-indicated re-angiography) (assessed by outcome-blinded Corelab analyses, Charite).
measure: TIMI-flow
time frame: 24 month
description: TIMI-flow before (after mechanical recanalization) and after Magmaris Implantation (assessed by outcome-blinded Corelab analyses, Charite).
measure: ACS-causing "culprit lesion" (OCT)
time frame: 24 months
description: Mechanism of ACS (Plaque-Rupture vs. Plaque-Erosion vs. other mechanisms) and culprit-plaque-characteristics (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Max/Mean/minimal Mg-Stent diameter/area after implantation and lumen late loss (OCT)
time frame: 24 months
description: Max/Mean/minimal Mg-Stent diameter/area after implantation and (in case of any clinical indicated re-angiography) lumen late loss as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Mean/minimal lumen diameter/area/volume
time frame: 24 months
description: Mean/minimal lumen diameter/area/volume within the target lesion before and after Magmaris-Implantation, as well as (in case of any clinical indicated re-angiography) as difference Re-OCT to baseline-OCT (after Magmaris Implantation) (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Mean/minimal flow-area/volume
time frame: 24 months
description: Mean/minimal flow-area/volume as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Intraluminal defect area/volume
time frame: 24 months
description: Intraluminal defect area/volume at time point re-angiography/Re-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Modified vascular healing score
time frame: 24 months
description: Modified vascular healing score (%HS; according to Räber EuroIntervention 2016; Sabate + Joner EHJ 2016) as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Presence of both malapposed and uncovered struts
time frame: 24 months
description: Presence of both malapposed and uncovered struts (%MN) of the Mg-stent, which is an individual component of the endpoint "Healing Score" as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Presence of uncovered struts alone
time frame: 24 months
description: Presence of both uncovered struts of the Mg-stent, which is an individual component of the endpoint "Healing Score" as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Presence of malapposed struts alone
time frame: 24 months
description: Presence of both malapposed struts of the Mg-stent which is an individual component of the endpoint "Healing Score" as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Incomplete strut apposition (ISA) area/volume
time frame: 24 months
description: Incomplete strut apposition (ISA) area/volume as difference Re-OCT to baseline-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Percentage of covered struts
time frame: 24 months
description: Percentage of covered struts at Re-OCT follow-up (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Mean/maximal thickness of the struts coverage
time frame: 24 months
description: Mean/maximal thickness of the struts coverage at Re-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Neointimal hyperplasia area/volume
time frame: 24 months
description: Neointimal hyperplasia area/volume at Re-OCT (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Thickness of neointimal tissue developed over lipid rich plaque
time frame: 24 months
description: Thickness of neointimal tissue developed over lipid rich plaque at Re-OCT follow-up (assessed by outcome-blinded OCT Corelab analyses German Heart Center Munich: Prof. Dr. M. Joner).
measure: Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG determination (MCG-substudy)
time frame: 24 months
description: Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG determination (ST-T Score (Angle dynamic), ST-T-analysis (distance parameter and rato-dynamics), PLP2 Score, VMCG Score (T-begin till Tmax and RP ½ till Tmax), T-dispersion Score) for the vessel with target lesion compared to angiography at ACS. A comparison to exercise-ECG at 12 months will also be performed.
measure: Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios) of MCG Determination (MCG-substudy)
time frame: 24 months
description: Diagnostic accuracy values (sensitivity, specificity, PPV, NPV, positive and likelihood ratios)of MCG determination (ST-T Score (Angle dynamic), ST-T-analysis (distance parameter and rato-dynamics) PLP2 Score, VMCG Score (T-begin till Tmax and RP ½ till Tmax), T-dispersion Score) for characteristics of the ACS-causing "culprit lesion" compared to OCT before Magmaris-Implantation.
arm group label: Magmaris implantation
arm group type: Other
description: Subjects will undergo a PCI for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice.
intervention type: Device
intervention name: Implantation of the Magmaris scaffold
description: Subjects will undergo a PCI for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice. Maximum of one single ACS-causing de novo lesions in one separate major epicardial vessels is allowed.
arm group label: Magmaris implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ulf Landmesser, Prof. Dr.
role: Principal Investigator
affiliation: Charite University, Berlin, Germany
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: David Manuel Leistner
investigator title: Coordinating Investigator
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: ST Elevation Myocardial Infarction
mesh term: Syndrome
mesh term: Infarction