<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/NCT03027856</url>
  </required_header>
  <id_info>
    <org_study_id>1-10-72-194-16</org_study_id>
    <nct_id>NCT03027856</nct_id>
  </id_info>
  <brief_title>The BIFSORB Pilot Study II</brief_title>
  <acronym>BIFSORB P-II</acronym>
  <official_title>A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions - The BIFSORB Pilot Study II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital Skejby</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aarhus University Hospital Skejby</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS&#xD;
      for treatment of coronary bifurcation lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bioresorbable stents are promising in treatment of coronary artery disease. The concept of&#xD;
      bifurcation treatment using BRS is particular appealing as struts covering the side branch&#xD;
      ostium may resorb over time.&#xD;
&#xD;
      The aim of this study is to investigate the feasibility and safety of the Magmaris BRS for&#xD;
      treatment of coronary bifurcation lesions.&#xD;
&#xD;
      Hypothesis: treatment of coronary bifurcation lesions using the Magmaris BRS is safe and&#xD;
      feasible.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The study is a proof-of-concept, prospective, single arm study with inclusion of 20 patients.&#xD;
      Planned 1-and 12-month follow-up by optical coherence tomography (OCT) and follow-up for&#xD;
      clinical endpoints until 5 years.&#xD;
&#xD;
      Written informed consent is required before the procedure is performed. Eligible patients&#xD;
      with a bifurcation lesion are treated by the provisional technique with mandatory jailing of&#xD;
      the side branch and provisional opening of side branch ostium by the mini-kiss technique in&#xD;
      case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No&#xD;
      dilatation beyond the expansion limits of the stent.&#xD;
&#xD;
      At baseline, the target lesion is assessed by OCT before, during and after implantation of&#xD;
      the Magmaris BRS. OCT assessment is performed again at 1- and 12-month follow-up, or before&#xD;
      if the patient is readmitted with a possible target lesion failure.&#xD;
&#xD;
      The operator is not blinded to the OCT images as pre-PCI images should be used for sizing and&#xD;
      positioning of the stent, and procedural OCT images are used to optimize stent implantation&#xD;
      before performing final OCT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">August 19, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death</measure>
    <time_frame>1 month</time_frame>
    <description>Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Index of adverse vessel wall features by OCT</measure>
    <time_frame>1 month</time_frame>
    <description>Index based on: side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Acute malapposition</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Acquired malapposition</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Persistent malapposition</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Coverage of jailing struts</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Extra stent lumen (including evaginations)</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Late stent recoil</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Stent fracture</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Ostial strut loss</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Mean neointimal thickness</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Stent strut coverage</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Minimal luminal area in segmental analysis</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Minimal stent area in segmental analysis</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Minimum stent expansion area %</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Segmental area stenosis</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Healing above calcified plaque</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Healing above lipid plaque</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Acute thrombus on struts</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Late thrombus on struts</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Acute expansion</measure>
    <time_frame>Baseline</time_frame>
    <description>Measured in segments with: 1) calcified plaque, 2) lipid plaque, 3) area after predilatation &lt; 30% of reference area, 4) stenosed segments (&gt;50% area stenosis) with no dissections after predilatation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Late recoil</measure>
    <time_frame>1 month</time_frame>
    <description>Measured in segments with: 1) calcified plaque, 2) lipid plaque, 3) area after predilatation &lt; 30% of reference area, 4) stenosed segments (&gt;50% area stenosis) with no dissections after predilatation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Ostial side branch area stenosis</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Ostial side branch acute gain after main vessel stenting</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Ostial side branch late loss</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Ostial distal main vessel area stenosis</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Ostial distal main vessel late loss</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Proximal main vessel area stenosis</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Proximal main vessel late loss</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Minimal luminal area of all segments</measure>
    <time_frame>Baseline and 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural endpoint: Procedure time</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural endpoint: Contrast use in mL</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural endpoint: Fluoroscopy time</measure>
    <time_frame>Intraoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death</measure>
    <time_frame>6 months</time_frame>
    <description>Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death</measure>
    <time_frame>24 months</time_frame>
    <description>Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death</measure>
    <time_frame>60 months</time_frame>
    <description>Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical endpoint: myocardial infarction</measure>
    <time_frame>5 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical endpoint: target lesion failure</measure>
    <time_frame>5 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical endpoint: target lesion revascularization</measure>
    <time_frame>5 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical endpoint: stent thrombosis</measure>
    <time_frame>5 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical endpoint: cardiac death</measure>
    <time_frame>5 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical endpoint: non-cardiac death</measure>
    <time_frame>5 years</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Magmaris</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of sirolimus eluting bioresorbable magnesium stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magmaris</intervention_name>
    <description>Implantation of a sirolimus eluting bioresorbable magnesium stent</description>
    <arm_group_label>Magmaris</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable angina pectoris&#xD;
&#xD;
          -  Stabilized non-ST elevation myocardial infarction&#xD;
&#xD;
          -  Silent angina pectoris&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  De novo coronary bifurcation lesion at LAD/diagonal, CX/obtuse marginal or&#xD;
             RCA-PDA/posterolateral branch&#xD;
&#xD;
          -  All Medina classes except Medina x.x.1.&#xD;
&#xD;
          -  Diameter of side branch ≥ 2.5 mm&#xD;
&#xD;
          -  Side branch diameter stenosis less than 50%&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ST-elevation infarction within 48 hours&#xD;
&#xD;
          -  Expected survival &lt; 1 year&#xD;
&#xD;
          -  Severe heart failure (NYHA≥III)&#xD;
&#xD;
          -  S-creatinine &gt; 120 µmol/L or GFR &lt; 0.45 mL/min per 1.73 m2&#xD;
&#xD;
          -  Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine or sirolimus&#xD;
&#xD;
          -  Unable to cover main vessel lesion with one stent&#xD;
&#xD;
          -  Severe tortuosity&#xD;
&#xD;
          -  Severe calcification&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evald H Christiansen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus N</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital Skejby</investigator_affiliation>
    <investigator_full_name>Evald Hoej Christiansen</investigator_full_name>
    <investigator_title>Principal investigator (MD, PhD)</investigator_title>
  </responsible_party>
  <keyword>Percutaneous intervention (PCI)</keyword>
  <keyword>Optical coherence tomography (OCT)</keyword>
  <keyword>Bifurcation lesion</keyword>
  <keyword>Bioresorbable stents (BRS)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03027856
org study id: 1-10-72-194-16
nct id: NCT03027856
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS
      for treatment of coronary bifurcation lesions.
Bioresorbable stents are promising in treatment of coronary artery disease. The concept of
      bifurcation treatment using BRS is particular appealing as struts covering the side branch
      ostium may resorb over time.

      The aim of this study is to investigate the feasibility and safety of the Magmaris BRS for
      treatment of coronary bifurcation lesions.

      Hypothesis: treatment of coronary bifurcation lesions using the Magmaris BRS is safe and
      feasible.

      Methods:

      The study is a proof-of-concept, prospective, single arm study with inclusion of 20 patients.
      Planned 1-and 12-month follow-up by optical coherence tomography (OCT) and follow-up for
      clinical endpoints until 5 years.

      Written informed consent is required before the procedure is performed. Eligible patients
      with a bifurcation lesion are treated by the provisional technique with mandatory jailing of
      the side branch and provisional opening of side branch ostium by the mini-kiss technique in
      case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No
      dilatation beyond the expansion limits of the stent.

      At baseline, the target lesion is assessed by OCT before, during and after implantation of
      the Magmaris BRS. OCT assessment is performed again at 1- and 12-month follow-up, or before
      if the patient is readmitted with a possible target lesion failure.

      The operator is not blinded to the OCT images as pre-PCI images should be used for sizing and
      positioning of the stent, and procedural OCT images are used to optimize stent implantation
      before performing final OCT.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
time frame: 1 month
description: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
measure: Index of adverse vessel wall features by OCT
time frame: 1 month
description: Index based on: side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain
measure: Optical coherence tomography endpoint: Acute malapposition
time frame: Baseline
measure: Optical coherence tomography endpoint: Acquired malapposition
time frame: 1 month
measure: Optical coherence tomography endpoint: Persistent malapposition
time frame: 1 month
measure: Optical coherence tomography endpoint: Coverage of jailing struts
time frame: 1 month
measure: Optical coherence tomography endpoint: Extra stent lumen (including evaginations)
time frame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Late stent recoil
time frame: 1 month
measure: Optical coherence tomography endpoint: Stent fracture
time frame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts
time frame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Ostial strut loss
time frame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Mean neointimal thickness
time frame: 1 month
measure: Optical coherence tomography endpoint: Stent strut coverage
time frame: 1 month
measure: Optical coherence tomography endpoint: Minimal luminal area in segmental analysis
time frame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Minimal stent area in segmental analysis
time frame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Minimum stent expansion area %
time frame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Segmental area stenosis
time frame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Healing above calcified plaque
time frame: 1 month
measure: Optical coherence tomography endpoint: Healing above lipid plaque
time frame: 1 month
measure: Optical coherence tomography endpoint: Acute thrombus on struts
time frame: Baseline
measure: Optical coherence tomography endpoint: Late thrombus on struts
time frame: 1 month
measure: Optical coherence tomography endpoint: Acute expansion
time frame: Baseline
description: Measured in segments with: 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation
measure: Optical coherence tomography endpoint: Late recoil
time frame: 1 month
description: Measured in segments with: 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation
measure: Angiographic endpoint: Ostial side branch area stenosis
time frame: Baseline and 1 month
measure: Angiographic endpoint: Ostial side branch acute gain after main vessel stenting
time frame: Baseline
measure: Angiographic endpoint: Ostial side branch late loss
time frame: 1 month
measure: Angiographic endpoint: Ostial distal main vessel area stenosis
time frame: Baseline and 1 month
measure: Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting
time frame: Baseline
measure: Angiographic endpoint: Ostial distal main vessel late loss
time frame: 1 month
measure: Angiographic endpoint: Proximal main vessel area stenosis
time frame: Baseline and 1 month
measure: Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting
time frame: Baseline
measure: Angiographic endpoint: Proximal main vessel late loss
time frame: 1 month
measure: Angiographic endpoint: Minimal luminal area of all segments
time frame: Baseline and 1 month
measure: Procedural endpoint: Procedure time
time frame: Intraoperative
measure: Procedural endpoint: Contrast use in mL
time frame: Intraoperative
measure: Procedural endpoint: Fluoroscopy time
time frame: Intraoperative
measure: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
time frame: 6 months
description: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
measure: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
time frame: 24 months
description: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
measure: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
time frame: 60 months
description: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
measure: Clinical endpoint: myocardial infarction
time frame: 5 years
measure: Clinical endpoint: target lesion failure
time frame: 5 years
measure: Clinical endpoint: target lesion revascularization
time frame: 5 years
measure: Clinical endpoint: stent thrombosis
time frame: 5 years
measure: Clinical endpoint: cardiac death
time frame: 5 years
measure: Clinical endpoint: non-cardiac death
time frame: 5 years
arm group label: Magmaris
arm group type: Experimental
description: Implantation of sirolimus eluting bioresorbable magnesium stent
intervention type: Device
intervention name: Magmaris
description: Implantation of a sirolimus eluting bioresorbable magnesium stent
arm group label: Magmaris
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evald H Christiansen, MD, PhD
role: Principal Investigator
affiliation: Aarhus University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital Skejby
investigator full name: Evald Hoej Christiansen
investigator title: Principal investigator (MD, PhD)
mesh term: Coronary Artery Disease
sharing ipd: Undecided