<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/NCT02973529</url>
  </required_header>
  <id_info>
    <org_study_id>1-10-72-215-14</org_study_id>
    <nct_id>NCT02973529</nct_id>
  </id_info>
  <brief_title>The Bioresorbable Implants for Scaffolding Obstructions in Randomized Bifurcations (BIFSORB) Study</brief_title>
  <acronym>BIFSORB</acronym>
  <official_title>Bioresorbable Vascular Stents for Treatment of Coronary Bifurcation Lesions Assessed by Optical Coherence Tomography - The BIFSORB Study</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>
      Coronary artery disease is often treated by implantation of permanent metallic&#xD;
      stents.Coronary stents are required in the early healing phase after balloon dilatation but&#xD;
      constitute a lifelong foreign body. New bioresorbable stents have been developed and are&#xD;
      believed to improve long-term safety. The purpose of this study is to compare the safety and&#xD;
      vessel healing after treatment of simple bifurcation lesions with the CE-marked bioresorbable&#xD;
      stents Absorb and Desolve.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BIFSORB is a prospective, randomized multicenter trial comparing 6-month healing outcome&#xD;
      after treatment of simple coronary bifurcation lesions by Absorb or Desolve BRS. for&#xD;
      treatment of coronary bifurcation lesions.&#xD;
&#xD;
      BRS are promising in treatment of coronary artery disease. The concept of bifurcation&#xD;
      treatment using BRS is particular appealing as struts covering the side branch ostium may&#xD;
      resorb over time.&#xD;
&#xD;
      The aim of this study is to compare the 6 months safety and vessel healing after treatment of&#xD;
      coronary bifurcation lesions by the Desolve or Absorb BRS.&#xD;
&#xD;
      Hypothesis: Treatment of coronary bifurcation lesions using Absorb and Desolve bioresorbable&#xD;
      stents is safe. Treatment of coronary bifurcation lesions by Desolve BRS is associated with a&#xD;
      lower index of adverse vessel wall features (main vessel area stenosis, acquired&#xD;
      malapposition, evaginations, late recoil, single end attached protruding struts, side branch&#xD;
      ostial area stenosis) at 6 months compared to treatment with Absorb BRS.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Prospective, open label, single blind, randomized, feasibility and safety pilot study with&#xD;
      inclusion of 120 patients. Randomization 1:1 to Absorb or Desolve. Planned 6- and 24-month&#xD;
      follow-up by OCT and follow-up for clinical endpoints until 10 years.&#xD;
&#xD;
      Eligible patients with a bifurcation lesion are treated by the provisional technique with&#xD;
      mandatory jailing of the side branch and provisional opening of side branch ostium by the&#xD;
      mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal&#xD;
      post-dilatation is mandatory. No dilatation beyond the expansion limits of the BRS.&#xD;
&#xD;
      The patients are assessed by optical coherence tomography (OCT) before, during and after&#xD;
      implantation of the Absorb or Desolve BRS at baseline procedure and again at 6- and 24-month&#xD;
      follow-up, or before if they are readmitted with a possible target lesion failure.&#xD;
&#xD;
      The operator is not blinded to pre-PCI OCT images that may be used for sizing and positioning&#xD;
      of the scaffolds. Procedural OCT may be used to optimize scaffold implantation before&#xD;
      performing final OCT.&#xD;
&#xD;
      Results are reported as clinical safety at 6 months (myocardial infarction,&#xD;
      revascularization, death) and stent healing index by OCT including malapposition, stent&#xD;
      coverage, side branch ostial area late loss, fracture and evaginations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">September 2028</completion_date>
  <primary_completion_date type="Anticipated">November 2026</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Index of adverse vessel wall features</measure>
    <time_frame>6 months</time_frame>
    <description>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>6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: persistent malapposition</measure>
    <time_frame>6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Coverage of jailing struts</measure>
    <time_frame>6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Extra stent lumen (including evaginations)</measure>
    <time_frame>Baseline, 6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Late stent recoil</measure>
    <time_frame>6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: stent fracture</measure>
    <time_frame>Baseline, 6 and 24 months</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, 6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Ostial strut loss</measure>
    <time_frame>Baseline, 6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Mean neointimal thickness</measure>
    <time_frame>6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Stent strut coverage</measure>
    <time_frame>6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Minimal luminal area in segmental analysis</measure>
    <time_frame>Baseline, 6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Minimal stent area in segmental analysis</measure>
    <time_frame>Baseline, 6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Minimum scaffold expansion area %</measure>
    <time_frame>Baseline, 6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Segmental area stenosis</measure>
    <time_frame>Baseline, 6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Healing above calcified plaque</measure>
    <time_frame>6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optical coherence tomography endpoint: Healing above lipid plaque</measure>
    <time_frame>6 and 24 months</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>6 and 24 months</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>6 and 24 months</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, 6 and 24 months</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>6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Ostial distal main vessel area stenosis</measure>
    <time_frame>Baseline, 6 and 24 months</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>6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Proximal main vessel area stenosis</measure>
    <time_frame>Baseline, 6 and 24 months</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>6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: Minimal luminal area of all segments</measure>
    <time_frame>Baseline, 6 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural endpoints: Procedure time</measure>
    <time_frame>Baseline</time_frame>
    <description>From sheath insertion to closure device excluding treatment of other vessels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural endpoints: Contrast use</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural endpoints: Fluoroscopy time</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical endpoints: Myocardial infarction</measure>
    <time_frame>10 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical endpoints: Target lesion failure</measure>
    <time_frame>10 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical endpoints: Target lesion revascularization</measure>
    <time_frame>10 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical endpoints: Stent thrombosis</measure>
    <time_frame>10 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical endpoints: Cardiac death</measure>
    <time_frame>10 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical endpoints: Non-Cardiac death</measure>
    <time_frame>10 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Absorb</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomization to implantation of Absorb BVS in bifurcation lesion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Desolve</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomization to implantation of Desolve BRS in bifurcation lesion</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Absorb</intervention_name>
    <description>Randomization to implantation of Absorb BVS in bifurcation lesion</description>
    <arm_group_label>Absorb</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Desolve</intervention_name>
    <description>Randomization to implantation of Desolve BRS in bifurcation lesion</description>
    <arm_group_label>Desolve</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stable angina pectoris&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Stabilized non-ST elevation myocardial infarction&#xD;
&#xD;
          -  Silent angina&#xD;
&#xD;
          -  De novo coronary bifurcation lesions at LAD/diagonal, CX/obtuse marginal,&#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;
          -  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&#xD;
&#xD;
          -  Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine, everolimus&#xD;
             or novolimus&#xD;
&#xD;
          -  Unable to cover main vessel lesion with one scaffold&#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>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zealand University Hospital, Roskilde</name>
      <address>
        <city>Roskilde</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Latvian Heart Center</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Latvia</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</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/NCT02973529
org study id: 1-10-72-215-14
nct id: NCT02973529
lead sponsor: 
has dmc: Yes
Coronary artery disease is often treated by implantation of permanent metallic
      stents.Coronary stents are required in the early healing phase after balloon dilatation but
      constitute a lifelong foreign body. New bioresorbable stents have been developed and are
      believed to improve long-term safety. The purpose of this study is to compare the safety and
      vessel healing after treatment of simple bifurcation lesions with the CE-marked bioresorbable
      stents Absorb and Desolve.
BIFSORB is a prospective, randomized multicenter trial comparing 6-month healing outcome
      after treatment of simple coronary bifurcation lesions by Absorb or Desolve BRS. for
      treatment of coronary bifurcation lesions.

      BRS 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 compare the 6 months safety and vessel healing after treatment of
      coronary bifurcation lesions by the Desolve or Absorb BRS.

      Hypothesis: Treatment of coronary bifurcation lesions using Absorb and Desolve bioresorbable
      stents is safe. Treatment of coronary bifurcation lesions by Desolve BRS is associated with a
      lower index of adverse vessel wall features (main vessel area stenosis, acquired
      malapposition, evaginations, late recoil, single end attached protruding struts, side branch
      ostial area stenosis) at 6 months compared to treatment with Absorb BRS.

      Methods:

      Prospective, open label, single blind, randomized, feasibility and safety pilot study with
      inclusion of 120 patients. Randomization 1:1 to Absorb or Desolve. Planned 6- and 24-month
      follow-up by OCT and follow-up for clinical endpoints until 10 years.

      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 BRS.

      The patients are assessed by optical coherence tomography (OCT) before, during and after
      implantation of the Absorb or Desolve BRS at baseline procedure and again at 6- and 24-month
      follow-up, or before if they are readmitted with a possible target lesion failure.

      The operator is not blinded to pre-PCI OCT images that may be used for sizing and positioning
      of the scaffolds. Procedural OCT may be used to optimize scaffold implantation before
      performing final OCT.

      Results are reported as clinical safety at 6 months (myocardial infarction,
      revascularization, death) and stent healing index by OCT including malapposition, stent
      coverage, side branch ostial area late loss, fracture and evaginations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
time frame: 6 months
description: Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
measure: Index of adverse vessel wall features
time frame: 6 months
description: 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: 6 and 24 months
measure: Optical coherence tomography endpoint: persistent malapposition
time frame: 6 and 24 months
measure: Optical coherence tomography endpoint: Coverage of jailing struts
time frame: 6 and 24 months
measure: Optical coherence tomography endpoint: Extra stent lumen (including evaginations)
time frame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Late stent recoil
time frame: 6 and 24 months
measure: Optical coherence tomography endpoint: stent fracture
time frame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts
time frame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Ostial strut loss
time frame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Mean neointimal thickness
time frame: 6 and 24 months
measure: Optical coherence tomography endpoint: Stent strut coverage
time frame: 6 and 24 months
measure: Optical coherence tomography endpoint: Minimal luminal area in segmental analysis
time frame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Minimal stent area in segmental analysis
time frame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Minimum scaffold expansion area %
time frame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Segmental area stenosis
time frame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Healing above calcified plaque
time frame: 6 and 24 months
measure: Optical coherence tomography endpoint: Healing above lipid plaque
time frame: 6 and 24 months
measure: Optical coherence tomography endpoint: Acute thrombus on struts
time frame: Baseline
measure: Optical coherence tomography endpoint: Late thrombus on struts
time frame: 6 and 24 months
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: 6 and 24 months
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, 6 and 24 months
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: 6 and 24 months
measure: Angiographic endpoint: Ostial distal main vessel area stenosis
time frame: Baseline, 6 and 24 months
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: 6 and 24 months
measure: Angiographic endpoint: Proximal main vessel area stenosis
time frame: Baseline, 6 and 24 months
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: 6 and 24 months
measure: Angiographic endpoint: Minimal luminal area of all segments
time frame: Baseline, 6 and 24 months
measure: Procedural endpoints: Procedure time
time frame: Baseline
description: From sheath insertion to closure device excluding treatment of other vessels
measure: Procedural endpoints: Contrast use
time frame: Baseline
measure: Procedural endpoints: Fluoroscopy time
time frame: Baseline
measure: Clinical endpoints: Myocardial infarction
time frame: 10 years
measure: Clinical endpoints: Target lesion failure
time frame: 10 years
measure: Clinical endpoints: Target lesion revascularization
time frame: 10 years
measure: Clinical endpoints: Stent thrombosis
time frame: 10 years
measure: Clinical endpoints: Cardiac death
time frame: 10 years
measure: Clinical endpoints: Non-Cardiac death
time frame: 10 years
arm group label: Absorb
arm group type: Experimental
description: Randomization to implantation of Absorb BVS in bifurcation lesion
arm group label: Desolve
arm group type: Experimental
description: Randomization to implantation of Desolve BRS in bifurcation lesion
intervention type: Device
intervention name: Absorb
description: Randomization to implantation of Absorb BVS in bifurcation lesion
arm group label: Absorb
intervention type: Device
intervention name: Desolve
description: Randomization to implantation of Desolve BRS in bifurcation lesion
arm group label: Desolve
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: 
facility: 
facility: 
facility: 
country: Denmark
country: Latvia
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