<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/NCT03040934</url>
  </required_header>
  <id_info>
    <org_study_id>TARGET CTO</org_study_id>
    <nct_id>NCT03040934</nct_id>
  </id_info>
  <brief_title>Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s)</brief_title>
  <official_title>A Prospective, Open Label, Multi-center Trial of Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s) by Optical Coherent Tomography (OCT) and Coronary Angiography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai MicroPort Medical (Group) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai MicroPort Medical (Group) Co., Ltd.</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 study is a prospective, multi-center, open-label, randomized controlled clinical&#xD;
      trial,aims to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting&#xD;
      coronary stent system with abluminal grooves containing a biodegradable polymer (Firehawk™)&#xD;
      comparing the XIENCE everolimus-eluting coronary stent system in the treatment of subjects&#xD;
      with total coronary occlusion lesion(s).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will recruit 196 subjects with total coronary occlusion lesion(s) in coronary&#xD;
      arteries ≥2.25 mm to ≤4.0 mm in diameter and ≤100 mm in length (by visual estimate) in no&#xD;
      more than 10 research centers in China. All participants met the inclusion criteria will be&#xD;
      1:1 randomized to receive Firehawk™ sirolimus target-eluting coronary stent or XIENCE&#xD;
      everolimus-eluting coronary stent.&#xD;
&#xD;
      Optical Coherent Tomography (OCT) sub study: the first 44 consecutive subjects who consented&#xD;
      to participate in the OCT sub study will undergo OCT assessment at 3 months and 12 months&#xD;
      post index procedure. The OCT sub study will be performed in 3-5 pre-selected sites. The&#xD;
      clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months,and 2-5&#xD;
      years post-index procedure.The primary endpoint is in-stent late lumen loss at 12 months&#xD;
      post-index procedure.The secondary endpoint is neo-intimal thickness by Optical Coherent&#xD;
      Tomography (OCT) at 3 months post-index procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 10, 2017</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Actual">September 16, 2019</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>In-stent late lumen loss</measure>
    <time_frame>At 12 months post-index procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neo-intimal thickness by Optical Coherence Tomography (OCT)</measure>
    <time_frame>At 3 months post-index procedure</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Target Vessel Failure (TVF)</measure>
    <time_frame>During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Target Lesion Failure (TLF)</measure>
    <time_frame>During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Target Vessel Revascularization (TVR)</measure>
    <time_frame>During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Target Lesion Revascularization (TLR)</measure>
    <time_frame>During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI)</measure>
    <time_frame>During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Death (All cause, Cardiac, Non-cardiac)</measure>
    <time_frame>During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac Death/ All Myocardial Infarction</measure>
    <time_frame>During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Stent Thrombosis (per ARC definition)</measure>
    <time_frame>During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>In-stent and in-segment percent diameter stenosis (DS%)</measure>
    <time_frame>At 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>In-segment late lumen loss</measure>
    <time_frame>At 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>In-stent and in-segment minimum lumen diameter (MLD)</measure>
    <time_frame>At 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>In-stent and in-segment binary restenosis rate (%)</measure>
    <time_frame>At 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mean/Minimal Stent area (mm2)</measure>
    <time_frame>At 3 months and 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mean/Minimal Lumen area (mm2)</measure>
    <time_frame>At 3 months and 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Lumen volume (mm3)</measure>
    <time_frame>At 3 months and 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Stent volume (mm3)</measure>
    <time_frame>At 3 months and 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mean neointimal hyperplasia area (mm2)</measure>
    <time_frame>At 3 months and 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>In-stent neointimal hyperplasia volume obstruction (%)</measure>
    <time_frame>At 3 months and 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Uncovered strut rate (%)</measure>
    <time_frame>At 3 months and 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Malapposed strut rate (%)</measure>
    <time_frame>At 3 months and 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Malposed and uncovered strut rate (%)</measure>
    <time_frame>At 3 months and 12 months post-index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Technical success rate</measure>
    <time_frame>Instantly after index procedure.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Clinical procedural success rate</measure>
    <time_frame>At time of procedure up to 7 days in hospital.</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">196</enrollment>
  <condition>Drug-Eluting Stents</condition>
  <condition>Percutaneous Coronary Intervention</condition>
  <condition>Tomography, Optical Coherence</condition>
  <arm_group>
    <arm_group_label>Firehawk implantation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>98 subjects will be enrolled to receive a test device (Firehawk™).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XIENCE implantation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>98 subjects will be enrolled to receive a control device (XIENCE).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Firehawk sirolimus target eluting coronary stent system</intervention_name>
    <description>98 subjects will be enrolled to receive a test device of Firehawk sirolimus target eluting coronary stent system</description>
    <arm_group_label>Firehawk implantation</arm_group_label>
    <other_name>Firehawk™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XIENCE Everolimus-Eluting Coronary Stent System</intervention_name>
    <description>98 subjects will be enrolled to receive a control device of XIENCE Everolimus-Eluting Coronary Stent System</description>
    <arm_group_label>XIENCE implantation</arm_group_label>
    <other_name>XIENCE EES</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Clinical Inclusion Criteria:&#xD;
&#xD;
          -  CI1. Subject must be at least 18 years of age;&#xD;
&#xD;
          -  CI2. Subject (or legal guardian) understands the trial requirements and the treatment&#xD;
             procedures and provides written informed consent before any trial-specific tests or&#xD;
             procedures are performed;&#xD;
&#xD;
          -  CI3. Subject is eligible for percutaneous coronary intervention (PCI);&#xD;
&#xD;
          -  CI4. Subject has symptomatic coronary artery disease with objective evidence of&#xD;
             ischemia or silent ischemia;&#xD;
&#xD;
          -  CI5. Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);&#xD;
&#xD;
          -  CI6. Left ventricular ejection fraction (LVEF) within 60 days ≥ 35%; Exclusion&#xD;
             Criteria;&#xD;
&#xD;
          -  CI7. Subject is willing to comply with all protocol-required follow-up evaluation.&#xD;
&#xD;
        Angiographic Inclusion Criteria (visual estimate):&#xD;
&#xD;
          -  AI1. Target lesions must be new and have a visually estimated reference diameter ≥2.25&#xD;
             mm and ≤4.0 mm in autologous coronary artery;&#xD;
&#xD;
          -  AI2. Target lesions must be &lt; 100 mm in length (visual estimate) and the number of&#xD;
             implanted stents is less than 4;&#xD;
&#xD;
          -  AI3. Target lesions must be visually complete occlusion and longer than 4 weeks;&#xD;
&#xD;
          -  AI4. Target lesions must be able to pass and be successfully expanded;&#xD;
&#xD;
        Clinical Exclusion Criteria:&#xD;
&#xD;
          -  CE1. Subjects recently suffer from MI (within 1 week), and ECG changes/clinical&#xD;
             symptoms consistent with AMI or accompanied with increased cardiac biomarkers (CK-MB,&#xD;
             CK, TNT or TNI) are excluded;&#xD;
&#xD;
          -  CE2. Subjects had an organ transplant or are waiting for an organ transplant;&#xD;
&#xD;
          -  CE3. Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days&#xD;
             after PCI;&#xD;
&#xD;
          -  CE4. Subjects are undergoing chronic (over 72 hours) anticoagulant therapy (such as&#xD;
             heparin and coumarin) other than acute coronary syndrome;&#xD;
&#xD;
          -  CE5. Subjects with abnormal counts of platelet and white blood cell (WBC): platelet&#xD;
             counts less than 100×10E9/L or greater than 700×10E9/L, white blood cells less than&#xD;
             3×10E9/L;&#xD;
&#xD;
          -  CE6. Subjects have confirmed or suspected liver disease, including hepatitis lab&#xD;
             results;&#xD;
&#xD;
          -  CE7. Subjects with elevated serum creatinine level &gt;3.0mg/dL or undergoing dialysis&#xD;
             therapy;&#xD;
&#xD;
          -  CE8. Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other&#xD;
             bleeding diathesis or coagulopathy, or refused a blood transfusion;&#xD;
&#xD;
          -  CE9. Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA)&#xD;
             in the past 6 months, or with permanent nerve defects;&#xD;
&#xD;
          -  CE10. Subjects had any PCI (such as balloon angioplasty, stent, cutting&#xD;
             balloon,atherectomy) treatment in target vessels (including collateral) within 12&#xD;
             months prior to baseline;&#xD;
&#xD;
          -  CE11. Subjects plan to undergo PCI or CABG after the baseline PCI;&#xD;
&#xD;
          -  CE12. Subjects have any coronary endovascular brachytherapy treatment previously;&#xD;
&#xD;
          -  CE13. Subjects associated with drugs allergy (such as sirolimus, or structure-related&#xD;
             compounds fluorinated polymers, thiophenepyridine or aspirin);&#xD;
&#xD;
          -  CE14. Subjects are suffering from other serious illness (such as cancer, congestive&#xD;
             heart failure), which may cause drop in life expectancy to less than 18 months;&#xD;
&#xD;
          -  CE15. Subjects are currently abusing drugs (such as alcohol, cocaine, heroin, etc);&#xD;
&#xD;
          -  CE16. Subject plan to undergo any operations that may lead to confuse with the&#xD;
             programme;&#xD;
&#xD;
          -  CE17. Subjects were participating in another study of drug or medical device which did&#xD;
             not meet its primary endpoint;&#xD;
&#xD;
          -  CE18. Subjects plan to pregnant within 18 months after baseline;&#xD;
&#xD;
          -  CE19. Subjects are pregnant or breastfeeding women.&#xD;
&#xD;
        Angiographic Exclusion Criteria (visual estimate):&#xD;
&#xD;
          -  AE1. Target lesions with the following criteria: left main, saphenous vein grafts or&#xD;
             arterial grafts, via saphenous vein grafts or arterial graft, and in-stent stenosis;&#xD;
&#xD;
          -  AE2. Subjects with unprotected left main coronary artery disease (diameter stenosis&#xD;
             &gt;50%);&#xD;
&#xD;
          -  AE3. Subjects have a protected left main coronary artery disease (diameter stenosis&gt;&#xD;
             50% and left coronary artery bypass surgery), as well as target lesions located in the&#xD;
             LAD and LCX;&#xD;
&#xD;
          -  AE4. Subjects with other lesions of clinical significance, may be need intervention&#xD;
             within 18 months after baseline.&#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>Yaling Han, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The General Hospital of Shenyang Military</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The General Hospital of Shenyang Military</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</mesh_term>
    <mesh_term>Everolimus</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Additionally, study protocol will be available. The data will become available for the beginning 3 months and ending 5 years following article publication. The access criteria are as follow:&#xD;
(With) Researchers who provide a methodologically sound proposal. (For the analysis) to achieve aims in the approved proposal. (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).&#xD;
If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Beginning 3 months and ending 5 years following article publication</ipd_time_frame>
    <ipd_access_criteria>(With) Researchers who provide a methodologically sound proposal. (For the analysis) to achieve aims in the approved proposal. (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).</ipd_access_criteria>
  </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/NCT03040934
org study id: TARGET CTO
nct id: NCT03040934
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, multi-center, open-label, randomized controlled clinical
      trial,aims to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting
      coronary stent system with abluminal grooves containing a biodegradable polymer (Firehawk™)
      comparing the XIENCE everolimus-eluting coronary stent system in the treatment of subjects
      with total coronary occlusion lesion(s).
This study will recruit 196 subjects with total coronary occlusion lesion(s) in coronary
      arteries ≥2.25 mm to ≤4.0 mm in diameter and ≤100 mm in length (by visual estimate) in no
      more than 10 research centers in China. All participants met the inclusion criteria will be
      1:1 randomized to receive Firehawk™ sirolimus target-eluting coronary stent or XIENCE
      everolimus-eluting coronary stent.

      Optical Coherent Tomography (OCT) sub study: the first 44 consecutive subjects who consented
      to participate in the OCT sub study will undergo OCT assessment at 3 months and 12 months
      post index procedure. The OCT sub study will be performed in 3-5 pre-selected sites. The
      clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months,and 2-5
      years post-index procedure.The primary endpoint is in-stent late lumen loss at 12 months
      post-index procedure.The secondary endpoint is neo-intimal thickness by Optical Coherent
      Tomography (OCT) at 3 months post-index procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: In-stent late lumen loss
time frame: At 12 months post-index procedure
measure: Neo-intimal thickness by Optical Coherence Tomography (OCT)
time frame: At 3 months post-index procedure
measure: Target Vessel Failure (TVF)
time frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
measure: Target Lesion Failure (TLF)
time frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
measure: Target Vessel Revascularization (TVR)
time frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
measure: Target Lesion Revascularization (TLR)
time frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
measure: Myocardial Infarction (MI,including Q-wave MI and non Q-wave MI)
time frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
measure: Death (All cause, Cardiac, Non-cardiac)
time frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
measure: Cardiac Death/ All Myocardial Infarction
time frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
measure: Stent Thrombosis (per ARC definition)
time frame: During hospitalization and 30 days, 3 months, 6 months, 12 months and 2-5 years post-index procedure.
measure: In-stent and in-segment percent diameter stenosis (DS%)
time frame: At 12 months post-index procedure.
measure: In-segment late lumen loss
time frame: At 12 months post-index procedure.
measure: In-stent and in-segment minimum lumen diameter (MLD)
time frame: At 12 months post-index procedure.
measure: In-stent and in-segment binary restenosis rate (%)
time frame: At 12 months post-index procedure.
measure: Mean/Minimal Stent area (mm2)
time frame: At 3 months and 12 months post-index procedure.
measure: Mean/Minimal Lumen area (mm2)
time frame: At 3 months and 12 months post-index procedure.
measure: Lumen volume (mm3)
time frame: At 3 months and 12 months post-index procedure.
measure: Stent volume (mm3)
time frame: At 3 months and 12 months post-index procedure.
measure: Mean neointimal hyperplasia area (mm2)
time frame: At 3 months and 12 months post-index procedure.
measure: In-stent neointimal hyperplasia volume obstruction (%)
time frame: At 3 months and 12 months post-index procedure.
measure: Uncovered strut rate (%)
time frame: At 3 months and 12 months post-index procedure.
measure: Malapposed strut rate (%)
time frame: At 3 months and 12 months post-index procedure.
measure: Malposed and uncovered strut rate (%)
time frame: At 3 months and 12 months post-index procedure.
measure: Technical success rate
time frame: Instantly after index procedure.
measure: Clinical procedural success rate
time frame: At time of procedure up to 7 days in hospital.
arm group label: Firehawk implantation
arm group type: Active Comparator
description: 98 subjects will be enrolled to receive a test device (Firehawk™).
arm group label: XIENCE implantation
arm group type: Active Comparator
description: 98 subjects will be enrolled to receive a control device (XIENCE).
intervention type: Device
intervention name: Firehawk sirolimus target eluting coronary stent system
description: 98 subjects will be enrolled to receive a test device of Firehawk sirolimus target eluting coronary stent system
arm group label: Firehawk implantation
other name: Firehawk™
intervention type: Device
intervention name: XIENCE Everolimus-Eluting Coronary Stent System
description: 98 subjects will be enrolled to receive a control device of XIENCE Everolimus-Eluting Coronary Stent System
arm group label: XIENCE implantation
other name: XIENCE EES
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yaling Han, MD
role: Principal Investigator
affiliation: The General Hospital of Shenyang Military
facility: 
country: China
responsible party type: Sponsor
mesh term: Sirolimus
mesh term: Everolimus
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Additionally, study protocol will be available. The data will become available for the beginning 3 months and ending 5 years following article publication. The access criteria are as follow:
(With) Researchers who provide a methodologically sound proposal. (For the analysis) to achieve aims in the approved proposal. (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).
If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.
ipd info type: Study Protocol
ipd time frame: Beginning 3 months and ending 5 years following article publication
ipd access criteria: (With) Researchers who provide a methodologically sound proposal. (For the analysis) to achieve aims in the approved proposal. (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).