<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/NCT03806621</url>
  </required_header>
  <id_info>
    <org_study_id>2017033</org_study_id>
    <nct_id>NCT03806621</nct_id>
  </id_info>
  <brief_title>Rota China Registry</brief_title>
  <official_title>A Post-Approval Study of the RotablatorTM Rotational Atherectomy System in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BSC International Medical Trading (Shanghai) Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Anzhen Hospital</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>
      Rotational atherectomy (RA) facilitates percutaneous coronary intervention for complex de&#xD;
      novo lesions with severe calcification. Some observational studies and a small randomized&#xD;
      trial indicated that a strategy of routine RA did not conferred reduction in restenosis or&#xD;
      MACE, but these studies are limited by missing follow-up, insufficient power to compare&#xD;
      outcomes, and confounding factors in the RA group (long lesion length, etc.). With recent&#xD;
      developments in medical therapy, advances in design and delivery of drug-eluting stents&#xD;
      (DES), and advances in noninvasive and intravascular coronary imaging, the use of RA in&#xD;
      current real-world practice remains to be well determined. We aimed to compile real-world&#xD;
      clinical outcomes data for the RotablatorTM Rotational Atherectomy System in routine clinical&#xD;
      practice in China.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2018</start_date>
  <completion_date type="Actual">January 20, 2022</completion_date>
  <primary_completion_date type="Actual">December 27, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Major adverse cardiovascular event (MACE) (primary safety endpoint)</measure>
    <time_frame>30 days</time_frame>
    <description>The composite of any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI), or cardiac death. Periprocedural myocardial infarction, defined as in patients with normal baseline CK-MB, the peak CK-MB measured within 48 hours of the procedure rises to ≥ 10 x the local laboratory ULN, or to ≥ 5 x ULN with new pathologic Q-waves in ≥ 2 contiguous leads or new persistent LBBB (according to SCAI definition. J Am Coll Cardiol 2013;62:1563-70)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procedural success rate (primary efficacy endpoint)</measure>
    <time_frame>Peri-procedural</time_frame>
    <description>A mean lesion diameter stenosis &lt;30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, target vessel revascularization (TVR), or cardiac death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TLR rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion failure (TLF) rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TVR rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel failure (TVF) rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MI rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-cardiac death rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death or MI rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death or MI rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death, MI, or TVR rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis (ST) rate</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subgroup analyses of MACE</measure>
    <time_frame>At 30 days and 12 months post-index procedure</time_frame>
    <description>1. Age (&lt; 65 years vs. ≥ 65 years), 2. Female, 3. Hypertension, 4. Diabetes, 5. CKD, 6. Left ventricular ejection fraction (≤ 50% vs. &gt; 50%), 7. LM lesion, 8. Long lesion, 9. CTO, 10. Bifurcation lesion, 11. Speed of rotation, 12. Maximal burr size, 13. IVUS or OCT use</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of arterial perforation (rotational atherectomy related or non-related)</measure>
    <time_frame>Peri-procedural</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Rate of abrupt coronary occlusion (including dissection and thrombosis)</measure>
    <time_frame>Peri-procedural</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Rate of significant coronary dissection (NHLBI types C-F)</measure>
    <time_frame>Peri-procedural</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Rate of consistent no reflow</measure>
    <time_frame>Peri-procedural</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">980</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Rotational Atherectomy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rotational Atherectomy</intervention_name>
    <description>Patients with severe calcified lesions will receive rotational atherectomy during index PCI</description>
    <arm_group_label>Rotational Atherectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This national, multi-center, prospective, observational study will enroll at least 1000&#xD;
        subjects in about 18 to 20 sites in China. All subjects who are candidates for PCI, signed&#xD;
        the informed consent form and eligible to receive the treatment using RotablatorTM&#xD;
        Rotational Atherectomy System will be evaluated for enrollment in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years old&#xD;
&#xD;
          -  Subject who is clinically indicated for PCI/stenting&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Subject is willing to comply with all protocol-required follow-up evaluation&#xD;
&#xD;
          -  Subject must meet one of following angiographic/procedural inclusion criteria:&#xD;
&#xD;
               -  Target lesion is moderately to severely calcified by visual estimate&#xD;
&#xD;
               -  Unsuccessful balloon dilatation of the target lesion&#xD;
&#xD;
               -  Unsuccessful passage of device(s) (microcatheter, balloon, or stent) across the&#xD;
                  target lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with&#xD;
             acute MI within 2 weeks&#xD;
&#xD;
          -  Subject has any of the following angiographic findings:&#xD;
&#xD;
               -  Thrombus present in the target vessel (by visual estimate)&#xD;
&#xD;
               -  Significant dissection present in the target vessel (NHLBI types C-F)&#xD;
&#xD;
               -  Lesion angulation &gt; 60°(by visual estimate)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of USTC</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital, Guangdong Academy of Medical Science</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fuwai Central China Cardiovascular Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing First hospital, Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital, the Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital (Qingdao), Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Fourth Central Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First People's Hospital of Yunnan Province</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Anzhen Hospital</investigator_affiliation>
    <investigator_full_name>Shao-Ping Nie</investigator_full_name>
    <investigator_title>Professor of Medicine, Director, Center for Coronary Artery Disease, Division of Cardiology</investigator_title>
  </responsible_party>
  <keyword>coronary artery disease</keyword>
  <keyword>percutaneous coronary intervention</keyword>
  <keyword>rotational atherectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</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/NCT03806621
org study id: 2017033
nct id: NCT03806621
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Rotational atherectomy (RA) facilitates percutaneous coronary intervention for complex de
      novo lesions with severe calcification. Some observational studies and a small randomized
      trial indicated that a strategy of routine RA did not conferred reduction in restenosis or
      MACE, but these studies are limited by missing follow-up, insufficient power to compare
      outcomes, and confounding factors in the RA group (long lesion length, etc.). With recent
      developments in medical therapy, advances in design and delivery of drug-eluting stents
      (DES), and advances in noninvasive and intravascular coronary imaging, the use of RA in
      current real-world practice remains to be well determined. We aimed to compile real-world
      clinical outcomes data for the RotablatorTM Rotational Atherectomy System in routine clinical
      practice in China.
observational model: Cohort
time perspective: Prospective
measure: Major adverse cardiovascular event (MACE) (primary safety endpoint)
time frame: 30 days
description: The composite of any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI), or cardiac death. Periprocedural myocardial infarction, defined as in patients with normal baseline CK-MB, the peak CK-MB measured within 48 hours of the procedure rises to ≥ 10 x the local laboratory ULN, or to ≥ 5 x ULN with new pathologic Q-waves in ≥ 2 contiguous leads or new persistent LBBB (according to SCAI definition. J Am Coll Cardiol 2013;62:1563-70)
measure: Procedural success rate (primary efficacy endpoint)
time frame: Peri-procedural
description: A mean lesion diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, target vessel revascularization (TVR), or cardiac death
measure: TLR rate
time frame: At 30 days and 12 months post-index procedure
measure: Target lesion failure (TLF) rate
time frame: At 30 days and 12 months post-index procedure
measure: TVR rate
time frame: At 30 days and 12 months post-index procedure
measure: Target vessel failure (TVF) rate
time frame: At 30 days and 12 months post-index procedure
measure: MI rate
time frame: At 30 days and 12 months post-index procedure
measure: Cardiac death rate
time frame: At 30 days and 12 months post-index procedure
measure: Non-cardiac death rate
time frame: At 30 days and 12 months post-index procedure
measure: All-cause death rate
time frame: At 30 days and 12 months post-index procedure
measure: Cardiac death or MI rate
time frame: At 30 days and 12 months post-index procedure
measure: All-cause death or MI rate
time frame: At 30 days and 12 months post-index procedure
measure: All-cause death, MI, or TVR rate
time frame: At 30 days and 12 months post-index procedure
measure: Stent thrombosis (ST) rate
time frame: At 30 days and 12 months post-index procedure
measure: Subgroup analyses of MACE
time frame: At 30 days and 12 months post-index procedure
description: 1. Age (< 65 years vs. ≥ 65 years), 2. Female, 3. Hypertension, 4. Diabetes, 5. CKD, 6. Left ventricular ejection fraction (≤ 50% vs. > 50%), 7. LM lesion, 8. Long lesion, 9. CTO, 10. Bifurcation lesion, 11. Speed of rotation, 12. Maximal burr size, 13. IVUS or OCT use
measure: Rate of arterial perforation (rotational atherectomy related or non-related)
time frame: Peri-procedural
measure: Rate of abrupt coronary occlusion (including dissection and thrombosis)
time frame: Peri-procedural
measure: Rate of significant coronary dissection (NHLBI types C-F)
time frame: Peri-procedural
measure: Rate of consistent no reflow
time frame: Peri-procedural
arm group label: Rotational Atherectomy
intervention type: Procedure
intervention name: Rotational Atherectomy
description: Patients with severe calcified lesions will receive rotational atherectomy during index PCI
arm group label: Rotational Atherectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Anzhen Hospital
investigator full name: Shao-Ping Nie
investigator title: Professor of Medicine, Director, Center for Coronary Artery Disease, Division of Cardiology
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease