<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/NCT01701596</url>
  </required_header>
  <id_info>
    <org_study_id>RAISE</org_study_id>
    <nct_id>NCT01701596</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Rotational Atherectomy (RA) in Coronary Dissection</brief_title>
  <official_title>Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Lesion Complicated by Coronary Dissection (RAISE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in&#xD;
      nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary&#xD;
      intervention (PCI) procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary artery dissection is a contraindication for the use of rotational atherectomy, since&#xD;
      rotational atherectomy may propagate coronary dissection. In the presence of coronary&#xD;
      dissection, conservative management is suggested for approximately 4 weeks to permit the&#xD;
      dissection to heal prior to treatment with rotational atherectomy. However, a lot of patients&#xD;
      have frequent angina attacks and some patients develop serious complications including abrupt&#xD;
      vessel closure during this period. Thus, immediate strategies cope with coronary dissection&#xD;
      induced by balloon dilation is needed for the early recovery of those patients. The present&#xD;
      study was performed to compare the safety and efficacy of immediate RA and delayed RA in the&#xD;
      treatment with nondilatable calcified lesion complicated by coronary dissection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2004</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</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>All cause death</measure>
    <time_frame>4 years</time_frame>
    <description>cardiac death and non-cardiac death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Left ventricular ejection fraction (LVEF)</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-min walk distance (6MWD)</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>angina class</measure>
    <time_frame>4 years</time_frame>
    <description>angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-fatal myocardial infarction</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac tamponade</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association (NYHA) class IV heart failure</measure>
    <time_frame>4 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Rotational atherectomy (RA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed rotational atherectomy (RA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Immediate rotational atherectomy (RA)</intervention_name>
    <description>Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.</description>
    <arm_group_label>Rotational atherectomy (RA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Delayed rotational atherectomy (RA)</intervention_name>
    <description>Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection</description>
    <arm_group_label>Delayed rotational atherectomy (RA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 30 and 85 years old&#xD;
&#xD;
          -  nondilatable calcified lesion complicated by coronary dissection during percutaneous&#xD;
             coronary intervention (PCI) procedure&#xD;
&#xD;
          -  Coronary artery dissection type A, B and type C according to the National Heart, Lung&#xD;
             and Blood Institute (NHLBI) coronary dissection criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute myocardial infarction&#xD;
&#xD;
          -  unprotected left main stenosis&#xD;
&#xD;
          -  chronic total occlusion&#xD;
&#xD;
          -  saphenous vein graft lesion&#xD;
&#xD;
          -  cardiomyopathy&#xD;
&#xD;
          -  severe valvular heart disease&#xD;
&#xD;
          -  NYHA functional class IV heart failure at baseline&#xD;
&#xD;
          -  chronic renal failure on hemodialysis&#xD;
&#xD;
          -  severe lung and liver disease or cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chengxiang Li, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiolody, Xijing Hospital, Fourth Military Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xijing Hospital, Fourth Military Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rotational atherectomy</keyword>
  <keyword>Coronary dissection</keyword>
  <keyword>Percutaneous coronary intervention</keyword>
  <keyword>Calcification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery 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/NCT01701596
org study id: RAISE
nct id: NCT01701596
lead sponsor: 
has dmc: Yes
This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in
      nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary
      intervention (PCI) procedure.
Coronary artery dissection is a contraindication for the use of rotational atherectomy, since
      rotational atherectomy may propagate coronary dissection. In the presence of coronary
      dissection, conservative management is suggested for approximately 4 weeks to permit the
      dissection to heal prior to treatment with rotational atherectomy. However, a lot of patients
      have frequent angina attacks and some patients develop serious complications including abrupt
      vessel closure during this period. Thus, immediate strategies cope with coronary dissection
      induced by balloon dilation is needed for the early recovery of those patients. The present
      study was performed to compare the safety and efficacy of immediate RA and delayed RA in the
      treatment with nondilatable calcified lesion complicated by coronary dissection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All cause death
time frame: 4 years
description: cardiac death and non-cardiac death
measure: Left ventricular ejection fraction (LVEF)
time frame: 4 years
measure: 6-min walk distance (6MWD)
time frame: 4 years
measure: angina class
time frame: 4 years
description: angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire
measure: Non-fatal myocardial infarction
time frame: 4 years
measure: Stent thrombosis
time frame: 4 years
measure: Cardiac tamponade
time frame: 4 years
measure: Stroke
time frame: 4 years
measure: Target lesion revascularization
time frame: 4 years
measure: New York Heart Association (NYHA) class IV heart failure
time frame: 4 years
arm group label: Rotational atherectomy (RA)
arm group type: Experimental
description: Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection
arm group label: Delayed rotational atherectomy (RA)
arm group type: Active Comparator
description: Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection
intervention type: Procedure
intervention name: Immediate rotational atherectomy (RA)
description: Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.
arm group label: Rotational atherectomy (RA)
intervention type: Procedure
intervention name: Delayed rotational atherectomy (RA)
description: Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection
arm group label: Delayed rotational atherectomy (RA)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Chengxiang Li, M.D., Ph.D.
role: Principal Investigator
affiliation: Department of Cardiolody, Xijing Hospital, Fourth Military Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease