<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/NCT01670318</url>
  </required_header>
  <id_info>
    <org_study_id>SPECIALIST Registry</org_study_id>
    <nct_id>NCT01670318</nct_id>
  </id_info>
  <brief_title>Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets</brief_title>
  <acronym>SPECIALIST</acronym>
  <official_title>Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The PCI Guideline Research Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The PCI Guideline Research Society</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium&#xD;
      everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the&#xD;
      identical antiproliferative agent and polymer but with a novel platinum chromium scaffold&#xD;
      designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity,&#xD;
      radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex&#xD;
      coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left&#xD;
      main trunk disease, and small vessel diseases is still unknown.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site</measure>
    <time_frame>In hospital</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel revascularization</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>24 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>24 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization</measure>
    <time_frame>24 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)</measure>
    <time_frame>24 month</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>platinum chromium everolimus-eluting stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)</intervention_name>
    <arm_group_label>platinum chromium everolimus-eluting stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A patient with ischemic heart disease including stable angina pectoris and acute&#xD;
             coronary syndrome&#xD;
&#xD;
          2. Male or non-pregnant female&#xD;
&#xD;
          3. Key lesion inclusion criteria as follows&#xD;
&#xD;
               1. Multi-vessel diseases&#xD;
&#xD;
               2. Long lesion (lesion length &gt;30mm by visual estimation)&#xD;
&#xD;
               3. Small vessel disease (reference diameter &lt;2.5mm by visual estimation)&#xD;
&#xD;
               4. Bifurcation lesion&#xD;
&#xD;
               5. Ostial lesion&#xD;
&#xD;
               6. Calcified lesion&#xD;
&#xD;
               7. Protected or non-protected left main trunk disease&#xD;
&#xD;
               8. Chronic total occlusion&#xD;
&#xD;
               9. In stent restenosis of bare metal stent or everolimus-eluting stent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine,&#xD;
             clopidogrel or X-ray contrast media.&#xD;
&#xD;
          2. Serum creatinine level &gt;3.0 mg/dL&#xD;
&#xD;
          3. Other concomitant disease or medical condition that could impact patient/procedural&#xD;
             outcomes, such as history of bleeding diathesis or cancer within 5 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuji Oikawa, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cardiovascular Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kenya Nasu, MD, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Toyohashi Heart Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kenya Nasu, MD, FACC</last_name>
    <phone>+81532373377</phone>
    <email>yuyatomoya@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yuji Oikawa, MD,PｈD</last_name>
    <phone>+81532373377</phone>
    <email>nasu@heart-center.or.jp</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aichi Medical University Hospital</name>
      <address>
        <city>Nagakute</city>
        <state>Aichi</state>
        <zip>480-1195</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hiroaki Takashima</last_name>
    </contact>
    <investigator>
      <last_name>Hiroaki Takashima, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Toyohashi Heart Center</name>
      <address>
        <city>Toyohashi</city>
        <state>Aichi</state>
        <zip>441-8530</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kenya Nasu, MD</last_name>
    </contact>
    <investigator>
      <last_name>Kenya Nasu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Juntendo University Urayasu Hospital</name>
      <address>
        <city>Urayasu</city>
        <state>Chiba</state>
        <zip>279-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ken Yokoyama</last_name>
    </contact>
    <investigator>
      <last_name>Ken Tokoyama, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kokura Memorial Hospital</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>802-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Shinichi Shirai</last_name>
    </contact>
    <investigator>
      <last_name>Shinichi Shirai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hoshi General Hospital</name>
      <address>
        <city>Koriyama</city>
        <state>Fukushima</state>
        <zip>963-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yuichi Ujiie</last_name>
    </contact>
    <investigator>
      <last_name>Yuichi Ujiie, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Southern Tohoku Research Institute for Neuroscience</name>
      <address>
        <city>Koriyama</city>
        <state>Fukushima</state>
        <zip>963-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mitsuru Muto</last_name>
    </contact>
    <investigator>
      <last_name>Muto Mitsuru, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gunma Prefectural Cardiovascular Center</name>
      <address>
        <city>Maebashi</city>
        <state>Gunma</state>
        <zip>371-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ren Kawaguchi</last_name>
    </contact>
    <investigator>
      <last_name>Ren Kawaguchi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gunma University Hospital</name>
      <address>
        <city>Maebashi</city>
        <state>Gunma</state>
        <zip>371-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ryuichi Funada</last_name>
    </contact>
    <investigator>
      <last_name>Ryuichi Funada, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ota Memorial Hospital</name>
      <address>
        <city>Ota</city>
        <state>Gunma</state>
        <zip>373-8585</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hidetoshi Anzai</last_name>
    </contact>
    <investigator>
      <last_name>Hidetoshi Anzai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Megumino Hospital</name>
      <address>
        <city>Eniwa</city>
        <state>Hokkaido</state>
        <zip>061-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Noriko Makiguchi</last_name>
    </contact>
    <investigator>
      <last_name>Noriko Makiguchi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>JA Hokkaido Engaru Kosei General Hospital</name>
      <address>
        <city>Monbetsu</city>
        <state>Hokkaido</state>
        <zip>099-0404</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Takahide Suzuki</last_name>
    </contact>
    <investigator>
      <last_name>Takahide Suzuki, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nayoro City General Hospital</name>
      <address>
        <city>Nayoro</city>
        <state>Hokkaido</state>
        <zip>096-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Masaru Yamaki</last_name>
    </contact>
    <investigator>
      <last_name>Masaru Yamaki, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sapporo Cardio Vascular Clinic</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>007-0849</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yoshifumi Kashima</last_name>
    </contact>
    <investigator>
      <last_name>Yoshifumi Kashima, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kansai Rosai Hospital</name>
      <address>
        <city>Amagasaki</city>
        <state>Hyogo</state>
        <zip>660-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Masaki Awata</last_name>
    </contact>
    <investigator>
      <last_name>Masaki Awata, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kakogawa East City Hospital</name>
      <address>
        <city>Kakogawa</city>
        <state>Hyogo</state>
        <zip>685-0115</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Makoto Kadotani</last_name>
    </contact>
    <investigator>
      <last_name>Makoto Kadotani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Toshiro Shinke</last_name>
    </contact>
    <investigator>
      <last_name>Toshiro Shinke, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tsukuba Medical Center Hospital</name>
      <address>
        <city>Tsukuba</city>
        <state>Ibaragi</state>
        <zip>305-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hidetaka Nishina</last_name>
    </contact>
    <investigator>
      <last_name>Hidetaka Nishina, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yokohama Rosai Hospital</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>222-0036</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kazuhiko Yumoto</last_name>
    </contact>
    <investigator>
      <last_name>Kazuhiko YUmoto, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yokohama City Minato Red Cross Hospital</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>231-8682</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tsukasa Shimura</last_name>
    </contact>
    <investigator>
      <last_name>Tsukasa Shimura, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Daini Okamoto General Hospital</name>
      <address>
        <city>Uji</city>
        <state>Kyoto</state>
        <zip>611-0025</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Masaki Tanabe</last_name>
    </contact>
    <investigator>
      <last_name>Masaki Tanabe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Matsumoto Kyoritsu Hospital</name>
      <address>
        <city>Matsumoto</city>
        <state>Nagano</state>
        <zip>390-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hidetoshi Abe</last_name>
    </contact>
    <investigator>
      <last_name>Hidetoshi Abe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rinku General Medical Center</name>
      <address>
        <city>Izumisano</city>
        <state>Osaka</state>
        <zip>598-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yoshihiro Takeda</last_name>
    </contact>
    <investigator>
      <last_name>Yoshihiro Takeda, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hokusetsu General Hospital</name>
      <address>
        <city>Takatsuki</city>
        <state>Osaka</state>
        <zip>569-0852</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Wataru Nagamatsu</last_name>
    </contact>
    <investigator>
      <last_name>Wataru Nagamatsu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>SHUWA General Hospital</name>
      <address>
        <city>Kasukabe</city>
        <state>Saitama</state>
        <zip>344-0035</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ryo Goto</last_name>
    </contact>
    <investigator>
      <last_name>Ryo Goto, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kasukabe Chuo General Hospital</name>
      <address>
        <city>Kasukabe</city>
        <state>Saitama</state>
        <zip>344-0063</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Satoru Tohara</last_name>
    </contact>
    <investigator>
      <last_name>Satoru Tohara, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>TODA CHUO General Hospital</name>
      <address>
        <city>Toda</city>
        <state>Saitama</state>
        <zip>335-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yuichi Kobori</last_name>
    </contact>
    <investigator>
      <last_name>Yuichi Kobori, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seirei Mikatahara General Hospital</name>
      <address>
        <city>Hamamatsu</city>
        <state>Shizuoka</state>
        <zip>433-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yasuyo Takeuchi</last_name>
    </contact>
    <investigator>
      <last_name>Yasuyo Takeuchi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ayase Heart Hospital</name>
      <address>
        <city>Adachi-ku</city>
        <state>Tokyo</state>
        <zip>120-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hidenari Hozawa</last_name>
    </contact>
    <investigator>
      <last_name>Hidenari Hozawa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tokyo Rinkai Hospital</name>
      <address>
        <city>Edogawa-ku</city>
        <state>Tokyo</state>
        <zip>134-0086</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Motoyuki Onikura</last_name>
    </contact>
    <investigator>
      <last_name>Motoyuki Onikura, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Itabashi Chuo Medical Center</name>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo</state>
        <zip>174-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hiroshi Ota</last_name>
    </contact>
    <investigator>
      <last_name>Hiroshi Ota, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Katsushika Medical Center</name>
      <address>
        <city>Katsushika-ku</city>
        <state>Tokyo</state>
        <zip>125-8506</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yoshiki Uehara</last_name>
    </contact>
    <investigator>
      <last_name>Yoshiki Uehara, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tokyo-Kita Social Insurance Hospital</name>
      <address>
        <city>Kita-ku</city>
        <state>Tokyo</state>
        <zip>115-0053</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yuya Nakagawa</last_name>
    </contact>
    <investigator>
      <last_name>Yuya Nakagawa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Cardiovascular Institute</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <zip>106-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yuji Oikawa</last_name>
    </contact>
    <investigator>
      <last_name>Yuji Oikawa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Police Hospital</name>
      <address>
        <city>Nakano-ku</city>
        <state>Tokyo</state>
        <zip>164-8541</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Masatoshi Suzuki</last_name>
    </contact>
    <investigator>
      <last_name>Masatoshi Suzuki, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Hiroo Hospital</name>
      <address>
        <city>Shibuya-ku</city>
        <state>Tokyo</state>
        <zip>150-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yasuhiro Tanabe</last_name>
    </contact>
    <investigator>
      <last_name>Yasuhiro Tanabe, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NTT Medical Center Tokyo</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo</state>
        <zip>141-8625</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Masashiro Matsushita</last_name>
    </contact>
    <investigator>
      <last_name>Masashiro Matsushita, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saiseikai Fukuoka General Hospital</name>
      <address>
        <city>Fukuoka</city>
        <zip>810-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Takeshi Serikawa</last_name>
    </contact>
    <investigator>
      <last_name>Takeshi Serikawa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saiseikai Kumamoto Hospital</name>
      <address>
        <city>Kumamoto</city>
        <zip>861-4193</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Eiji Taguchi</last_name>
    </contact>
    <investigator>
      <last_name>Eiji Taguchi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>August 21, 2012</last_update_submitted>
  <last_update_submitted_qc>August 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic total occlusion</keyword>
  <keyword>Bifurcation lesion</keyword>
  <keyword>Left main trunk lesion</keyword>
  <keyword>Small vessel disease</keyword>
  <keyword>Multi vessel disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chromium</mesh_term>
    <mesh_term>Everolimus</mesh_term>
  </intervention_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/NCT01670318
org study id: SPECIALIST Registry
nct id: NCT01670318
lead sponsor: 
has dmc: Yes
Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium
      everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the
      identical antiproliferative agent and polymer but with a novel platinum chromium scaffold
      designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity,
      radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex
      coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left
      main trunk disease, and small vessel diseases is still unknown.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
time frame: 12 month
measure: Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site
time frame: In hospital
measure: Target lesion revascularization
time frame: 12 month
measure: Target vessel revascularization
time frame: 12 month
measure: Myocardial infarction
time frame: 24 month
measure: Cardiac death
time frame: 24 month
measure: Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
time frame: 24 month
measure: Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)
time frame: 24 month
arm group label: platinum chromium everolimus-eluting stent
arm group type: Experimental
intervention type: Device
intervention name: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)
arm group label: platinum chromium everolimus-eluting stent
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yuji Oikawa, MD, PhD
role: Principal Investigator
affiliation: The Cardiovascular Institute
last name: Kenya Nasu, MD, FACC
role: Principal Investigator
affiliation: Toyohashi Heart Center
last name: Kenya Nasu, MD, FACC
phone: +81532373377
email: yuyatomoya@gmail.com
last name: Yuji Oikawa, MD,PｈD
phone: +81532373377
email: nasu@heart-center.or.jp
facility: 
status: Not yet recruiting
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country: Japan
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Chromium
mesh term: Everolimus