Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets (SPECIALIST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by The PCI Guideline Research Society
Sponsor:
Information provided by (Responsible Party):
The PCI Guideline Research Society
ClinicalTrials.gov Identifier:
NCT01670318
First received: August 16, 2012
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets

Resource links provided by NLM:


Further study details as provided by The PCI Guideline Research Society:

Primary Outcome Measures:
  • Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site [ Time Frame: In hospital ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Target vessel revascularization [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Cardiac death [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization [ Time Frame: 24 month ] [ Designated as safety issue: No ]
  • Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC) [ Time Frame: 24 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: platinum chromium everolimus-eluting stent Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome
  2. Male or non-pregnant female
  3. Key lesion inclusion criteria as follows

    1. Multi-vessel diseases
    2. Long lesion (lesion length >30mm by visual estimation)
    3. Small vessel disease (reference diameter <2.5mm by visual estimation)
    4. Bifurcation lesion
    5. Ostial lesion
    6. Calcified lesion
    7. Protected or non-protected left main trunk disease
    8. Chronic total occlusion
    9. In stent restenosis of bare metal stent or everolimus-eluting stent

Exclusion Criteria:

  1. Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media.
  2. Serum creatinine level >3.0 mg/dL
  3. Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670318

Contacts
Contact: Kenya Nasu, MD, FACC +81532373377 yuyatomoya@gmail.com
Contact: Yuji Oikawa, MD,PhD +81532373377 nasu@heart-center.or.jp

Locations
Japan
Aichi Medical University Hospital Not yet recruiting
Nagakute, Aichi, Japan, 480-1195
Contact: Hiroaki Takashima         
Principal Investigator: Hiroaki Takashima, MD         
Toyohashi Heart Center Recruiting
Toyohashi, Aichi, Japan, 441-8530
Contact: Kenya Nasu, MD         
Principal Investigator: Kenya Nasu, MD         
Juntendo University Urayasu Hospital Not yet recruiting
Urayasu, Chiba, Japan, 279-0021
Contact: Ken Yokoyama         
Principal Investigator: Ken Tokoyama, MD         
Kokura Memorial Hospital Not yet recruiting
Kitakyushu, Fukuoka, Japan, 802-8555
Contact: Shinichi Shirai         
Principal Investigator: Shinichi Shirai, MD         
Hoshi General Hospital Not yet recruiting
Koriyama, Fukushima, Japan, 963-8501
Contact: Yuichi Ujiie         
Sub-Investigator: Yuichi Ujiie, MD         
Southern Tohoku Research Institute for Neuroscience Not yet recruiting
Koriyama, Fukushima, Japan, 963-8563
Contact: Mitsuru Muto         
Principal Investigator: Muto Mitsuru, MD         
Gunma Prefectural Cardiovascular Center Not yet recruiting
Maebashi, Gunma, Japan, 371-0004
Contact: Ren Kawaguchi         
Principal Investigator: Ren Kawaguchi, MD         
Gunma University Hospital Not yet recruiting
Maebashi, Gunma, Japan, 371-8511
Contact: Ryuichi Funada         
Principal Investigator: Ryuichi Funada, MD         
Ota Memorial Hospital Not yet recruiting
Ota, Gunma, Japan, 373-8585
Contact: Hidetoshi Anzai         
Principal Investigator: Hidetoshi Anzai, MD         
Megumino Hospital Not yet recruiting
Eniwa, Hokkaido, Japan, 061-1395
Contact: Noriko Makiguchi         
Principal Investigator: Noriko Makiguchi, MD         
JA Hokkaido Engaru Kosei General Hospital Not yet recruiting
Monbetsu, Hokkaido, Japan, 099-0404
Contact: Takahide Suzuki         
Principal Investigator: Takahide Suzuki, MD         
Nayoro City General Hospital Not yet recruiting
Nayoro, Hokkaido, Japan, 096-8511
Contact: Masaru Yamaki         
Principal Investigator: Masaru Yamaki, MD         
Sapporo Cardio Vascular Clinic Not yet recruiting
Sapporo, Hokkaido, Japan, 007-0849
Contact: Yoshifumi Kashima         
Principal Investigator: Yoshifumi Kashima, MD         
Kansai Rosai Hospital Not yet recruiting
Amagasaki, Hyogo, Japan, 660-8511
Contact: Masaki Awata         
Principal Investigator: Masaki Awata, MD         
Kakogawa East City Hospital Not yet recruiting
Kakogawa, Hyogo, Japan, 685-0115
Contact: Makoto Kadotani         
Principal Investigator: Makoto Kadotani, MD         
Kobe University Hospital Not yet recruiting
Kobe, Hyogo, Japan, 650-0017
Contact: Toshiro Shinke         
Principal Investigator: Toshiro Shinke, MD         
Tsukuba Medical Center Hospital Not yet recruiting
Tsukuba, Ibaragi, Japan, 305-8558
Contact: Hidetaka Nishina         
Principal Investigator: Hidetaka Nishina, MD         
Yokohama City Minato Red Cross Hospital Not yet recruiting
Yokohama, Kanagawa, Japan, 231-8682
Contact: Tsukasa Shimura         
Principal Investigator: Tsukasa Shimura, MD         
Yokohama Rosai Hospital Not yet recruiting
Yokohama, Kanagawa, Japan, 222-0036
Contact: Kazuhiko Yumoto         
Principal Investigator: Kazuhiko YUmoto, MD         
Daini Okamoto General Hospital Not yet recruiting
Uji, Kyoto, Japan, 611-0025
Contact: Masaki Tanabe         
Principal Investigator: Masaki Tanabe, MD         
Matsumoto Kyoritsu Hospital Not yet recruiting
Matsumoto, Nagano, Japan, 390-8505
Contact: Hidetoshi Abe         
Principal Investigator: Hidetoshi Abe, MD         
Rinku General Medical Center Not yet recruiting
Izumisano, Osaka, Japan, 598-8577
Contact: Yoshihiro Takeda         
Principal Investigator: Yoshihiro Takeda, MD         
Hokusetsu General Hospital Not yet recruiting
Takatsuki, Osaka, Japan, 569-0852
Contact: Wataru Nagamatsu         
Principal Investigator: Wataru Nagamatsu, MD         
SHUWA General Hospital Not yet recruiting
Kasukabe, Saitama, Japan, 344-0035
Contact: Ryo Goto         
Principal Investigator: Ryo Goto, MD         
Kasukabe Chuo General Hospital Not yet recruiting
Kasukabe, Saitama, Japan, 344-0063
Contact: Satoru Tohara         
Principal Investigator: Satoru Tohara, MD         
TODA CHUO General Hospital Not yet recruiting
Toda, Saitama, Japan, 335-0023
Contact: Yuichi Kobori         
Principal Investigator: Yuichi Kobori, MD         
Seirei Mikatahara General Hospital Not yet recruiting
Hamamatsu, Shizuoka, Japan, 433-8558
Contact: Yasuyo Takeuchi         
Principal Investigator: Yasuyo Takeuchi, MD         
Ayase Heart Hospital Not yet recruiting
Adachi-ku, Tokyo, Japan, 120-0006
Contact: Hidenari Hozawa         
Principal Investigator: Hidenari Hozawa, MD         
Tokyo Rinkai Hospital Not yet recruiting
Edogawa-ku, Tokyo, Japan, 134-0086
Contact: Motoyuki Onikura         
Principal Investigator: Motoyuki Onikura, MD         
Itabashi Chuo Medical Center Not yet recruiting
Itabashi-ku, Tokyo, Japan, 174-0051
Contact: Hiroshi Ota         
Principal Investigator: Hiroshi Ota, MD         
Katsushika Medical Center Not yet recruiting
Katsushika-ku, Tokyo, Japan, 125-8506
Contact: Yoshiki Uehara         
Principal Investigator: Yoshiki Uehara, MD         
Tokyo-Kita Social Insurance Hospital Not yet recruiting
Kita-ku, Tokyo, Japan, 115-0053
Contact: Yuya Nakagawa         
Principal Investigator: Yuya Nakagawa, MD         
The Cardiovascular Institute Not yet recruiting
Minato-ku, Tokyo, Japan, 106-0031
Contact: Yuji Oikawa         
Principal Investigator: Yuji Oikawa, MD         
Tokyo Metropolitan Police Hospital Not yet recruiting
Nakano-ku, Tokyo, Japan, 164-8541
Contact: Masatoshi Suzuki         
Principal Investigator: Masatoshi Suzuki, MD         
Tokyo Metropolitan Hiroo Hospital Not yet recruiting
Shibuya-ku, Tokyo, Japan, 150-0013
Contact: Yasuhiro Tanabe         
Principal Investigator: Yasuhiro Tanabe, MD         
NTT Medical Center Tokyo Not yet recruiting
Shinagawa-ku, Tokyo, Japan, 141-8625
Contact: Masashiro Matsushita         
Principal Investigator: Masashiro Matsushita, MD         
Saiseikai Fukuoka General Hospital Not yet recruiting
Fukuoka, Japan, 810-0001
Contact: Takeshi Serikawa         
Principal Investigator: Takeshi Serikawa, MD         
Saiseikai Kumamoto Hospital Not yet recruiting
Kumamoto, Japan, 861-4193
Contact: Eiji Taguchi         
Principal Investigator: Eiji Taguchi, MD         
Sponsors and Collaborators
The PCI Guideline Research Society
Investigators
Principal Investigator: Yuji Oikawa, MD, PhD The Cardiovascular Institute
Principal Investigator: Kenya Nasu, MD, FACC Toyohashi Heart Center
  More Information

No publications provided

Responsible Party: The PCI Guideline Research Society
ClinicalTrials.gov Identifier: NCT01670318     History of Changes
Other Study ID Numbers: SPECIALIST Registry
Study First Received: August 16, 2012
Last Updated: August 21, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by The PCI Guideline Research Society:
Chronic total occlusion
Bifurcation lesion
Left main trunk lesion
Small vessel disease
Multi vessel disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Chromium
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 18, 2014