search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)
Sponsored by
The PCI Guideline Research Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Chronic total occlusion, Bifurcation lesion, Left main trunk lesion, Small vessel disease, Multi vessel disease

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aichi Medical University Hospital
  • Toyohashi Heart CenterRecruiting
  • Juntendo University Urayasu Hospital
  • Kokura Memorial Hospital
  • Hoshi General Hospital
  • Southern Tohoku Research Institute for Neuroscience
  • Gunma Prefectural Cardiovascular Center
  • Gunma University Hospital
  • Ota Memorial Hospital
  • Megumino Hospital
  • JA Hokkaido Engaru Kosei General Hospital
  • Nayoro City General Hospital
  • Sapporo Cardio Vascular Clinic
  • Kansai Rosai Hospital
  • Kakogawa East City Hospital
  • Kobe University Hospital
  • Tsukuba Medical Center Hospital
  • Yokohama Rosai Hospital
  • Yokohama City Minato Red Cross Hospital
  • Daini Okamoto General Hospital
  • Matsumoto Kyoritsu Hospital
  • Rinku General Medical Center
  • Hokusetsu General Hospital
  • SHUWA General Hospital
  • Kasukabe Chuo General Hospital
  • TODA CHUO General Hospital
  • Seirei Mikatahara General Hospital
  • Ayase Heart Hospital
  • Tokyo Rinkai Hospital
  • Itabashi Chuo Medical Center
  • Katsushika Medical Center
  • Tokyo-Kita Social Insurance Hospital
  • The Cardiovascular Institute
  • Tokyo Metropolitan Police Hospital
  • Tokyo Metropolitan Hiroo Hospital
  • NTT Medical Center Tokyo
  • Saiseikai Fukuoka General Hospital
  • Saiseikai Kumamoto Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

platinum chromium everolimus-eluting stent

Arm Description

Outcomes

Primary Outcome Measures

Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization

Secondary Outcome Measures

Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site
Target lesion revascularization
Target vessel revascularization
Myocardial infarction
Cardiac death
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)

Full Information

First Posted
August 16, 2012
Last Updated
August 21, 2012
Sponsor
The PCI Guideline Research Society
search

1. Study Identification

Unique Protocol Identification Number
NCT01670318
Brief Title
Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
Acronym
SPECIALIST
Official Title
Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The PCI Guideline Research Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Chronic total occlusion, Bifurcation lesion, Left main trunk lesion, Small vessel disease, Multi vessel disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
platinum chromium everolimus-eluting stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)
Primary Outcome Measure Information:
Title
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site
Time Frame
In hospital
Title
Target lesion revascularization
Time Frame
12 month
Title
Target vessel revascularization
Time Frame
12 month
Title
Myocardial infarction
Time Frame
24 month
Title
Cardiac death
Time Frame
24 month
Title
Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization
Time Frame
24 month
Title
Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC)
Time Frame
24 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome Male or non-pregnant female Key lesion inclusion criteria as follows Multi-vessel diseases Long lesion (lesion length >30mm by visual estimation) Small vessel disease (reference diameter <2.5mm by visual estimation) Bifurcation lesion Ostial lesion Calcified lesion Protected or non-protected left main trunk disease Chronic total occlusion In stent restenosis of bare metal stent or everolimus-eluting stent Exclusion Criteria: Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media. Serum creatinine level >3.0 mg/dL Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenya Nasu, MD, FACC
Phone
+81532373377
Email
yuyatomoya@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuji Oikawa, MD,PｈD
Phone
+81532373377
Email
nasu@heart-center.or.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuji Oikawa, MD, PhD
Organizational Affiliation
The Cardiovascular Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenya Nasu, MD, FACC
Organizational Affiliation
Toyohashi Heart Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aichi Medical University Hospital
City
Nagakute
State/Province
Aichi
ZIP/Postal Code
480-1195
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroaki Takashima
First Name & Middle Initial & Last Name & Degree
Hiroaki Takashima, MD
Facility Name
Toyohashi Heart Center
City
Toyohashi
State/Province
Aichi
ZIP/Postal Code
441-8530
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenya Nasu, MD
First Name & Middle Initial & Last Name & Degree
Kenya Nasu, MD
Facility Name
Juntendo University Urayasu Hospital
City
Urayasu
State/Province
Chiba
ZIP/Postal Code
279-0021
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Yokoyama
First Name & Middle Initial & Last Name & Degree
Ken Tokoyama, MD
Facility Name
Kokura Memorial Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shinichi Shirai
First Name & Middle Initial & Last Name & Degree
Shinichi Shirai, MD
Facility Name
Hoshi General Hospital
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8501
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuichi Ujiie
First Name & Middle Initial & Last Name & Degree
Yuichi Ujiie, MD
Facility Name
Southern Tohoku Research Institute for Neuroscience
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
963-8563
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitsuru Muto
First Name & Middle Initial & Last Name & Degree
Muto Mitsuru, MD
Facility Name
Gunma Prefectural Cardiovascular Center
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-0004
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ren Kawaguchi
First Name & Middle Initial & Last Name & Degree
Ren Kawaguchi, MD
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryuichi Funada
First Name & Middle Initial & Last Name & Degree
Ryuichi Funada, MD
Facility Name
Ota Memorial Hospital
City
Ota
State/Province
Gunma
ZIP/Postal Code
373-8585
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hidetoshi Anzai
First Name & Middle Initial & Last Name & Degree
Hidetoshi Anzai, MD
Facility Name
Megumino Hospital
City
Eniwa
State/Province
Hokkaido
ZIP/Postal Code
061-1395
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noriko Makiguchi
First Name & Middle Initial & Last Name & Degree
Noriko Makiguchi, MD
Facility Name
JA Hokkaido Engaru Kosei General Hospital
City
Monbetsu
State/Province
Hokkaido
ZIP/Postal Code
099-0404
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takahide Suzuki
First Name & Middle Initial & Last Name & Degree
Takahide Suzuki, MD
Facility Name
Nayoro City General Hospital
City
Nayoro
State/Province
Hokkaido
ZIP/Postal Code
096-8511
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaru Yamaki
First Name & Middle Initial & Last Name & Degree
Masaru Yamaki, MD
Facility Name
Sapporo Cardio Vascular Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
007-0849
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshifumi Kashima
First Name & Middle Initial & Last Name & Degree
Yoshifumi Kashima, MD
Facility Name
Kansai Rosai Hospital
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8511
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaki Awata
First Name & Middle Initial & Last Name & Degree
Masaki Awata, MD
Facility Name
Kakogawa East City Hospital
City
Kakogawa
State/Province
Hyogo
ZIP/Postal Code
685-0115
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Makoto Kadotani
First Name & Middle Initial & Last Name & Degree
Makoto Kadotani, MD
Facility Name
Kobe University Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshiro Shinke
First Name & Middle Initial & Last Name & Degree
Toshiro Shinke, MD
Facility Name
Tsukuba Medical Center Hospital
City
Tsukuba
State/Province
Ibaragi
ZIP/Postal Code
305-8558
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hidetaka Nishina
First Name & Middle Initial & Last Name & Degree
Hidetaka Nishina, MD
Facility Name
Yokohama Rosai Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
222-0036
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuhiko Yumoto
First Name & Middle Initial & Last Name & Degree
Kazuhiko YUmoto, MD
Facility Name
Yokohama City Minato Red Cross Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsukasa Shimura
First Name & Middle Initial & Last Name & Degree
Tsukasa Shimura, MD
Facility Name
Daini Okamoto General Hospital
City
Uji
State/Province
Kyoto
ZIP/Postal Code
611-0025
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masaki Tanabe
First Name & Middle Initial & Last Name & Degree
Masaki Tanabe, MD
Facility Name
Matsumoto Kyoritsu Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8505
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hidetoshi Abe
First Name & Middle Initial & Last Name & Degree
Hidetoshi Abe, MD
Facility Name
Rinku General Medical Center
City
Izumisano
State/Province
Osaka
ZIP/Postal Code
598-8577
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshihiro Takeda
First Name & Middle Initial & Last Name & Degree
Yoshihiro Takeda, MD
Facility Name
Hokusetsu General Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-0852
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wataru Nagamatsu
First Name & Middle Initial & Last Name & Degree
Wataru Nagamatsu, MD
Facility Name
SHUWA General Hospital
City
Kasukabe
State/Province
Saitama
ZIP/Postal Code
344-0035
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryo Goto
First Name & Middle Initial & Last Name & Degree
Ryo Goto, MD
Facility Name
Kasukabe Chuo General Hospital
City
Kasukabe
State/Province
Saitama
ZIP/Postal Code
344-0063
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satoru Tohara
First Name & Middle Initial & Last Name & Degree
Satoru Tohara, MD
Facility Name
TODA CHUO General Hospital
City
Toda
State/Province
Saitama
ZIP/Postal Code
335-0023
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuichi Kobori
First Name & Middle Initial & Last Name & Degree
Yuichi Kobori, MD
Facility Name
Seirei Mikatahara General Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
433-8558
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuyo Takeuchi
First Name & Middle Initial & Last Name & Degree
Yasuyo Takeuchi, MD
Facility Name
Ayase Heart Hospital
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
120-0006
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hidenari Hozawa
First Name & Middle Initial & Last Name & Degree
Hidenari Hozawa, MD
Facility Name
Tokyo Rinkai Hospital
City
Edogawa-ku
State/Province
Tokyo
ZIP/Postal Code
134-0086
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Motoyuki Onikura
First Name & Middle Initial & Last Name & Degree
Motoyuki Onikura, MD
Facility Name
Itabashi Chuo Medical Center
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
174-0051
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Ota
First Name & Middle Initial & Last Name & Degree
Hiroshi Ota, MD
Facility Name
Katsushika Medical Center
City
Katsushika-ku
State/Province
Tokyo
ZIP/Postal Code
125-8506
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshiki Uehara
First Name & Middle Initial & Last Name & Degree
Yoshiki Uehara, MD
Facility Name
Tokyo-Kita Social Insurance Hospital
City
Kita-ku
State/Province
Tokyo
ZIP/Postal Code
115-0053
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuya Nakagawa
First Name & Middle Initial & Last Name & Degree
Yuya Nakagawa, MD
Facility Name
The Cardiovascular Institute
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
106-0031
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuji Oikawa
First Name & Middle Initial & Last Name & Degree
Yuji Oikawa, MD
Facility Name
Tokyo Metropolitan Police Hospital
City
Nakano-ku
State/Province
Tokyo
ZIP/Postal Code
164-8541
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masatoshi Suzuki
First Name & Middle Initial & Last Name & Degree
Masatoshi Suzuki, MD
Facility Name
Tokyo Metropolitan Hiroo Hospital
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-0013
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuhiro Tanabe
First Name & Middle Initial & Last Name & Degree
Yasuhiro Tanabe, MD
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masashiro Matsushita
First Name & Middle Initial & Last Name & Degree
Masashiro Matsushita, MD
Facility Name
Saiseikai Fukuoka General Hospital
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takeshi Serikawa
First Name & Middle Initial & Last Name & Degree
Takeshi Serikawa, MD
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eiji Taguchi
First Name & Middle Initial & Last Name & Degree
Eiji Taguchi, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs