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Japan-Drug Eluting Stents Evaluation; a Randomized Trial (J-DESsERT®)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
TAXUS stent
Cypher stent
Sponsored by
Associations for Establishment of Evidence in Interventions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Patient is ≥ 20 years old
  • Patient suitable for percutaneous coronary intervention (PCI)
  • Patient with signed informed consent
  • Patient judged suitable to receive anti-platelet drugs (clopidogrel bisulfate or ticlopidine hydrochloride, etc.) in principle for at least 6 months after procedure, and ideally up to 12 months in patients who are not at high risk of bleeding, based on ACC/AHA guideline
  • Patient with up to 3 lesions (with ≥ 50% of stenosis) in the maximum of 2 targeted vessels to be treated at once
  • Patient with reference vessel diameter (RVD) of 2.5 mm to 3.75 mm by visual observation
  • Patient with length of each lesion of up to 46 mm by visual assessment
  • Patient eligible for implementation of drug eluting stent.

Exclusion Criteria:

  • Patient with any planned treatment in the targeted vessel with a drug eluting stent other than in this study
  • Patient with acute myocardial infarction (AMI) (including non-ST segment elevation MI) developed within 7 days before the procedure
  • Patient participating in a currently ongoing registry or clinical study, or receiving a treatment which may affect the endpoints of this study
  • Patient of childbearing potential with a positive pregnancy test within 14 days before the procedure, or lactating
  • Patient who has history of allergy against Sirolimus, Paclitaxel, polymers or stainless steel
  • Patient who has history of side-effect against anti-platelet drugs or anti-coagulation drugs
  • Patient with serious hepatic dysfunction
  • Patient with left ventriculogram ejection fraction of 35% or less
  • Patient with three target vessels in need of PCI treatment
  • Patient with serious renal dysfunction (serum creatinine value 2mg/dL or higher)
  • Patient currently receiving artificial dialysis
  • Patient with a malignant tumor (cancer) diagnosed within 5 years before the procedure
  • Patient who has received PCI treatment within the past one year
  • Patient with chronic total occlusion (CTO) or TIMI flow 2 or less
  • Patient with >50% stenosis in left main coronary artery
  • Patient with >50% stenosis in side branch ostial for which stenting in the side branch lesion is required (KBT for side branch is accepted)
  • Patient with in-stent restenosis in the target lesion implanted with a bare-metal or drug eluting stent
  • Patient who has target lesion in saphenous vein graft
  • Patient judged non-eligible by the physician in charge.

Sites / Locations

  • Aichi Medical University Hospital
  • Japan Labour Health and Welfare Organization, Kansai Rosai Hospital
  • Asahikawa-Kosei General Hospital
  • Sakakibara Memorial Hospital
  • Fukui Cardiovascular Center
  • Fukuoka University Hospital
  • Gifu Prefectural General Medical Center
  • Seirei Hamamatsu General Hospital
  • Hekinan Municipal Hospital
  • Saitama Medical University International Medical Center
  • Koto Memorial Hospital
  • Kansai Medical University Hirakata Hospital
  • Hiratsuka Kyosai Hospital
  • Hirosaki University School of Medicine and Hospital
  • Hiroshima University Hospital
  • Tsuchiya General Hospital
  • Iizuka Hospital
  • Saiseikai Imabari Hospital
  • Nippon Medical School Chiba Hokusoh Hospital
  • Iwaki Kyoritsu Hospital
  • Rinku General Medical Center
  • Juntendo University Shizuoka Hospital
  • Setsunan General Hospital
  • Ishikawa Prefectural Central Hospital
  • Kanazawa Cardiovascular Hospital
  • Nara Medical University Hospital
  • Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
  • Kawasaki Saiwai Hospital
  • Kagawa University Hospital
  • Kimitsu Chuo Hospital
  • Kokura Memorial Hospital
  • Kobe University Hospital
  • Chikamori Hospital
  • Hoshi General Hospital
  • Kumamoto Chuo Hospital
  • Saiseikai Kumamoto Hospital
  • Kawasaki Medical School Hospital
  • Kurume University Hospital
  • St.Mary's Hospital
  • Japanese Red Cross Kyoto Daini Hospital
  • Koseikai Takeda Hospital
  • Kyoto-Katsura Hospital
  • Mie Heart Center
  • Miki City Hospital
  • Miyazaki Medical Association Hospital
  • Memorial Heart Center Iwate Medical University
  • Shiga Medical Center for Adults
  • Musashino Red Cross Hospital
  • Tachikawa General Hospital
  • Kouseikai Hospital
  • Nagoya daiichi red cross Hospital
  • Nagoya Daini Red Cross Hospital
  • Nagoya Memorial Hospital
  • Ogaki Municipal Hospital
  • Oita Cardiovascular Hospital
  • OitaOka Hospital
  • Okayama Red Cross General Hospital
  • Okayama University Hospital
  • Sakakibara Heart Institute of Okayama
  • Omihachiman Community Medical Center
  • National Hospital Organization Osaka National Hospital
  • Osaka City University Hospital
  • Osaka General Medical Center
  • Osaka Police Hospital
  • Kitasato University Hospital
  • Iwatsuki-minami Hospital
  • Japan Labour Health and Welfare Organization, Osaka Rosai Hospital
  • Caress Sapporo Hokko Memorial Hospital
  • Caress Sapporo Tokeidai Hospital
  • Hokkaido Social Insurance Hospital
  • Sapporo Orthopaedic Cardio-vascular Hospital
  • Teine Keijinkai Hospital
  • Sendai Kousei Hospital
  • Sendai Open Hospital
  • Tohoku Koseinenkin Hospital
  • Jichi Medical University Hospital
  • National Cerebral and Cardiovascular Center
  • Osaka University Graduate School of Medicine
  • Kagawa Prefectural Central Hospital
  • Ayase Heart Hospital
  • Edogawa Hospital
  • Itabashi Chuo Medical Center
  • Jikei University Hospital
  • Juntendo University Hospital
  • Juntendo University Nerima Hospital
  • Kanto Medical Center NTT EC
  • Keio University Hospital
  • Mitsui Memorial Hospital
  • Nihon University School of Medicine Itabashi Hospital
  • Nippon Medical School Hospital
  • Showa University Hospital
  • St. Luke's International Hospital
  • Teikyo University Hospital
  • The Cardiovascular Institute Hospital
  • Toho University Ohashi Medical Center
  • Toho University Omori Medical Center
  • Tokyo Medical University Hospital
  • Tokyo Metropolitan Hiroo Hospital
  • Tokyo Women's Medical University Hospital
  • Toranomon Hospital
  • Tomishiro Central Hospital
  • Toyama Prefectural Central Hospital
  • Toyama Red Cross Hospital
  • Fujita Health University Hospital
  • Toyohashi Heart Center
  • Tsuchiura Kyodo Hospital
  • Tsuyama Central Hospital
  • Uwajima City Hospital
  • Wakayama Medical University Hospital
  • Yamagata Prefectural Central Hospital
  • Saiseikai Yamaguchi Hospital
  • Japan Labour Health and Welfare Organization, Kumamoto Rosai hospital
  • Japan Labour Health and Welfare Organization, Yokohama Rosai Hospital
  • Kanagawa Cardiovascular and Respiratory Center
  • Kikuna Memorial Hospital
  • Saiseikai Yokohamashi Tobu Hospital
  • Showa University Fujigaoka Hospital
  • Showa University Northern Yokohama Hospital
  • Yokohama City University General Medical Center
  • Yokohama Sakae Kyosai Hospital
  • Yokosuka General Hospital Uwamachi
  • Tottori University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TAXUS group

Cypher group

Arm Description

Outcomes

Primary Outcome Measures

Target Vessel Failure (TVF) at 8 months post-procedure(assessed prior to routine angiography) in Overall study population

Secondary Outcome Measures

Target Vessel Failure (TVF) at 8 months post-procedure (assessed prior to routine angiography) in diabetic group

Full Information

First Posted
June 30, 2008
Last Updated
November 4, 2014
Sponsor
Associations for Establishment of Evidence in Interventions
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1. Study Identification

Unique Protocol Identification Number
NCT00708669
Brief Title
Japan-Drug Eluting Stents Evaluation; a Randomized Trial
Acronym
J-DESsERT®
Official Title
A Japanese Prospective, Randomized, Multi-center Trial Comparing the TAXUS Stent and the CYPHER Stent in Patients With Coronary Artery Disease Eligible for PCI.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Associations for Establishment of Evidence in Interventions

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the procedural, short and long term clinical outcomes of the TAXUS stent compared to Cypher stent in coronary arteries of ≥ 2.5 and ≤ 3.75 mm in the reference vessel diameter with a lesion of ≤ 46 mm (by visual observation) in routine clinical settings in Japan.
Detailed Description
In these days, meta-analyses have been conducted in large scale and small scale studies, but there has been no conclusion yet stating which one of the stents, either Cypher stent or TAXUS stent, is superior to the other. In specific disease condition such as in diabetic patients, it has been reported that Paclitaxel (TAXUS stent) is more suitable than Sirolimus (Cypher stent), due to the difference in the action mechanisms of the drugs. Since TAXUS stent was recently approved in Japan, we decided to conduct a randomized multi-center comparative study to compare Cypher stent and TAXUS stent regarding the clinical endpoint (target vessel failure for 8 months). The study is powered to show equivalence between the 2 stents in all patients, and to show superiority of the TAXUS stent in the diabetic patient population. In addition, for selected patients, quantitative coronary angiography, intravascular ultrasound, optical coherence tomography, and angioscopy are performed to examine the difference of the two stents more closely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAXUS group
Arm Type
Active Comparator
Arm Title
Cypher group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
TAXUS stent
Intervention Description
Compared two kinds of stents:TAXUS stent, approved for commercialization in Japan(March 30th, 2007)
Intervention Type
Device
Intervention Name(s)
Cypher stent
Intervention Description
CYPHER stent, approved for commercialization in Japan(March 25, 2004)
Primary Outcome Measure Information:
Title
Target Vessel Failure (TVF) at 8 months post-procedure(assessed prior to routine angiography) in Overall study population
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Target Vessel Failure (TVF) at 8 months post-procedure (assessed prior to routine angiography) in diabetic group
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is ≥ 20 years old Patient suitable for percutaneous coronary intervention (PCI) Patient with signed informed consent Patient judged suitable to receive anti-platelet drugs (clopidogrel bisulfate or ticlopidine hydrochloride, etc.) in principle for at least 6 months after procedure, and ideally up to 12 months in patients who are not at high risk of bleeding, based on ACC/AHA guideline Patient with up to 3 lesions (with ≥ 50% of stenosis) in the maximum of 2 targeted vessels to be treated at once Patient with reference vessel diameter (RVD) of 2.5 mm to 3.75 mm by visual observation Patient with length of each lesion of up to 46 mm by visual assessment Patient eligible for implementation of drug eluting stent. Exclusion Criteria: Patient with any planned treatment in the targeted vessel with a drug eluting stent other than in this study Patient with acute myocardial infarction (AMI) (including non-ST segment elevation MI) developed within 7 days before the procedure Patient participating in a currently ongoing registry or clinical study, or receiving a treatment which may affect the endpoints of this study Patient of childbearing potential with a positive pregnancy test within 14 days before the procedure, or lactating Patient who has history of allergy against Sirolimus, Paclitaxel, polymers or stainless steel Patient who has history of side-effect against anti-platelet drugs or anti-coagulation drugs Patient with serious hepatic dysfunction Patient with left ventriculogram ejection fraction of 35% or less Patient with three target vessels in need of PCI treatment Patient with serious renal dysfunction (serum creatinine value 2mg/dL or higher) Patient currently receiving artificial dialysis Patient with a malignant tumor (cancer) diagnosed within 5 years before the procedure Patient who has received PCI treatment within the past one year Patient with chronic total occlusion (CTO) or TIMI flow 2 or less Patient with >50% stenosis in left main coronary artery Patient with >50% stenosis in side branch ostial for which stenting in the side branch lesion is required (KBT for side branch is accepted) Patient with in-stent restenosis in the target lesion implanted with a bare-metal or drug eluting stent Patient who has target lesion in saphenous vein graft Patient judged non-eligible by the physician in charge.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinsuke Nanto, M.D
Organizational Affiliation
Non-profit organization(NPO); "Associations for Establishment of Evidence in Intervations"
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Medical University Hospital
City
Aichi
Country
Japan
Facility Name
Japan Labour Health and Welfare Organization, Kansai Rosai Hospital
City
Amagasaki
Country
Japan
Facility Name
Asahikawa-Kosei General Hospital
City
Asahikawa
Country
Japan
Facility Name
Sakakibara Memorial Hospital
City
Fuchu
Country
Japan
Facility Name
Fukui Cardiovascular Center
City
Fukui
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka
Country
Japan
Facility Name
Gifu Prefectural General Medical Center
City
Gifu
Country
Japan
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
Country
Japan
Facility Name
Hekinan Municipal Hospital
City
Hekinan
Country
Japan
Facility Name
Saitama Medical University International Medical Center
City
Hidaka
Country
Japan
Facility Name
Koto Memorial Hospital
City
Higashiomi
Country
Japan
Facility Name
Kansai Medical University Hirakata Hospital
City
Hirakata
Country
Japan
Facility Name
Hiratsuka Kyosai Hospital
City
Hiratsuka
Country
Japan
Facility Name
Hirosaki University School of Medicine and Hospital
City
Hirosaki
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
Country
Japan
Facility Name
Tsuchiya General Hospital
City
Hiroshima
Country
Japan
Facility Name
Iizuka Hospital
City
Iizuka
Country
Japan
Facility Name
Saiseikai Imabari Hospital
City
Imabari
Country
Japan
Facility Name
Nippon Medical School Chiba Hokusoh Hospital
City
Inzai
Country
Japan
Facility Name
Iwaki Kyoritsu Hospital
City
Iwaki
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumisano
Country
Japan
Facility Name
Juntendo University Shizuoka Hospital
City
Izunokuni
Country
Japan
Facility Name
Setsunan General Hospital
City
Kadoma
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa
Country
Japan
Facility Name
Kanazawa Cardiovascular Hospital
City
Kanazawa
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
Country
Japan
Facility Name
Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
City
Kawasaki
Country
Japan
Facility Name
Kawasaki Saiwai Hospital
City
Kawasaki
Country
Japan
Facility Name
Kagawa University Hospital
City
Kida
Country
Japan
Facility Name
Kimitsu Chuo Hospital
City
Kisarazu
Country
Japan
Facility Name
Kokura Memorial Hospital
City
Kitakyusyu
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
Country
Japan
Facility Name
Chikamori Hospital
City
Kochi
Country
Japan
Facility Name
Hoshi General Hospital
City
Koriyama
Country
Japan
Facility Name
Kumamoto Chuo Hospital
City
Kumamoto
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto
Country
Japan
Facility Name
Kawasaki Medical School Hospital
City
Kurashiki
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
Country
Japan
Facility Name
St.Mary's Hospital
City
Kurume
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daini Hospital
City
Kyoto
Country
Japan
Facility Name
Koseikai Takeda Hospital
City
Kyoto
Country
Japan
Facility Name
Kyoto-Katsura Hospital
City
Kyoto
Country
Japan
Facility Name
Mie Heart Center
City
Mie
Country
Japan
Facility Name
Miki City Hospital
City
Miki
Country
Japan
Facility Name
Miyazaki Medical Association Hospital
City
Miyazaki
Country
Japan
Facility Name
Memorial Heart Center Iwate Medical University
City
Morioka
Country
Japan
Facility Name
Shiga Medical Center for Adults
City
Moriyama
Country
Japan
Facility Name
Musashino Red Cross Hospital
City
Musashino
Country
Japan
Facility Name
Tachikawa General Hospital
City
Nagaoka
Country
Japan
Facility Name
Kouseikai Hospital
City
Nagasaki
Country
Japan
Facility Name
Nagoya daiichi red cross Hospital
City
Nagoya
Country
Japan
Facility Name
Nagoya Daini Red Cross Hospital
City
Nagoya
Country
Japan
Facility Name
Nagoya Memorial Hospital
City
Nagoya
Country
Japan
Facility Name
Ogaki Municipal Hospital
City
Ogaki
Country
Japan
Facility Name
Oita Cardiovascular Hospital
City
Oita
Country
Japan
Facility Name
OitaOka Hospital
City
Oita
Country
Japan
Facility Name
Okayama Red Cross General Hospital
City
Okayama
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
Country
Japan
Facility Name
Sakakibara Heart Institute of Okayama
City
Okayama
Country
Japan
Facility Name
Omihachiman Community Medical Center
City
Omihachiman
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
Country
Japan
Facility Name
Osaka Police Hospital
City
Osaka
Country
Japan
Facility Name
Kitasato University Hospital
City
Sagamihara
Country
Japan
Facility Name
Iwatsuki-minami Hospital
City
Saitama
Country
Japan
Facility Name
Japan Labour Health and Welfare Organization, Osaka Rosai Hospital
City
Sakai
Country
Japan
Facility Name
Caress Sapporo Hokko Memorial Hospital
City
Sapporo
Country
Japan
Facility Name
Caress Sapporo Tokeidai Hospital
City
Sapporo
Country
Japan
Facility Name
Hokkaido Social Insurance Hospital
City
Sapporo
Country
Japan
Facility Name
Sapporo Orthopaedic Cardio-vascular Hospital
City
Sapporo
Country
Japan
Facility Name
Teine Keijinkai Hospital
City
Sapporo
Country
Japan
Facility Name
Sendai Kousei Hospital
City
Sendai
Country
Japan
Facility Name
Sendai Open Hospital
City
Sendai
Country
Japan
Facility Name
Tohoku Koseinenkin Hospital
City
Sendai
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Suita
Country
Japan
Facility Name
Osaka University Graduate School of Medicine
City
Suita
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu
Country
Japan
Facility Name
Ayase Heart Hospital
City
Tokyo
Country
Japan
Facility Name
Edogawa Hospital
City
Tokyo
Country
Japan
Facility Name
Itabashi Chuo Medical Center
City
Tokyo
Country
Japan
Facility Name
Jikei University Hospital
City
Tokyo
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
Country
Japan
Facility Name
Juntendo University Nerima Hospital
City
Tokyo
Country
Japan
Facility Name
Kanto Medical Center NTT EC
City
Tokyo
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
Country
Japan
Facility Name
Mitsui Memorial Hospital
City
Tokyo
Country
Japan
Facility Name
Nihon University School of Medicine Itabashi Hospital
City
Tokyo
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
Country
Japan
Facility Name
Showa University Hospital
City
Tokyo
Country
Japan
Facility Name
St. Luke's International Hospital
City
Tokyo
Country
Japan
Facility Name
Teikyo University Hospital
City
Tokyo
Country
Japan
Facility Name
The Cardiovascular Institute Hospital
City
Tokyo
Country
Japan
Facility Name
Toho University Ohashi Medical Center
City
Tokyo
Country
Japan
Facility Name
Toho University Omori Medical Center
City
Tokyo
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
Country
Japan
Facility Name
Tokyo Metropolitan Hiroo Hospital
City
Tokyo
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Tokyo
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
Country
Japan
Facility Name
Tomishiro Central Hospital
City
Tomishiro
Country
Japan
Facility Name
Toyama Prefectural Central Hospital
City
Toyama
Country
Japan
Facility Name
Toyama Red Cross Hospital
City
Toyama
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
Country
Japan
Facility Name
Toyohashi Heart Center
City
Toyohashi
Country
Japan
Facility Name
Tsuchiura Kyodo Hospital
City
Tsuchiura
Country
Japan
Facility Name
Tsuyama Central Hospital
City
Tsuyama
Country
Japan
Facility Name
Uwajima City Hospital
City
Uwajima
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata
Country
Japan
Facility Name
Saiseikai Yamaguchi Hospital
City
Yamaguchi
Country
Japan
Facility Name
Japan Labour Health and Welfare Organization, Kumamoto Rosai hospital
City
Yatsushiro
Country
Japan
Facility Name
Japan Labour Health and Welfare Organization, Yokohama Rosai Hospital
City
Yokohama
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Yokohama
Country
Japan
Facility Name
Kikuna Memorial Hospital
City
Yokohama
Country
Japan
Facility Name
Saiseikai Yokohamashi Tobu Hospital
City
Yokohama
Country
Japan
Facility Name
Showa University Fujigaoka Hospital
City
Yokohama
Country
Japan
Facility Name
Showa University Northern Yokohama Hospital
City
Yokohama
Country
Japan
Facility Name
Yokohama City University General Medical Center
City
Yokohama
Country
Japan
Facility Name
Yokohama Sakae Kyosai Hospital
City
Yokohama
Country
Japan
Facility Name
Yokosuka General Hospital Uwamachi
City
Yokosuka
Country
Japan
Facility Name
Tottori University Hospital
City
Yonago
Country
Japan

12. IPD Sharing Statement

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Japan-Drug Eluting Stents Evaluation; a Randomized Trial

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