Japan-Drug Eluting Stents Evaluation; a Randomized Trial
J-DESsERT®
A Japanese Prospective, Randomized, Multi-center Trial Comparing the TAXUS Stent and the CYPHER Stent in Patients With Coronary Artery Disease Eligible for PCI.
1 other identifier
interventional
3,500
1 country
122
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 30, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedNovember 5, 2014
April 1, 2012
5.5 years
June 30, 2008
November 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Target Vessel Failure (TVF) at 8 months post-procedure(assessed prior to routine angiography) in Overall study population
8 months
Secondary Outcomes (1)
Target Vessel Failure (TVF) at 8 months post-procedure (assessed prior to routine angiography) in diabetic group
8 months
Study Arms (2)
TAXUS group
ACTIVE COMPARATORCypher group
ACTIVE COMPARATORInterventions
Compared two kinds of stents:TAXUS stent, approved for commercialization in Japan(March 30th, 2007)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (122)
Aichi Medical University Hospital
Aichi, Japan
Japan Labour Health and Welfare Organization, Kansai Rosai Hospital
Amagasaki, Japan
Asahikawa-Kosei General Hospital
Asahikawa, Japan
Sakakibara Memorial Hospital
Fuchū, Japan
Fukui Cardiovascular Center
Fukui, Japan
Fukuoka University Hospital
Fukuoka, Japan
Gifu Prefectural General Medical Center
Gifu, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Japan
Hekinan Municipal Hospital
Hekinan, Japan
Saitama Medical University International Medical Center
Hidaka, Japan
Koto Memorial Hospital
Higashiōmi, Japan
Kansai Medical University Hirakata Hospital
Hirakata, Japan
Hiratsuka Kyosai Hospital
Hiratsuka, Japan
Hirosaki University School of Medicine and Hospital
Hirosaki, Japan
Hiroshima University Hospital
Hiroshima, Japan
Tsuchiya General Hospital
Hiroshima, Japan
Iizuka Hospital
Iizuka, Japan
Saiseikai Imabari Hospital
Imabari, Japan
Nippon Medical School Chiba Hokusoh Hospital
Inzai, Japan
Iwaki Kyoritsu Hospital
Iwaki, Japan
Rinku General Medical Center
Izumisano, Japan
Juntendo University Shizuoka Hospital
Izunokuni, Japan
Setsunan General Hospital
Kadoma, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Japan
Kanazawa Cardiovascular Hospital
Kanazawa, Japan
Nara Medical University Hospital
Kashihara, Japan
Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Kawasaki, Japan
Kawasaki Saiwai Hospital
Kawasaki, Japan
Kagawa University Hospital
Kida, Japan
Kimitsu Chuo Hospital
Kisarazu, Japan
Kokura Memorial Hospital
Kitakyushu, Japan
Kobe University Hospital
Kobe, Japan
Chikamori Hospital
Kochi, Japan
Hoshi General Hospital
Kōriyama, Japan
Kumamoto Chuo Hospital
Kumamoto, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Japan
Kawasaki Medical School Hospital
Kurashiki, Japan
Kurume University Hospital
Kurume, Japan
St.Mary's Hospital
Kurume, Japan
Japanese Red Cross Kyoto Daini Hospital
Kyoto, Japan
Koseikai Takeda Hospital
Kyoto, Japan
Kyoto-Katsura Hospital
Kyoto, Japan
Mie Heart Center
Mie, Japan
Miki City Hospital
Miki, Japan
Miyazaki Medical Association Hospital
Miyazaki, Japan
Memorial Heart Center Iwate Medical University
Morioka, Japan
Shiga Medical Center for Adults
Moriyama, Japan
Musashino Red Cross Hospital
Musashino, Japan
Tachikawa General Hospital
Nagaoka, Japan
Kouseikai Hospital
Nagasaki, Japan
Nagoya daiichi red cross Hospital
Nagoya, Japan
Nagoya Daini Red Cross Hospital
Nagoya, Japan
Nagoya Memorial Hospital
Nagoya, Japan
Okayama Red Cross General Hospital
Okayama, Japan
Okayama University Hospital
Okayama, Japan
Sakakibara Heart Institute of Okayama
Okayama, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Osaka City University Hospital
Osaka, Japan
Osaka General Medical Center
Osaka, Japan
Osaka Police Hospital
Osaka, Japan
Ogaki Municipal Hospital
Ōgaki, Japan
Oita Cardiovascular Hospital
Ōita, Japan
OitaOka Hospital
Ōita, Japan
Omihachiman Community Medical Center
Ōmihachiman, Japan
Kitasato University Hospital
Sagamihara, Japan
Iwatsuki-minami Hospital
Saitama, Japan
Japan Labour Health and Welfare Organization, Osaka Rosai Hospital
Sakai, Japan
Caress Sapporo Hokko Memorial Hospital
Sapporo, Japan
Caress Sapporo Tokeidai Hospital
Sapporo, Japan
Hokkaido Social Insurance Hospital
Sapporo, Japan
Sapporo Orthopaedic Cardio-vascular Hospital
Sapporo, Japan
Teine Keijinkai Hospital
Sapporo, Japan
Sendai Kousei Hospital
Sendai, Japan
Sendai Open Hospital
Sendai, Japan
Tohoku Koseinenkin Hospital
Sendai, Japan
Jichi Medical University Hospital
Shimotsuke, Japan
National Cerebral and Cardiovascular Center
Suita, Japan
Osaka University Graduate School of Medicine
Suita, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Japan
Ayase Heart Hospital
Tokyo, Japan
Edogawa Hospital
Tokyo, Japan
Itabashi Chuo Medical Center
Tokyo, Japan
Jikei University Hospital
Tokyo, Japan
Juntendo University Hospital
Tokyo, Japan
Juntendo University Nerima Hospital
Tokyo, Japan
Kanto Medical Center NTT EC
Tokyo, Japan
Keio University Hospital
Tokyo, Japan
Mitsui Memorial Hospital
Tokyo, Japan
Nihon University School of Medicine Itabashi Hospital
Tokyo, Japan
Nippon Medical School Hospital
Tokyo, Japan
Showa University Hospital
Tokyo, Japan
St. Luke's International Hospital
Tokyo, Japan
Teikyo University Hospital
Tokyo, Japan
The Cardiovascular Institute Hospital
Tokyo, Japan
Toho University Ohashi Medical Center
Tokyo, Japan
Toho University Omori Medical Center
Tokyo, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Tokyo Metropolitan Hiroo Hospital
Tokyo, Japan
Tokyo Women's Medical University Hospital
Tokyo, Japan
Toranomon Hospital
Tokyo, Japan
Tomishiro Central Hospital
Tomishiro, Japan
Toyama Prefectural Central Hospital
Toyama, Japan
Toyama Red Cross Hospital
Toyama, Japan
Fujita Health University Hospital
Toyoake, Japan
Toyohashi Heart Center
Toyohashi, Japan
Tsuchiura Kyodo Hospital
Tsuchiura, Japan
Tsuyama Central Hospital
Tsuyama, Japan
Uwajima City Hospital
Uwajima, Japan
Wakayama Medical University Hospital
Wakayama, Japan
Yamagata Prefectural Central Hospital
Yamagata, Japan
Saiseikai Yamaguchi Hospital
Yamaguchi, Japan
Japan Labour Health and Welfare Organization, Kumamoto Rosai hospital
Yatsushiro, Japan
Japan Labour Health and Welfare Organization, Yokohama Rosai Hospital
Yokohama, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Japan
Kikuna Memorial Hospital
Yokohama, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Japan
Showa University Fujigaoka Hospital
Yokohama, Japan
Showa University Northern Yokohama Hospital
Yokohama, Japan
Yokohama City University General Medical Center
Yokohama, Japan
Yokohama Sakae Kyosai Hospital
Yokohama, Japan
Yokosuka General Hospital Uwamachi
Yokosuka, Japan
Tottori University Hospital
Yonago, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shinsuke Nanto, M.D
Non-profit organization(NPO); "Associations for Establishment of Evidence in Intervations"
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 30, 2008
First Posted
July 2, 2008
Study Start
March 1, 2008
Primary Completion
September 1, 2013
Last Updated
November 5, 2014
Record last verified: 2012-04