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.

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: TAXUS stent; Device: Cypher stent

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.

• Study Type: Interventional
• Enrollment (Anticipated): 3500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
    • Aichi Medical University Hospital
  • Amagasaki, Japan
    • Japan Labour Health and Welfare Organization, Kansai Rosai Hospital
  • Asahikawa, Japan
    • Asahikawa-Kosei General Hospital
  • Fuchu, Japan
    • Sakakibara Memorial Hospital
  • Fukui, Japan
    • Fukui Cardiovascular Center
  • Fukuoka, Japan
    • Fukuoka University Hospital
  • Gifu, Japan
    • Gifu Prefectural General Medical Center
  • Hamamatsu, Japan
    • Seirei Hamamatsu General Hospital
  • Hekinan, Japan
    • Hekinan Municipal Hospital
  • Hidaka, Japan
    • Saitama Medical University International Medical Center
  • Higashiomi, Japan
    • Koto Memorial Hospital
  • Hirakata, Japan
    • Kansai Medical University Hirakata Hospital
  • Hiratsuka, Japan
    • Hiratsuka Kyosai Hospital
  • Hirosaki, Japan
    • Hirosaki University School of Medicine and Hospital
  • Hiroshima, Japan
    • Hiroshima University Hospital
  • Hiroshima, Japan
    • Tsuchiya General Hospital
  • Iizuka, Japan
    • Iizuka Hospital
  • Imabari, Japan
    • Saiseikai Imabari Hospital
  • Inzai, Japan
    • Nippon Medical School Chiba Hokusoh Hospital
  • Iwaki, Japan
    • Iwaki Kyoritsu Hospital
  • Izumisano, Japan
    • Rinku General Medical Center
  • Izunokuni, Japan
    • Juntendo University Shizuoka Hospital
  • Kadoma, Japan
    • Setsunan General Hospital
  • Kanazawa, Japan
    • Ishikawa Prefectural Central Hospital
  • Kanazawa, Japan
    • Kanazawa Cardiovascular Hospital
  • Kashihara, Japan
    • Nara Medical University Hospital
  • Kawasaki, Japan
    • Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
  • Kawasaki, Japan
    • Kawasaki Saiwai Hospital
  • Kida, Japan
    • Kagawa University Hospital
  • Kisarazu, Japan
    • Kimitsu Chuo Hospital
  • Kitakyusyu, Japan
    • Kokura Memorial Hospital
  • Kobe, Japan
    • Kobe University Hospital
  • Kochi, Japan
    • Chikamori Hospital
  • Koriyama, Japan
    • Hoshi general hospital
  • Kumamoto, Japan
    • Saiseikai Kumamoto Hospital
  • Kumamoto, Japan
    • Kumamoto Chuo Hospital
  • Kurashiki, Japan
    • Kawasaki Medical School Hospital
  • Kurume, Japan
    • Kurume University Hospital
  • Kurume, Japan
    • St.Mary's Hospital
  • Kyoto, Japan
    • Japanese Red Cross Kyoto Daini Hospital
  • Kyoto, Japan
    • Koseikai Takeda Hospital
  • Kyoto, Japan
    • Kyoto-Katsura Hospital
  • Mie, Japan
    • Mie Heart Center
  • Miki, Japan
    • Miki City Hospital
  • Miyazaki, Japan
    • Miyazaki Medical Association Hospital
  • Morioka, Japan
    • Memorial Heart Center Iwate Medical University
  • Moriyama, Japan
    • Shiga Medical Center for Adults
  • Musashino, Japan
    • Musashino Red Cross Hospital
  • Nagaoka, Japan
    • Tachikawa General Hospital
  • Nagasaki, Japan
    • Kouseikai Hospital
  • Nagoya, Japan
    • Nagoya daiichi red cross Hospital
  • Nagoya, Japan
    • Nagoya Daini Red Cross Hospital
  • Nagoya, Japan
    • Nagoya Memorial Hospital
  • Ogaki, Japan
    • Ogaki Municipal Hospital
  • Oita, Japan
    • Oita Cardiovascular Hospital
  • Oita, Japan
    • OitaOka Hospital
  • Okayama, Japan
    • Okayama University Hospital
  • Okayama, Japan
    • Okayama Red Cross General Hospital
  • Okayama, Japan
    • Sakakibara Heart Institute of Okayama
  • Omihachiman, Japan
    • Omihachiman Community Medical Center
  • Osaka, Japan
    • Osaka General Medical Center
  • Osaka, Japan
    • Osaka Police Hospital
  • Osaka, Japan
    • National Hospital Organization Osaka National Hospital
  • Osaka, Japan
    • Osaka City University Hospital
  • Sagamihara, Japan
    • Kitasato University Hospital
  • Saitama, Japan
    • Iwatsuki-minami Hospital
  • Sakai, Japan
    • Japan Labour Health and Welfare Organization, Osaka Rosai Hospital
  • Sapporo, 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
  • Sendai, Japan
    • Sendai Kousei Hospital
  • Sendai, Japan
    • Sendai Open Hospital
  • Sendai, Japan
    • Tohoku Koseinenkin Hospital
  • Shimotsuke, Japan
    • Jichi Medical University Hospital
  • Suita, Japan
    • National Cerebral and Cardiovascular Center
  • Suita, Japan
    • Osaka University Graduate School of Medicine
  • Takamatsu, Japan
    • Kagawa Prefectural Central Hospital
  • Tokyo, Japan
    • Keio University Hospital
  • Tokyo, Japan
    • Nippon Medical School Hospital
  • Tokyo, Japan
    • Toho University Ohashi Medical Center
  • Tokyo, Japan
    • Juntendo University Hospital
  • Tokyo, Japan
    • Showa University Hospital
  • Tokyo, Japan
    • Teikyo University Hospital
  • Tokyo, Japan
    • Tokyo Medical University Hospital
  • Tokyo, Japan
    • Tokyo Metropolitan Hiroo Hospital
  • Tokyo, Japan
    • Toho University Omori Medical Center
  • Tokyo, Japan
    • Tokyo Women's Medical University Hospital
  • Tokyo, Japan
    • Edogawa Hospital
  • Tokyo, Japan
    • St. Luke's International Hospital
  • Tokyo, Japan
    • Ayase heart hospital
  • Tokyo, Japan
    • Itabashi Chuo Medical Center
  • Tokyo, Japan
    • Jikei University Hospital
  • Tokyo, Japan
    • Juntendo University Nerima Hospital
  • Tokyo, Japan
    • Kanto Medical Center NTT EC
  • Tokyo, Japan
    • Mitsui Memorial Hospital
  • Tokyo, Japan
    • Nihon University School of Medicine Itabashi Hospital
  • Tokyo, Japan
    • The Cardiovascular Institute Hospital
  • Tokyo, Japan
    • Toranomon Hospital
  • Tomishiro, Japan
    • Tomishiro Central Hospital
  • Toyama, Japan
    • Toyama Prefectural Central Hospital
  • Toyama, Japan
    • Toyama Red Cross Hospital
  • Toyoake, Japan
    • Fujita Health University Hospital
  • Toyohashi, Japan
    • Toyohashi Heart Center
  • Tsuchiura, Japan
    • Tsuchiura Kyodo Hospital
  • Tsuyama, Japan
    • Tsuyama Central Hospital
  • Uwajima, Japan
    • Uwajima City Hospital
  • Wakayama, Japan
    • Wakayama Medical University Hospital
  • Yamagata, Japan
    • Yamagata Prefectural Central Hospital
  • Yamaguchi, Japan
    • Saiseikai Yamaguchi Hospital
  • Yatsushiro, Japan
    • Japan Labour Health and Welfare Organization, Kumamoto Rosai hospital
  • Yokohama, Japan
    • Kanagawa Cardiovascular and Respiratory Center
  • Yokohama, Japan
    • Yokohama Sakae Kyosai Hospital
  • Yokohama, Japan
    • Japan Labour Health and Welfare Organization, Yokohama Rosai Hospital
  • 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
  • Yokosuka, Japan
    • Yokosuka General Hospital Uwamachi
  • Yonago, Japan
    • Tottori University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: TAXUS group	Device: TAXUS stent; Compared two kinds of stents:TAXUS stent, approved for commercialization in Japan(March 30th, 2007)
ACTIVE_COMPARATOR: Cypher group	Device: Cypher stent; CYPHER stent, approved for commercialization in Japan(March 25, 2004)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Associations for Establishment of Evidence in Interventions
• Investigators: Study Chair: Shinsuke Nanto, M.D, Non-profit organization(NPO); "Associations for Establishment of Evidence in Intervations"

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: June 30, 2008
• First Submitted That Met QC Criteria: July 1, 2008
• First Posted (ESTIMATE): July 2, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 5, 2014
• Last Update Submitted That Met QC Criteria: November 4, 2014
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: J-DESsERT®, version 1.6