Japan-Drug Eluting Stents Evaluation; a Randomized Trial

NCT ID: NCT00708669

Last Updated: 2014-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAXUS group

Group Type: ACTIVE_COMPARATOR

TAXUS stent

Intervention Type: DEVICE

Compared two kinds of stents:TAXUS stent, approved for commercialization in Japan(March 30th, 2007)

Cypher group

Group Type: ACTIVE_COMPARATOR

Cypher stent

Intervention Type: DEVICE

CYPHER stent, approved for commercialization in Japan(March 25, 2004)

Interventions

TAXUS stent

Compared two kinds of stents:TAXUS stent, approved for commercialization in Japan(March 30th, 2007)

Intervention Type: DEVICE

Cypher stent

CYPHER stent, approved for commercialization in Japan(March 25, 2004)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associations for Establishment of Evidence in Interventions

OTHER

Sponsor Role: lead

Responsible Party

Associations for Establishment of Evidence in Interventions

Principal Investigators

Shinsuke Nanto, M.D

Role: STUDY_CHAIR

Non-profit organization(NPO); "Associations for Establishment of Evidence in Intervations"

Locations

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

Countries

Japan

Other Identifiers

J-DESsERT®, version 1.6

Identifier Type: -

Identifier Source: org_study_id