Japan-Drug Eluting Stents Evaluation; a Randomized Trial

Coronary Artery Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708669
• Other study ID #: J-DESsERT®, version 1.6
• Status: Completed
• Phase: N/A
• First received: June 30, 2008
• Last updated: November 4, 2014
• Start date: March 2008

Study information

• Verified date: April 2012
• Source: Associations for Establishment of Evidence in Interventions
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• TAXUS stent
Compared two kinds of stents:TAXUS stent, approved for commercialization in Japan(March 30th, 2007)
• Cypher stent
CYPHER stent, approved for commercialization in Japan(March 25, 2004)

Locations

Country	Name	City	State
Japan	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	Fuchu
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	Higashiomi
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	Kitakyusyu
Japan	Kobe University Hospital	Kobe
Japan	Chikamori Hospital	Kochi
Japan	Hoshi General Hospital	Koriyama
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	Ogaki Municipal Hospital	Ogaki
Japan	Oita Cardiovascular Hospital	Oita
Japan	OitaOka Hospital	Oita
Japan	Okayama Red Cross General Hospital	Okayama
Japan	Okayama University Hospital	Okayama
Japan	Sakakibara Heart Institute of Okayama	Okayama
Japan	Omihachiman Community Medical Center	Omihachiman
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Associations for Establishment of Evidence in Interventions

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Vessel Failure (TVF) at 8 months post-procedure(assessed prior to routine angiography) in Overall study population		8 months	Yes
Secondary	Target Vessel Failure (TVF) at 8 months post-procedure (assessed prior to routine angiography) in diabetic group		8 months	Yes