Coronary Artery DiseaseJ-DESsERT®NCT00708669
Japan-Drug Eluting Stents Evaluation; a Randomized Trial
A study testing TAXUS stent and Cypher stent in people with Coronary Artery Disease, run by Associations for Establishment of Evidence in Interventions at 122 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- TAXUS stent and Cypher stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 122 sitesJapan
- Study dates
- Mar 2008to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
122 sites in 1 country.
122 sites in 1 country
Japan122 sites
Aichi Medical University Hospital
Aichi
Japan Labour Health and Welfare Organization, Kansai Rosai Hospital
Amagasaki
Asahikawa-Kosei General Hospital
Asahikawa
Sakakibara Memorial Hospital
Fuchū
Fukui Cardiovascular Center
Fukui
Fukuoka University Hospital
Fukuoka
Gifu Prefectural General Medical Center
Gifu
Seirei Hamamatsu General Hospital
Hamamatsu
Hekinan Municipal Hospital
Hekinan
Saitama Medical University International Medical Center
Hidaka
Koto Memorial Hospital
Higashiōmi
Kansai Medical University Hirakata Hospital
Hirakata
Hiratsuka Kyosai Hospital
Hiratsuka
Hirosaki University School of Medicine and Hospital
Hirosaki
Hiroshima University Hospital
Hiroshima
Tsuchiya General Hospital
Hiroshima
Iizuka Hospital
Iizuka
Saiseikai Imabari Hospital
Imabari
Nippon Medical School Chiba Hokusoh Hospital
Inzai
Iwaki Kyoritsu Hospital
Iwaki
Rinku General Medical Center
Izumisano
Juntendo University Shizuoka Hospital
Izunokuni
Setsunan General Hospital
Kadoma
Ishikawa Prefectural Central Hospital
Kanazawa
Kanazawa Cardiovascular Hospital
Kanazawa
Nara Medical University Hospital
Kashihara
Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
Kawasaki
Kawasaki Saiwai Hospital
Kawasaki
Kagawa University Hospital
Kida
Kimitsu Chuo Hospital
Kisarazu
Kokura Memorial Hospital
Kitakyushu
Kobe University Hospital
Kobe
Chikamori Hospital
Kochi
Hoshi General Hospital
Kōriyama
Kumamoto Chuo Hospital
Kumamoto
Saiseikai Kumamoto Hospital
Kumamoto
Kawasaki Medical School Hospital
Kurashiki
Kurume University Hospital
Kurume
St.Mary's Hospital
Kurume
Japanese Red Cross Kyoto Daini Hospital
Kyoto
Koseikai Takeda Hospital
Kyoto
Kyoto-Katsura Hospital
Kyoto
Mie Heart Center
Mie
Miki City Hospital
Miki
Miyazaki Medical Association Hospital
Miyazaki
Memorial Heart Center Iwate Medical University
Morioka
Shiga Medical Center for Adults
Moriyama
Musashino Red Cross Hospital
Musashino
Tachikawa General Hospital
Nagaoka
Kouseikai Hospital
Nagasaki
Nagoya daiichi red cross Hospital
Nagoya
Nagoya Daini Red Cross Hospital
Nagoya
Nagoya Memorial Hospital
Nagoya
Ogaki Municipal Hospital
Ōgaki
Oita Cardiovascular Hospital
Ōita
OitaOka Hospital
Ōita
Okayama Red Cross General Hospital
Okayama
Okayama University Hospital
Okayama
Sakakibara Heart Institute of Okayama
Okayama
Omihachiman Community Medical Center
Ōmihachiman
National Hospital Organization Osaka National Hospital
Osaka
Osaka City University Hospital
Osaka
Osaka General Medical Center
Osaka
Osaka Police Hospital
Osaka
Kitasato University Hospital
Sagamihara
Iwatsuki-minami Hospital
Saitama
Japan Labour Health and Welfare Organization, Osaka Rosai Hospital
Sakai
Caress Sapporo Hokko Memorial Hospital
Sapporo
Caress Sapporo Tokeidai Hospital
Sapporo
Hokkaido Social Insurance Hospital
Sapporo
Sapporo Orthopaedic Cardio-vascular Hospital
Sapporo
Teine Keijinkai Hospital
Sapporo
Sendai Kousei Hospital
Sendai
Sendai Open Hospital
Sendai
Tohoku Koseinenkin Hospital
Sendai
Jichi Medical University Hospital
Shimotsuke
National Cerebral and Cardiovascular Center
Suita
Osaka University Graduate School of Medicine
Suita
Kagawa Prefectural Central Hospital
Takamatsu
Ayase Heart Hospital
Tokyo
Edogawa Hospital
Tokyo
Itabashi Chuo Medical Center
Tokyo
Jikei University Hospital
Tokyo
Juntendo University Hospital
Tokyo
Juntendo University Nerima Hospital
Tokyo
Kanto Medical Center NTT EC
Tokyo
Keio University Hospital
Tokyo
Mitsui Memorial Hospital
Tokyo
Nihon University School of Medicine Itabashi Hospital
Tokyo
Nippon Medical School Hospital
Tokyo
Showa University Hospital
Tokyo
St. Luke's International Hospital
Tokyo
Teikyo University Hospital
Tokyo
The Cardiovascular Institute Hospital
Tokyo
Toho University Ohashi Medical Center
Tokyo
Toho University Omori Medical Center
Tokyo
Tokyo Medical University Hospital
Tokyo
Tokyo Metropolitan Hiroo Hospital
Tokyo
Tokyo Women's Medical University Hospital
Tokyo
Toranomon Hospital
Tokyo
Tomishiro Central Hospital
Tomishiro
Toyama Prefectural Central Hospital
Toyama
Toyama Red Cross Hospital
Toyama
Fujita Health University Hospital
Toyoake
Toyohashi Heart Center
Toyohashi
Tsuchiura Kyodo Hospital
Tsuchiura
Tsuyama Central Hospital
Tsuyama
Uwajima City Hospital
Uwajima
Wakayama Medical University Hospital
Wakayama
Yamagata Prefectural Central Hospital
Yamagata
Saiseikai Yamaguchi Hospital
Yamaguchi
Japan Labour Health and Welfare Organization, Kumamoto Rosai hospital
Yatsushiro
Japan Labour Health and Welfare Organization, Yokohama Rosai Hospital
Yokohama
Kanagawa Cardiovascular and Respiratory Center
Yokohama
Kikuna Memorial Hospital
Yokohama
Saiseikai Yokohamashi Tobu Hospital
Yokohama
Showa University Fujigaoka Hospital
Yokohama
Showa University Northern Yokohama Hospital
Yokohama
Yokohama City University General Medical Center
Yokohama
Yokohama Sakae Kyosai Hospital
Yokohama
Yokosuka General Hospital Uwamachi
Yokosuka
Tottori University Hospital
Yonago
About this study
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.
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.
Read the 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
- Being tested
- TAXUS stent, Cypher stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAXUS stentDevice
Compared two kinds of stents:TAXUS stent, approved for commercialization in Japan(March 30th, 2007)
Cypher stentDevice
CYPHER stent, approved for commercialization in Japan(March 25, 2004)
| Study group | Role | What they receive |
|---|---|---|
| TAXUS group | Active comparator | Not described Receives: Device: TAXUS stent |
| Cypher group | Active comparator | Not described Receives: Device: Cypher stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure (TVF) at 8 months post-procedure(assessed prior to routine angiography) in Overall study population
Measured: 8 months
Secondary outcomes (1)
Target Vessel Failure (TVF) at 8 months post-procedure (assessed prior to routine angiography) in diabetic group
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associations for Establishment of Evidence in Interventions
- Sponsor type
- University, hospital or other
- Investigators
- Shinsuke Nanto, M.D, Study chair, Non-profit organization(NPO); "Associations for Establishment of Evidence in Intervations"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708669
- Sponsor's protocol ID
- J-DESsERT®, version 1.6
- Acronym
- J-DESsERT®
- Status last verified
- Apr 2012
- First submitted
- 30 Jun 2008
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00708669
- Acronym / sponsor ID
- J-DESsERT® / J-DESsERT®, version 1.6
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Associations for Establishment of Evidence in InterventionsUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2013 (actual)
- First posted
- 2 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAXUS group | Active comparator | Device: TAXUS stent |
| Cypher group | Active comparator | Device: Cypher stent |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAXUS stentCompared two kinds of stents:TAXUS stent, approved for commercialization in Japan(March 30th, 2007) | Device | TAXUS group |
| Cypher stentCYPHER stent, approved for commercialization in Japan(March 25, 2004) | Device | Cypher group |
Primary outcome
Target Vessel Failure (TVF) at 8 months post-procedure(assessed prior to routine angiography) in Overall study population
Time frame: 8 months
1 secondary outcome
Target Vessel Failure (TVF) at 8 months post-procedure (assessed prior to routine angiography) in diabetic group
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shinsuke Nanto, M.D study chair
Non-profit organization(NPO); "Associations for Establishment of Evidence in Intervations"
122 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAXUS stent and Cypher stent in people with Coronary Artery Disease, run by Associations for Establishment of Evidence in Interventions at 122 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 122 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Vessel Failure (TVF) at 8 months post-procedure(assessed prior to routine angiography) in Overall study population (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014; AzTrials last refreshed its copy on 3 Nov 2026.