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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,500
Compared two kinds of stents:TAXUS stent, approved for commercialization in Japan(March 30th, 2007)
CYPHER stent, approved for commercialization in Japan(March 25, 2004)
Target Vessel Failure (TVF) at 8 months post-procedure(assessed prior to routine angiography) in Overall study population
Time frame: 8 months
Target Vessel Failure (TVF) at 8 months post-procedure (assessed prior to routine angiography) in diabetic group
Time frame: 8 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 112 more locations