NCT00708669

Japan-Drug Eluting Stents Evaluation; a Randomized Trial

A Japanese Prospective, Randomized, Multi-center Trial Comparing the TAXUS Stent and the CYPHER Stent in Patients With Coronary Artery Disease Eligible for PCI.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,500 (estimated)
• Sponsor: Associations for Establishment of Evidence in Interventions · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2008-03-01
• Primary completion: 2013-09-01
• First posted: 2008-07-02
• Last updated: 2014-11-05

Locations

122 sites across 1 country: Japan