Small Coronary Artery Treated by TAXUS Liberté Registry in Japan

Phase 4

• Conditions: Stable Angina Pectoris; Unstable Angina Pectoris
• Interventions: Device: TAXUS Liberté paclitaxel-eluting coronary stent system

• Registration Number: NCT00955214
• Lead Sponsor: Society for Advancement of Coronary Intervention Research

Brief Summary

The utilization of paclitaxel-eluting coronary stents in small vessel diseases is effective in reducing both repeat revascularization and major adverse cardiac events within two year follow-up. To evaluate the procedural, short and long term clinical outcomes of the Taxus Liberte™ Paclitaxel-Eluting Coronary Stent in small coronary arteries of ≤ 2.5 mm in the reference vessel diameter.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-09
• Last Update Posted: 2010-06-10
• Primary Completion: 2010-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Age ≥20 years and are able to undergo CABG
2. Females who are not pregnant
3. Patients who present with angina symptoms or myocardial ischemia
4. Patients available for post-procedural observation and coronary angiography at 24 months
5. Patients who have signed patient informed consent
6. Lesion which is eligible for only one 2.5mm paclitaxel-eluting stent
7. De novo lesion or non-stented restenosed lesion

Exclusion Criteria

1. Patients contraindicated for antiplatelet therapy or anticoagulant therapy
2. Patients with significant allergic reaction to contrast medium
3. Chronic total occlusion
4. Lesion with TIMI0
5. Lesion which is needed more than two stents
6. Patients with chronic renal failure (SCr>3.0mg/dl) -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2.5mm Paclitaxel-eluting stent	TAXUS Liberté paclitaxel-eluting coronary stent system	-

Primary Outcome Measures

Name	Time	Method
Target lesion revascularization rate	within 9months

Secondary Outcome Measures

Name	Time	Method
Technical success	initial
Target lesion revascularization rate	24 months
Target vessel revascularization rate	24 months
The rate of MACE including MI due to stent thrombosis	24 months

Trial Locations

Locations (23)

Tokyo metropolitan police hospital; 🇯🇵 Naka, Tokyo, Japan

Higashi Cardiovascular clinic; 🇯🇵 Toyohashi, Aichi, Japan

Japanese red cross nagoya daiichi hospital; 🇯🇵 Nagoya, Aichi, Japan

Sakurabashi watanabe hospital; 🇯🇵 Osaka, Japan

Hoshi general hospital; 🇯🇵 Koriyama, Fukushima, Japan

Tokyo medical university hospital; 🇯🇵 Shinjuku, Tokyo, Japan

Kokura memorial hospital; 🇯🇵 Kitakyushu, Fukuoka, Japan

Southen tohoku research institute for neuroscience; 🇯🇵 Koriyama, Fukushima, Japan

Toyohashi Heart Center; 🇯🇵 Toyohashi, Aichi, Japan

Hakodate central general hospital; 🇯🇵 Hakodate, Hokkaido, Japan

Asahikawa medical college hospital; 🇯🇵 Asahikawa, Hokkaido, Japan

Shinko kakogawa hospital; 🇯🇵 Kakogawa, Hyogo, Japan

Gunma prefectural cardiovascular center; 🇯🇵 Maebashi, Gunma, Japan

Ayase heart hospital; 🇯🇵 Adachi, Tokyo, Japan

Rinku general medical center; 🇯🇵 Izumiotsu, Osaka, Japan

Okamoto general hospital; 🇯🇵 Uji, Kyoto, Japan

Kasukabe chuo general hospital; 🇯🇵 Kasukabe, Saitama, Japan

Miyagi cardiovascular and respiratory center; 🇯🇵 Kurihara, Miyagi, Japan

Shuwa general hospital; 🇯🇵 Kasukabe, Saitama, Japan

Itabashi Chuo medical center; 🇯🇵 Itabashi, Tokyo, Japan

The cardiovascular institute hospital; 🇯🇵 Minato, Tokyo, Japan

JR tokyo general hospital; 🇯🇵 Shibuya, Tokyo, Japan

Kusatsu Heart Center; 🇯🇵 Kusatsu, Shiga, Japan