Small Coronary Artery Treated by TAXUS Liberté Registry in Japan (SACRA)

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Society for Advancement of Coronary Intervention Research

ClinicalTrials.gov Identifier:

NCT00955214

First received: August 7, 2009

Last updated: June 9, 2010

Last verified: June 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

August 7, 2009

Last Updated Date

June 9, 2010

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Target lesion revascularization rate [ Time Frame: within 9months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00955214 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Technical success [ Time Frame: initial ] [ Designated as safety issue: Yes ]
Target lesion revascularization rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Target lesion revascularization rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Target vessel revascularization rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Target vessel revascularization rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
The rate of MACE including MI due to stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
The rate of MACE including MI due to stent thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Small Coronary Artery Treated by TAXUS Liberté Registry in Japan

Official Title ^ICMJE

Impact of Paclitaxel-eluting Stent for Small Coronary Artery Disease

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Stable Angina Pectoris
Unstable Angina Pectoris

Intervention ^ICMJE

Device: TAXUS Liberté paclitaxel-eluting coronary stent system

diameter is 2.5mm

Study Arm (s)

Experimental: 2.5mm Paclitaxel-eluting stent

Intervention: Device: TAXUS Liberté paclitaxel-eluting coronary stent system

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Enrollment ^ICMJE

250

Estimated Completion Date

August 2012

Estimated Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00955214

Other Study ID Numbers ^ICMJE

SACRA1

Has Data Monitoring Committee

Yes

Responsible Party

Kenya Nasu, Society for Advancement of Coronary Intervention Research

Study Sponsor ^ICMJE

Society for Advancement of Coronary Intervention Research

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Kenya Nasu, MD	Toyohashi Heart Center
Principal Investigator:	Yuji Oikawa, MD	Cardiovascular institute hospital

Information Provided By

Society for Advancement of Coronary Intervention Research

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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