Small Coronary Artery Treated by TAXUS Liberté Registry in Japan

NCT ID: NCT00955214

Last Updated: 2010-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Stable Angina Pectoris Unstable Angina Pectoris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2.5mm Paclitaxel-eluting stent

Group Type EXPERIMENTAL

TAXUS Liberté paclitaxel-eluting coronary stent system

Intervention Type DEVICE

diameter is 2.5mm

Interventions

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TAXUS Liberté paclitaxel-eluting coronary stent system

diameter is 2.5mm

Intervention Type DEVICE

Eligibility Criteria

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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) -
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society for Advancement of Coronary Intervention Research

NETWORK

Sponsor Role lead

Responsible Party

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Society for Advancement of Coronary Intervention Research

Principal Investigators

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Kenya Nasu, MD

Role: PRINCIPAL_INVESTIGATOR

Toyohashi Heart Center

Yuji Oikawa, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular institute hospital

Locations

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Japanese red cross nagoya daiichi hospital

Nagoya, Aichi-ken, Japan

Site Status

Higashi Cardiovascular clinic

Toyohashi, Aichi-ken, Japan

Site Status

Toyohashi Heart Center

Toyohashi, Aichi-ken, Japan

Site Status

Kokura memorial hospital

Kitakyushu, Fukuoka, Japan

Site Status

Hoshi general hospital

Kōriyama, Fukushima, Japan

Site Status

Southen tohoku research institute for neuroscience

Kōriyama, Fukushima, Japan

Site Status

Gunma prefectural cardiovascular center

Maebashi, Gunma, Japan

Site Status

Asahikawa medical college hospital

Asahikawa, Hokkaido, Japan

Site Status

Hakodate central general hospital

Hakodate, Hokkaido, Japan

Site Status

Shinko kakogawa hospital

Kakogawa, Hyōgo, Japan

Site Status

Okamoto general hospital

Uji, Kyoto, Japan

Site Status

Miyagi cardiovascular and respiratory center

Kurihara, Miyagi, Japan

Site Status

Rinku general medical center

Izumiōtsu, Osaka, Japan

Site Status

Sakurabashi watanabe hospital

Osaka, Osaka, Japan

Site Status

Shuwa general hospital

Kasukabe, Saitama, Japan

Site Status

Kasukabe chuo general hospital

Kasukabe, Saitama, Japan

Site Status

Kusatsu Heart Center

Kusatsu, Shiga, Japan

Site Status

Ayase heart hospital

Adachi City, Tokyo, Japan

Site Status

The cardiovascular institute hospital

Minato, Tokyo, Japan

Site Status

Tokyo metropolitan police hospital

Naka, Tokyo, Japan

Site Status

JR tokyo general hospital

Shibuya City, Tokyo, Japan

Site Status

Tokyo medical university hospital

Shinjuku, Tokyo, Japan

Site Status

Itabashi Chuo medical center

tabashi City, Tokyo, Japan

Site Status

Countries

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Japan

References

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Turco MA, Ormiston JA, Popma JJ, Hall JJ, Mann T, Cannon LA, Webster MW, Mishkel GJ, O'Shaughnessy CD, McGarry TF, Mandinov L, Dawkins KD, Baim DS. Reduced risk of restenosis in small vessels and reduced risk of myocardial infarction in long lesions with the new thin-strut TAXUS Liberte stent: 1-year results from the TAXUS ATLAS program. JACC Cardiovasc Interv. 2008 Dec;1(6):699-709. doi: 10.1016/j.jcin.2008.09.007.

Reference Type BACKGROUND
PMID: 19463387 (View on PubMed)

Ahmed WH. Review of the TAXUS Liberte SR paclitaxel-eluting coronary stent. Expert Rev Med Devices. 2007 Mar;4(2):117-20. doi: 10.1586/17434440.4.2.117.

Reference Type BACKGROUND
PMID: 17359218 (View on PubMed)

Elezi S, Dibra A, Mehilli J, Pache J, Wessely R, Schomig A, Kastrati A. Vessel size and outcome after coronary drug-eluting stent placement: results from a large cohort of patients treated with sirolimus- or paclitaxel-eluting stents. J Am Coll Cardiol. 2006 Oct 3;48(7):1304-9. doi: 10.1016/j.jacc.2006.05.068. Epub 2006 Sep 12.

Reference Type BACKGROUND
PMID: 17010786 (View on PubMed)

Other Identifiers

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SACRA1

Identifier Type: -

Identifier Source: org_study_id

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