Small Coronary Artery Treated by TAXUS Liberté Registry in Japan - Full Text View

Purpose

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.

Condition	Intervention	Phase
Stable Angina Pectoris Unstable Angina Pectoris	Device: TAXUS Liberté paclitaxel-eluting coronary stent system	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Impact of Paclitaxel-eluting Stent for Small Coronary Artery Disease

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Society for Advancement of Coronary Intervention Research:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	250
Study Start Date:	April 2009
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2.5mm Paclitaxel-eluting stent	Device: TAXUS Liberté paclitaxel-eluting coronary stent system diameter is 2.5mm

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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) -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955214

Locations

Japan
Japanese red cross nagoya daiichi hospital
Nagoya, Aichi, Japan, 4538511
Toyohashi Heart Center
Toyohashi, Aichi, Japan, 4418530
Higashi Cardiovascular clinic
Toyohashi, Aichi, Japan, 4400836
Kokura memorial hospital
Kitakyushu, Fukuoka, Japan, 8028555
Hoshi general hospital
Koriyama, Fukushima, Japan, 9638501
Southen tohoku research institute for neuroscience
Koriyama, Fukushima, Japan, 9638563
Gunma prefectural cardiovascular center
Maebashi, Gunma, Japan, 3710004
Asahikawa medical college hospital
Asahikawa, Hokkaido, Japan, 0788510
Hakodate central general hospital
Hakodate, Hokkaido, Japan
Shinko kakogawa hospital
Kakogawa, Hyogo, Japan, 6750115
Okamoto general hospital
Uji, Kyoto, Japan, 6110025
Miyagi cardiovascular and respiratory center
Kurihara, Miyagi, Japan, 9894513
Rinku general medical center
Izumiotsu, Osaka, Japan, 5988577
Shuwa general hospital
Kasukabe, Saitama, Japan, 3440035
Kasukabe chuo general hospital
Kasukabe, Saitama, Japan, 3440063
Kusatsu Heart Center
Kusatsu, Shiga, Japan, 5250014
Ayase heart hospital
Adachi, Tokyo, Japan, 1200006
Itabashi Chuo medical center
Itabashi, Tokyo, Japan, 1740051
The cardiovascular institute hospital
Minato, Tokyo, Japan, 1060032
Tokyo metropolitan police hospital
Naka, Tokyo, Japan, 1648541
JR tokyo general hospital
Shibuya, Tokyo, Japan, 1518528
Tokyo medical university hospital
Shinjuku, Tokyo, Japan, 1600023
Sakurabashi watanabe hospital
Osaka, Japan, 5300001

Sponsors and Collaborators

Society for Advancement of Coronary Intervention Research

Investigators

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

More Information

Publications:

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 Liberté stent: 1-year results from the TAXUS ATLAS program. JACC Cardiovasc Interv. 2008 Dec;1(6):699-709.

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

Elezi S, Dibra A, Mehilli J, Pache J, Wessely R, Schömig 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. Epub 2006 Sep 12.

Responsible Party:	Kenya Nasu, Society for Advancement of Coronary Intervention Research
ClinicalTrials.gov Identifier:	NCT00955214 History of Changes
Other Study ID Numbers:	SACRA1
Study First Received:	August 7, 2009
Last Updated:	June 9, 2010
Health Authority:	Japan: Institutional Review Board

Keywords provided by Society for Advancement of Coronary Intervention Research:

TAXUS Liberté
Small coronary artery disease
Paclitaxel-eluting stent

Additional relevant MeSH terms:

Angina Pectoris
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013

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