Clinical trial NCT00955214: Small Coronary Artery Treated by TAXUS Liberté Registry in Japan
Official title: Impact of Paclitaxel-eluting Stent for Small Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stable Angina Pectoris
Unstable Angina Pectoris
Keywords: TAXUS Liberté
Small coronary artery disease
Paclitaxel-eluting stent
Lead sponsor: Society for Advancement of Coronary Intervention Research
Sponsor class: NETWORK
First posted: 2009-08-10
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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) -

Primary outcomes:
measure: Target lesion revascularization rate
timeFrame: within 9months
Secondary outcomes:
measure: Technical success
timeFrame: initial
measure: Target lesion revascularization rate
timeFrame: 12 months
measure: Target lesion revascularization rate
timeFrame: 24 months
measure: Target vessel revascularization rate
timeFrame: 12 months
measure: Target vessel revascularization rate
timeFrame: 24 months
measure: The rate of MACE including MI due to stent thrombosis
timeFrame: 12 months
measure: The rate of MACE including MI due to stent thrombosis
timeFrame: 24 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Japanese red cross nagoya daiichi hospital
state: Aichi
city: Toyohashi
country: Japan
facility: Higashi Cardiovascular clinic
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Heart Center
state: Aichi
city: Kitakyushu
country: Japan
facility: Kokura memorial hospital
state: Fukuoka
city: Koriyama
country: Japan
facility: Hoshi general hospital
state: Fukushima
city: Koriyama
country: Japan
facility: Southen tohoku research institute for neuroscience
state: Fukushima
city: Maebashi
country: Japan
facility: Gunma prefectural cardiovascular center
state: Gunma
city: Asahikawa
country: Japan
facility: Asahikawa medical college hospital
state: Hokkaido
city: Hakodate
country: Japan
facility: Hakodate central general hospital
state: Hokkaido
city: Kakogawa
country: Japan
facility: Shinko kakogawa hospital
state: Hyogo
city: Uji
country: Japan
facility: Okamoto general hospital
state: Kyoto
city: Kurihara
country: Japan
facility: Miyagi cardiovascular and respiratory center
state: Miyagi
city: Izumiotsu
country: Japan
facility: Rinku general medical center
state: Osaka
city: Kasukabe
country: Japan
facility: Shuwa general hospital
state: Saitama
city: Kasukabe
country: Japan
facility: Kasukabe chuo general hospital
state: Saitama
city: Kusatsu
country: Japan
facility: Kusatsu Heart Center
state: Shiga
city: Adachi
country: Japan
facility: Ayase heart hospital
state: Tokyo
city: Itabashi
country: Japan
facility: Itabashi Chuo medical center
state: Tokyo
city: Minato
country: Japan
facility: The cardiovascular institute hospital
state: Tokyo
city: Naka
country: Japan
facility: Tokyo metropolitan police hospital
state: Tokyo
city: Shibuya
country: Japan
facility: JR tokyo general hospital
state: Tokyo
city: Shinjuku
country: Japan
facility: Tokyo medical university hospital
state: Tokyo
city: Osaka
country: Japan
facility: Sakurabashi watanabe hospital
Study officials:
affiliation: Toyohashi Heart Center
name: Kenya Nasu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular institute hospital
name: Yuji Oikawa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.