Small Coronary Artery Treated by TAXUS Liberté Registry in Japan

Stable Angina Pectoris Clinical Trial

— SACRA  

Official title:

Impact of Paclitaxel-eluting Stent for Small Coronary Artery Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00955214
• Other study ID #: SACRA1
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: August 7, 2009
• Last updated: June 9, 2010
• Start date: April 2009
• Est. completion date: August 2012

Study information

• Verified date: June 2010
• Source: Society for Advancement of Coronary Intervention Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: August 2012
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Angina Pectoris
• Unstable Angina Pectoris

Intervention

Device:
• TAXUS Liberté paclitaxel-eluting coronary stent system
diameter is 2.5mm

Locations

Country	Name	City	State
Japan	Ayase heart hospital	Adachi	Tokyo
Japan	Asahikawa medical college hospital	Asahikawa	Hokkaido
Japan	Hakodate central general hospital	Hakodate	Hokkaido
Japan	Itabashi Chuo medical center	Itabashi	Tokyo
Japan	Rinku general medical center	Izumiotsu	Osaka
Japan	Shinko kakogawa hospital	Kakogawa	Hyogo
Japan	Kasukabe chuo general hospital	Kasukabe	Saitama
Japan	Shuwa general hospital	Kasukabe	Saitama
Japan	Kokura memorial hospital	Kitakyushu	Fukuoka
Japan	Hoshi general hospital	Koriyama	Fukushima
Japan	Southen tohoku research institute for neuroscience	Koriyama	Fukushima
Japan	Miyagi cardiovascular and respiratory center	Kurihara	Miyagi
Japan	Kusatsu Heart Center	Kusatsu	Shiga
Japan	Gunma prefectural cardiovascular center	Maebashi	Gunma
Japan	The cardiovascular institute hospital	Minato	Tokyo
Japan	Japanese red cross nagoya daiichi hospital	Nagoya	Aichi
Japan	Tokyo metropolitan police hospital	Naka	Tokyo
Japan	Sakurabashi watanabe hospital	Osaka
Japan	JR tokyo general hospital	Shibuya	Tokyo
Japan	Tokyo medical university hospital	Shinjuku	Tokyo
Japan	Higashi Cardiovascular clinic	Toyohashi	Aichi
Japan	Toyohashi Heart Center	Toyohashi	Aichi
Japan	Okamoto general hospital	Uji	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Society for Advancement of Coronary Intervention Research

Country where clinical trial is conducted

Japan, 

References & Publications (3)

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

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. — View 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 Liberté 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion revascularization rate		within 9months	Yes
Secondary	Technical success		initial	Yes
Secondary	Target lesion revascularization rate		12 months	No
Secondary	Target lesion revascularization rate		24 months	No
Secondary	Target vessel revascularization rate		12 months	No
Secondary	Target vessel revascularization rate		24 months	No
Secondary	The rate of MACE including MI due to stent thrombosis		12 months	Yes
Secondary	The rate of MACE including MI due to stent thrombosis		24 months	Yes