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

Impact of Paclitaxel-eluting Stent for Small Coronary Artery Disease

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.

Study Overview

• Status: Unknown
• Conditions: Stable Angina Pectoris; Unstable Angina Pectoris
• Intervention / Treatment: Device: TAXUS Liberté paclitaxel-eluting coronary stent system

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 5300001
    • Sakurabashi Watanabe Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 4538511
      • Japanese Red Cross Nagoya Daiichi Hospital
    • Toyohashi, Aichi, Japan, 4418530
      • Toyohashi Heart Center
    • Toyohashi, Aichi, Japan, 4400836
      • Higashi Cardiovascular clinic
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, ８０２８５５５
      • Kokura Memorial Hospital
  • Fukushima
    • Koriyama, Fukushima, Japan, 9638501
      • Hoshi General Hospital
    • Koriyama, Fukushima, Japan, 9638563
      • Southen tohoku research institute for neuroscience
  • Gunma
    • Maebashi, Gunma, Japan, 3710004
      • Gunma Prefectural Cardiovascular Center
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 0788510
      • Asahikawa Medical College Hospital
    • Hakodate, Hokkaido, Japan
      • Hakodate Central General Hospital
  • Hyogo
    • Kakogawa, Hyogo, Japan, 6750115
      • Shinko kakogawa hospital
  • Kyoto
    • Uji, Kyoto, Japan, 6110025
      • Okamoto general hospital
  • Miyagi
    • Kurihara, Miyagi, Japan, 9894513
      • Miyagi cardiovascular and respiratory center
  • Osaka
    • Izumiotsu, Osaka, Japan, 5988577
      • Rinku General Medical Center
  • Saitama
    • Kasukabe, Saitama, Japan, 3440035
      • Shuwa General Hospital
    • Kasukabe, Saitama, Japan, 3440063
      • Kasukabe Chuo General Hospital
  • Shiga
    • Kusatsu, Shiga, Japan, 5250014
      • Kusatsu Heart Center
  • Tokyo
    • Adachi, Tokyo, Japan, 1200006
      • Ayase heart hospital
    • Itabashi, Tokyo, Japan, 1740051
      • Itabashi Chuo Medical Center
    • Minato, Tokyo, Japan, 1060032
      • The Cardiovascular Institute Hospital
    • Naka, Tokyo, Japan, 1648541
      • Tokyo Metropolitan Police Hospital
    • Shibuya, Tokyo, Japan, 1518528
      • JR Tokyo General Hospital
    • Shinjuku, Tokyo, Japan, 1600023
      • Tokyo Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2.5mm Paclitaxel-eluting stent	Device: TAXUS Liberté paclitaxel-eluting coronary stent system; diameter is 2.5mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target lesion revascularization rate	within 9months

Secondary Outcome Measures

Outcome Measure	Time Frame
Target lesion revascularization rate	12 months
Technical success	initial
Target lesion revascularization rate	24 months
Target vessel revascularization rate	12 months
Target vessel revascularization rate	24 months
The rate of MACE including MI due to stent thrombosis	12 months
The rate of MACE including MI due to stent thrombosis	24 months

Collaborators and Investigators

• Sponsor: Society for Advancement of Coronary Intervention Research
• Investigators: Principal Investigator: Yuji Oikawa, MD, Cardiovascular institute hospital

Publications and helpful links

General 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 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: August 7, 2009
• First Submitted That Met QC Criteria: August 7, 2009
• First Posted (Estimate): August 10, 2009

Study Record Updates

• Last Update Posted (Estimate): June 10, 2010
• Last Update Submitted That Met QC Criteria: June 9, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Paclitaxel-eluting stent; TAXUS Liberté; Small coronary artery disease
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Angina, Unstable; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: SACRA1