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Status unknownNCT00955214SACRAUpdated Jun 10, 2010

Small Coronary Artery Treated by TAXUS Liberté Registry in Japan

A Phase 4 interventional study of TAXUS Liberté paclitaxel-eluting coronary stent system in Stable Angina Pectoris and Unstable Angina Pectoris, sponsored by Society for Advancement of Coronary Intervention Research. Status unknown at 23 sites in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-06-10.

Sponsored by Society for Advancement of Coronary Intervention Research · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2010), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
250
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stable Angina Pectoris
  • Unstable Angina Pectoris

Keywords

  • TAXUS Liberté
  • Small coronary artery disease
  • Paclitaxel-eluting stent
03

In context

Angina Pectoris

519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.

This study's enrollment of 250 is above the median of 123 across 336 interventional studies indexed under Angina Pectoris.

Browse Angina Pectoris studies →

Lead sponsor

This is the only study on the registry with Society for Advancement of Coronary Intervention Research as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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) -
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    2.5mm Paclitaxel-eluting stent

    Device: TAXUS Liberté paclitaxel-eluting coronary stent system

Interventions

  • DeviceTAXUS Liberté paclitaxel-eluting coronary stent system

    diameter is 2.5mm

06

What researchers measure

Primary outcomes

  1. Target lesion revascularization rate

    Time frame: within 9months

Secondary outcomes

  1. Technical success

    Time frame: initial

  2. Target lesion revascularization rate

    Time frame: 12 months

  3. Target lesion revascularization rate

    Time frame: 24 months

  4. Target vessel revascularization rate

    Time frame: 12 months

  5. Target vessel revascularization rate

    Time frame: 24 months

  6. The rate of MACE including MI due to stent thrombosis

    Time frame: 12 months

  7. The rate of MACE including MI due to stent thrombosis

    Time frame: 24 months

07

Study locations

23 sites
  • Japanese red cross nagoya daiichi hospital
    Nagoya, Aichi 4538511, Japan
  • Higashi Cardiovascular clinic
    Toyohashi, Aichi 4400836, Japan
  • Toyohashi Heart Center
    Toyohashi, Aichi 4418530, Japan
  • Kokura memorial hospital
    Kitakyushu, Fukuoka 8028555, Japan
  • Hoshi general hospital
    Koriyama, Fukushima 9638501, Japan
  • Southen tohoku research institute for neuroscience
    Koriyama, Fukushima 9638563, Japan
  • Gunma prefectural cardiovascular center
    Maebashi, Gunma 3710004, Japan
  • Asahikawa medical college hospital
    Asahikawa, Hokkaido 0788510, Japan
  • Hakodate central general hospital
    Hakodate, Hokkaido, Japan
  • Shinko kakogawa hospital
    Kakogawa, Hyogo 6750115, Japan
  • Okamoto general hospital
    Uji, Kyoto 6110025, Japan
  • Miyagi cardiovascular and respiratory center
    Kurihara, Miyagi 9894513, Japan
  • Rinku general medical center
    Izumiotsu, Osaka 5988577, Japan
  • Shuwa general hospital
    Kasukabe, Saitama 3440035, Japan
  • Kasukabe chuo general hospital
    Kasukabe, Saitama 3440063, Japan
  • Kusatsu Heart Center
    Kusatsu, Shiga 5250014, Japan
  • Ayase heart hospital
    Adachi, Tokyo 1200006, Japan
  • Itabashi Chuo medical center
    Itabashi, Tokyo 1740051, Japan
  • The cardiovascular institute hospital
    Minato, Tokyo 1060032, Japan
  • Tokyo metropolitan police hospital
    Naka, Tokyo 1648541, Japan
  • JR tokyo general hospital
    Shibuya, Tokyo 1518528, Japan
  • Tokyo medical university hospital
    Shinjuku, Tokyo 1600023, Japan
  • Sakurabashi watanabe hospital
    Osaka, 5300001, Japan
08

References and documents

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. PubMed 19463387 ↗
  • 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. PubMed 17359218 ↗
  • 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. PubMed 17010786 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00955214
Lead sponsor
Society for Advancement of Coronary Intervention Research
First posted
Aug 10, 2009
Start date
Apr 2009
Primary completion
Aug 2010 (estimated)
Completion
Aug 2012 (estimated)
Last update
Jun 10, 2010

Study contacts

Kenya Nasu, MD
principal investigator · Toyohashi Heart Center
Yuji Oikawa, MD
principal investigator · Cardiovascular institute hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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