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

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ClinicalTrials.gov Identifier: NCT00955214
Recruitment Status : Unknown
Verified June 2010 by Society for Advancement of Coronary Intervention Research.
Recruitment status was:  Enrolling by invitation
First Posted : August 10, 2009
Last Update Posted : June 10, 2010
Sponsor:
Information provided by:
Society for Advancement of Coronary Intervention Research

August 7, 2009
August 10, 2009
June 10, 2010
April 2009
August 2010   (Final data collection date for primary outcome measure)
Target lesion revascularization rate [ Time Frame: within 9months ]
Same as current
Complete list of historical versions of study NCT00955214 on ClinicalTrials.gov Archive Site
  • Technical success [ Time Frame: initial ]
  • Target lesion revascularization rate [ Time Frame: 12 months ]
  • Target lesion revascularization rate [ Time Frame: 24 months ]
  • Target vessel revascularization rate [ Time Frame: 12 months ]
  • Target vessel revascularization rate [ Time Frame: 24 months ]
  • The rate of MACE including MI due to stent thrombosis [ Time Frame: 12 months ]
  • The rate of MACE including MI due to stent thrombosis [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
 
Small Coronary Artery Treated by TAXUS Liberté Registry in Japan
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Stable Angina Pectoris
  • Unstable Angina Pectoris
Device: TAXUS Liberté paclitaxel-eluting coronary stent system
diameter is 2.5mm
Experimental: 2.5mm Paclitaxel-eluting stent
Intervention: Device: TAXUS Liberté paclitaxel-eluting coronary stent system

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
250
Same as current
August 2012
August 2010   (Final data collection date for primary outcome measure)

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) -
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00955214
SACRA1
Yes
Not Provided
Not Provided
Kenya Nasu, Society for Advancement of Coronary Intervention Research
Society for Advancement of Coronary Intervention Research
Not Provided
Principal Investigator: Kenya Nasu, MD Toyohashi Heart Center
Principal Investigator: Yuji Oikawa, MD Cardiovascular institute hospital
Society for Advancement of Coronary Intervention Research
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP