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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Society for Advancement of Coronary Intervention Research
ClinicalTrials.gov Identifier:
NCT00955214
First received: August 7, 2009
Last updated: June 9, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Stable Angina Pectoris
Unstable Angina Pectoris
Device: TAXUS Liberté paclitaxel-eluting coronary stent system
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Paclitaxel-eluting Stent for Small Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Society for Advancement of Coronary Intervention Research:

Primary Outcome Measures:
  • Target lesion revascularization rate [ Time Frame: within 9months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Technical success [ Time Frame: initial ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Target vessel revascularization rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Target vessel revascularization rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • The rate of MACE including MI due to stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The rate of MACE including MI due to stent thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 250
Study Start Date: April 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2.5mm Paclitaxel-eluting stent Device: TAXUS Liberté paclitaxel-eluting coronary stent system
diameter is 2.5mm

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955214

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

Publications:
Responsible Party: Kenya Nasu, Society for Advancement of Coronary Intervention Research
ClinicalTrials.gov Identifier: NCT00955214     History of Changes
Other Study ID Numbers: SACRA1
Study First Received: August 7, 2009
Last Updated: June 9, 2010
Health Authority: Japan: Institutional Review Board

Keywords provided by Society for Advancement of Coronary Intervention Research:
TAXUS Liberté
Small coronary artery disease
Paclitaxel-eluting stent

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014