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

Primary Purpose

Stable Angina Pectoris, Unstable Angina Pectoris

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
TAXUS Liberté paclitaxel-eluting coronary stent system
Sponsored by
Society for Advancement of Coronary Intervention Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina Pectoris focused on measuring TAXUS Liberté, Small coronary artery disease, Paclitaxel-eluting stent

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) -

Sites / Locations

  • Japanese red cross nagoya daiichi hospital
  • Higashi Cardiovascular clinic
  • Toyohashi Heart Center
  • Kokura memorial hospital
  • Hoshi general hospital
  • Southen tohoku research institute for neuroscience
  • Gunma prefectural cardiovascular center
  • Asahikawa medical college hospital
  • Hakodate central general hospital
  • Shinko kakogawa hospital
  • Okamoto general hospital
  • Miyagi cardiovascular and respiratory center
  • Rinku general medical center
  • Shuwa general hospital
  • Kasukabe chuo general hospital
  • Kusatsu Heart Center
  • Ayase heart hospital
  • Itabashi Chuo medical center
  • The cardiovascular institute hospital
  • Tokyo metropolitan police hospital
  • JR tokyo general hospital
  • Tokyo medical university hospital
  • Sakurabashi watanabe hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

2.5mm Paclitaxel-eluting stent

Arm Description

Outcomes

Primary Outcome Measures

Target lesion revascularization rate

Secondary Outcome Measures

Technical success
Target lesion revascularization rate
Target lesion revascularization rate
Target vessel revascularization rate
Target vessel revascularization rate
The rate of MACE including MI due to stent thrombosis
The rate of MACE including MI due to stent thrombosis

Full Information

First Posted
August 7, 2009
Last Updated
June 9, 2010
Sponsor
Society for Advancement of Coronary Intervention Research
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1. Study Identification

Unique Protocol Identification Number
NCT00955214
Brief Title
Small Coronary Artery Treated by TAXUS Liberté Registry in Japan
Acronym
SACRA
Official Title
Impact of Paclitaxel-eluting Stent for Small Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Society for Advancement of Coronary Intervention Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina Pectoris, Unstable Angina Pectoris
Keywords
TAXUS Liberté, Small coronary artery disease, Paclitaxel-eluting stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2.5mm Paclitaxel-eluting stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TAXUS Liberté paclitaxel-eluting coronary stent system
Intervention Description
diameter is 2.5mm
Primary Outcome Measure Information:
Title
Target lesion revascularization rate
Time Frame
within 9months
Secondary Outcome Measure Information:
Title
Technical success
Time Frame
initial
Title
Target lesion revascularization rate
Time Frame
12 months
Title
Target lesion revascularization rate
Time Frame
24 months
Title
Target vessel revascularization rate
Time Frame
12 months
Title
Target vessel revascularization rate
Time Frame
24 months
Title
The rate of MACE including MI due to stent thrombosis
Time Frame
12 months
Title
The rate of MACE including MI due to stent thrombosis
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥20 years and are able to undergo CABG Females who are not pregnant Patients who present with angina symptoms or myocardial ischemia Patients available for post-procedural observation and coronary angiography at 24 months Patients who have signed patient informed consent Lesion which is eligible for only one 2.5mm paclitaxel-eluting stent De novo lesion or non-stented restenosed lesion Exclusion Criteria: Patients contraindicated for antiplatelet therapy or anticoagulant therapy Patients with significant allergic reaction to contrast medium Chronic total occlusion Lesion with TIMI0 Lesion which is needed more than two stents Patients with chronic renal failure (SCr>3.0mg/dl) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenya Nasu, MD
Organizational Affiliation
Toyohashi Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuji Oikawa, MD
Organizational Affiliation
Cardiovascular institute hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Japanese red cross nagoya daiichi hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4538511
Country
Japan
Facility Name
Higashi Cardiovascular clinic
City
Toyohashi
State/Province
Aichi
ZIP/Postal Code
4400836
Country
Japan
Facility Name
Toyohashi Heart Center
City
Toyohashi
State/Province
Aichi
ZIP/Postal Code
4418530
Country
Japan
Facility Name
Kokura memorial hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
8028555
Country
Japan
Facility Name
Hoshi general hospital
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
9638501
Country
Japan
Facility Name
Southen tohoku research institute for neuroscience
City
Koriyama
State/Province
Fukushima
ZIP/Postal Code
9638563
Country
Japan
Facility Name
Gunma prefectural cardiovascular center
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
3710004
Country
Japan
Facility Name
Asahikawa medical college hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
0788510
Country
Japan
Facility Name
Hakodate central general hospital
City
Hakodate
State/Province
Hokkaido
Country
Japan
Facility Name
Shinko kakogawa hospital
City
Kakogawa
State/Province
Hyogo
ZIP/Postal Code
6750115
Country
Japan
Facility Name
Okamoto general hospital
City
Uji
State/Province
Kyoto
ZIP/Postal Code
6110025
Country
Japan
Facility Name
Miyagi cardiovascular and respiratory center
City
Kurihara
State/Province
Miyagi
ZIP/Postal Code
9894513
Country
Japan
Facility Name
Rinku general medical center
City
Izumiotsu
State/Province
Osaka
ZIP/Postal Code
5988577
Country
Japan
Facility Name
Shuwa general hospital
City
Kasukabe
State/Province
Saitama
ZIP/Postal Code
3440035
Country
Japan
Facility Name
Kasukabe chuo general hospital
City
Kasukabe
State/Province
Saitama
ZIP/Postal Code
3440063
Country
Japan
Facility Name
Kusatsu Heart Center
City
Kusatsu
State/Province
Shiga
ZIP/Postal Code
5250014
Country
Japan
Facility Name
Ayase heart hospital
City
Adachi
State/Province
Tokyo
ZIP/Postal Code
1200006
Country
Japan
Facility Name
Itabashi Chuo medical center
City
Itabashi
State/Province
Tokyo
ZIP/Postal Code
1740051
Country
Japan
Facility Name
The cardiovascular institute hospital
City
Minato
State/Province
Tokyo
ZIP/Postal Code
1060032
Country
Japan
Facility Name
Tokyo metropolitan police hospital
City
Naka
State/Province
Tokyo
ZIP/Postal Code
1648541
Country
Japan
Facility Name
JR tokyo general hospital
City
Shibuya
State/Province
Tokyo
ZIP/Postal Code
1518528
Country
Japan
Facility Name
Tokyo medical university hospital
City
Shinjuku
State/Province
Tokyo
ZIP/Postal Code
1600023
Country
Japan
Facility Name
Sakurabashi watanabe hospital
City
Osaka
ZIP/Postal Code
5300001
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19463387
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 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.
Results Reference
background
PubMed Identifier
17359218
Citation
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.
Results Reference
background
PubMed Identifier
17010786
Citation
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.
Results Reference
background

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Small Coronary Artery Treated by TAXUS Liberté Registry in Japan

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