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Stable Angina PectorisPhase 4SACRANCT00955214

Small Coronary Artery Treated by TAXUS Liberté Registry in Japan

A Phase 4 study testing TAXUS Liberté paclitaxel-eluting coronary stent system in people with Stable Angina Pectoris and Unstable Angina Pectoris, run by Society for Advancement of Coronary Intervention Research at 23 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
TAXUS Liberté paclitaxel-eluting coronary stent system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
23 sitesJapan
Study dates
Apr 2009to Aug 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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) -

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Japan23 sites

  • Ayase heart hospital

    Adachi City, Tokyo, 1200006

  • Asahikawa medical college hospital

    Asahikawa, Hokkaido, 0788510

  • Hakodate central general hospital

    Hakodate, Hokkaido

  • Rinku general medical center

    Izumiōtsu, Osaka, 5988577

  • Shinko kakogawa hospital

    Kakogawa, Hyōgo, 6750115

  • Shuwa general hospital

    Kasukabe, Saitama, 3440035

  • Kasukabe chuo general hospital

    Kasukabe, Saitama, 3440063

  • Kokura memorial hospital

    Kitakyushu, Fukuoka, 8028555

  • Hoshi general hospital

    Kōriyama, Fukushima, 9638501

  • Southen tohoku research institute for neuroscience

    Kōriyama, Fukushima, 9638563

  • Miyagi cardiovascular and respiratory center

    Kurihara, Miyagi, 9894513

  • Kusatsu Heart Center

    Kusatsu, Shiga, 5250014

  • Gunma prefectural cardiovascular center

    Maebashi, Gunma, 3710004

  • The cardiovascular institute hospital

    Minato, Tokyo, 1060032

  • Japanese red cross nagoya daiichi hospital

    Nagoya, Aichi-ken, 4538511

  • Tokyo metropolitan police hospital

    Naka, Tokyo, 1648541

  • Sakurabashi watanabe hospital

    Osaka, Osaka, 5300001

  • JR tokyo general hospital

    Shibuya City, Tokyo, 1518528

  • Tokyo medical university hospital

    Shinjuku, Tokyo, 1600023

  • Itabashi Chuo medical center

    tabashi City, Tokyo, 1740051

  • Higashi Cardiovascular clinic

    Toyohashi, Aichi-ken, 4400836

  • Toyohashi Heart Center

    Toyohashi, Aichi-ken, 4418530

  • Okamoto general hospital

    Uji, Kyoto, 6110025

Other trials in Japan

About this study

Official title: 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.

Being tested
TAXUS Liberté paclitaxel-eluting coronary stent system
Keywords
TAXUS Liberté, Small coronary artery disease, Paclitaxel-eluting stent
Medical subject headings
Angina, Stable, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAXUS Liberté paclitaxel-eluting coronary stent systemDevice

    diameter is 2.5mm

Study groups in NCT00955214
Study groupRoleWhat they receive
2.5mm Paclitaxel-eluting stentExperimentalNot described
Receives: Device: TAXUS Liberté paclitaxel-eluting coronary stent system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target lesion revascularization rate

    Measured: within 9months

Secondary outcomes (7)

  1. Technical success

    Measured: initial

  2. Target lesion revascularization rate

    Measured: 12 months

  3. Target lesion revascularization rate

    Measured: 24 months

  4. Target vessel revascularization rate

    Measured: 12 months

  5. Target vessel revascularization rate

    Measured: 24 months

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

    Measured: 12 months

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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionAug 2010 (estimated)
  4. Study completionAug 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00955214
Sponsor's protocol ID
SACRA1
Acronym
SACRA
Status last verified
Jun 2010
First submitted
7 Aug 2009
Last updated
10 Jun 2010
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TAXUS Liberté paclitaxel-eluting coronary stent system in people with Stable Angina Pectoris and Unstable Angina Pectoris, run by Society for Advancement of Coronary Intervention Research at 23 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesion revascularization rate (time frame: within 9months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00955214, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2010.

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