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AzTrials

Coronary Artery DiseasePhase 4OCTAXUSNCT00704145

Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease

A Phase 4 study testing Taxus Libertè™ paclitaxel drug-eluting stent in people with Coronary Artery Disease, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A prospective Optical Coherence Tomography (OCT) study on the completeness of strut coverage and vessel wall response, at different time points (3-6-9 Months), following TAXUS Liberte stent implantation (staged procedures) in patients with multi vessel native coronary artery lesions Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Taxus Libertè™ paclitaxel drug-eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
Nov 2007to Nov 2009
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Multivessel coronary artery disease (two or 3 VD) to be treated at 2 sequences (staged procedures) with paclitaxel-polymer eluting stents
  • Native coronary artery disease with >= 75% diameter stenosis
  • Vessel size in between 2.5 and 3.5 mm.
  • Written informed consent signed

Who cannot join

  • No suitable anatomy for OCT scan: (truly ostial , tortuous anatomy, very distal lesions or vessels larger than 3.75 in reference diameter).
  • significant left main coronary artery disease,
  • lesions in bypass grafts,
  • acute myocardial infarction,
  • poor cardiac function as defined by left ventricular ejection fraction ≤ 30%.
  • allergy to aspirin and or clopidogrel/ticlopidine,
  • Renal failure with creatinine value > 2.5 mg/dl

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ospedali Riuniti di Bergamo

    Bergamo, 24100

Other trials in Italy

About this study

Official title: A Prospective Optical Coherence Tomography Study on Completeness of Strut Coverage and Vessel Wall Response at 3-6 and 9 Months Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease

A prospective Optical Coherence Tomography (OCT) study on the completeness of strut coverage and vessel wall response, at different time points (3-6-9 Months), following TAXUS Liberte stent implantation (staged procedures) in patients with multi vessel native coronary artery lesions

Read the detailed description

Major concerns were addressed to the delayed healing process of drug-eluting stents in off-label indications. To date no studies have detailed the in-vivo completeness of DES coverage at different time points. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response (neointima disomogeneity, acquired late incomplete strut apposition) at different time points following paclitaxel-eluting stent implantation, in patients with multivessel disease treated with staged PCI procedures. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at different time point. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and 9 months elective follow-up.

Being tested
Taxus Libertè™ paclitaxel drug-eluting stent
Keywords
Drug Eluting Stents, Percutaneous Coronary Interventions, Optical Coherence Tomography
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Taxus Libertè™ paclitaxel drug-eluting stentDevice

    Also called Taxus Libertè™ (Boston Scientific,Natick,MS)

    device:Taxus Libertè™ (Boston Scientific,Natick,MS)assessed at different time points after implant

Study groups in NCT00704145
Study groupRoleWhat they receive
AExperimentalDevice, paclitaxel drug-eluting stent
Receives: Device: Taxus Libertè™ paclitaxel drug-eluting stent

What is being measured

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

  1. Proportion of uncovered and/or malapposed Taxus Libertè struts at different time point after the implant, as measured by OCT

    Measured: 3-6-9 months

Secondary outcomes (5)

  1. % Incomplete apposition at different point of FU (3-6-9 months)

    Measured: 3-6-9 months

  2. Proportion of neointima disomogeneity around struts at different point of FU (3-6-9 months)

    Measured: 3-6-9 months

  3. OCT Neointima thickness overtime

    Measured: 3-6-9 months

  4. Ischemia Driven Target Vessel Failure (ID-TVF) rate at 12 months

    Measured: 12 months

  5. Adjudicated MACE rate at 30 days and 12 months

    Measured: 30 days and 12 months

Timeline

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

  1. First posted24 Jun 2008 (estimated)
  2. Study startNov 2007
  3. Primary completionAug 2009
  4. Study completionNov 2009

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00704145
Sponsor's protocol ID
1087/2007
Acronym
OCTAXUS
Status last verified
Feb 2010
First submitted
20 Jun 2008
Last updated
9 Feb 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, Virmani R. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol. 2007 Jul;27(7):1500-10. doi: 10.1161/ATVBAHA.107.144220. Epub 2007 May 17.

    PubMed 17510464

  • Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.

    PubMed 17438147

  • Park DW, Yun SC, Lee SW, Kim YH, Lee CW, Hong MK, Kim JJ, Choo SJ, Song H, Chung CH, Lee JW, Park SW, Park SJ. Long-term mortality after percutaneous coronary intervention with drug-eluting stent implantation versus coronary artery bypass surgery for the treatment of multivessel coronary artery disease. Circulation. 2008 Apr 22;117(16):2079-86. doi: 10.1161/CIRCULATIONAHA.107.750109. Epub 2008 Apr 14.

    PubMed 18413495

  • Briguori C, Colombo A, Airoldi F, Focaccio A, Iakovou I, Chieffo A, Michev I, Montorfano M, Bonizzoni E, Ricciardelli B, Condorelli G. Sirolimus-eluting stent implantation in diabetic patients with multivessel coronary artery disease. Am Heart J. 2005 Oct;150(4):807-13. doi: 10.1016/j.ahj.2004.12.012.

    PubMed 16209986

  • Rodriguez AE, Mieres J, Fernandez-Pereira C, Vigo CF, Rodriguez-Alemparte M, Berrocal D, Grinfeld L, Palacios I. Coronary stent thrombosis in the current drug-eluting stent era: insights from the ERACI III trial. J Am Coll Cardiol. 2006 Jan 3;47(1):205-7. doi: 10.1016/j.jacc.2005.10.016. Epub 2005 Dec 9. No abstract available.

    PubMed 16386687

  • Matsumoto D, Shite J, Shinke T, Otake H, Tanino Y, Ogasawara D, Sawada T, Paredes OL, Hirata K, Yokoyama M. Neointimal coverage of sirolimus-eluting stents at 6-month follow-up: evaluated by optical coherence tomography. Eur Heart J. 2007 Apr;28(8):961-7. doi: 10.1093/eurheartj/ehl413. Epub 2006 Nov 29.

    PubMed 17135281

  • Takano M, Inami S, Jang IK, Yamamoto M, Murakami D, Seimiya K, Ohba T, Mizuno K. Evaluation by optical coherence tomography of neointimal coverage of sirolimus-eluting stent three months after implantation. Am J Cardiol. 2007 Apr 15;99(8):1033-8. doi: 10.1016/j.amjcard.2006.11.068. Epub 2007 Feb 23.

    PubMed 17437723

  • Yamaguchi T, Terashima M, Akasaka T, Hayashi T, Mizuno K, Muramatsu T, Nakamura M, Nakamura S, Saito S, Takano M, Takayama T, Yoshikawa J, Suzuki T. Safety and feasibility of an intravascular optical coherence tomography image wire system in the clinical setting. Am J Cardiol. 2008 Mar 1;101(5):562-7. doi: 10.1016/j.amjcard.2007.09.116. Epub 2008 Jan 10.

    PubMed 18307999

  • Guagliumi G, Bezerra HG, Sirbu V, Ikejima H, Musumeci G, Biondi-Zoccai G, Lortkipanidze N, Fiocca L, Capodanno D, Wang W, Tahara S, Vassileva A, Matiashvili A, Valsecchi O, Costa MA. Serial assessment of coronary artery response to paclitaxel-eluting stents using optical coherence tomography. Circ Cardiovasc Interv. 2012 Feb 1;5(1):30-8. doi: 10.1161/CIRCINTERVENTIONS.111.965582. Epub 2012 Jan 31.

    PubMed 22298797

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Taxus Libertè™ paclitaxel drug-eluting stent in people with Coronary Artery Disease, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.

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 4 inclusion and 7 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: finished, as of the sponsor's last update on 9 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of uncovered and/or malapposed Taxus Libertè struts at different time point after the implant, as measured by OCT (time frame: 3-6-9 months). 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 NCT00704145, which also lists 9 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 9 Feb 2010.

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