NCT00704145

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 9, 2010

Status Verified

February 1, 2010

Enrollment Period

1.8 years

First QC Date

June 20, 2008

Last Update Submit

February 5, 2010

Conditions

Coronary Artery Disease

Keywords

Drug Eluting StentsPercutaneous Coronary InterventionsOptical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

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

    3-6-9 months

Secondary Outcomes (5)

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

    3-6-9 months

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

    3-6-9 months

  • OCT Neointima thickness overtime

    3-6-9 months

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

    12 months

  • Adjudicated MACE rate at 30 days and 12 months

    30 days and 12 months

Study Arms (1)

A

EXPERIMENTAL

Device, paclitaxel drug-eluting stent

Device: Taxus Libertè™ paclitaxel drug-eluting stent

Interventions

Taxus Libertè™ paclitaxel drug-eluting stentDEVICE

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

Also known as: Taxus Libertè™ (Boston Scientific,Natick,MS)
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

Location

Related Publications (9)

  • 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.

    PMID: 17510464BACKGROUND

  • 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.

    PMID: 17438147BACKGROUND

  • 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.

    PMID: 18413495BACKGROUND

  • 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.

    PMID: 16209986BACKGROUND

  • 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.

    PMID: 16386687BACKGROUND

  • 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.

    PMID: 17135281BACKGROUND

  • 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.

    PMID: 17437723BACKGROUND

  • 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.

    PMID: 18307999BACKGROUND

  • 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.

    PMID: 22298797DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Giulio Guagliumi, MD

    Cardiovascular Department Ospedali Riuniti di Bergamo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 24, 2008

Study Start

November 1, 2007

Primary Completion

August 1, 2009

Study Completion

November 1, 2009

Last Updated

February 9, 2010

Record last verified: 2010-02

Locations

IT(1)