Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease (OCTAXUS)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Taxus Libertè™ paclitaxel drug-eluting stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug Eluting Stents, Percutaneous Coronary Interventions, Optical Coherence Tomography
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Ospedali Riuniti di Bergamo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Device, paclitaxel drug-eluting stent
Outcomes
Primary Outcome Measures
Proportion of uncovered and/or malapposed Taxus Libertè struts at different time point after the implant, as measured by OCT
Secondary Outcome Measures
% Incomplete apposition at different point of FU (3-6-9 months)
Proportion of neointima disomogeneity around struts at different point of FU (3-6-9 months)
OCT Neointima thickness overtime
Ischemia Driven Target Vessel Failure (ID-TVF) rate at 12 months
Adjudicated MACE rate at 30 days and 12 months
Full Information
NCT ID
NCT00704145
First Posted
June 20, 2008
Last Updated
February 5, 2010
Sponsor
A.O. Ospedale Papa Giovanni XXIII
Collaborators
Case Western Reserve University, Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00704145
Brief Title
Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease
Acronym
OCTAXUS
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
A.O. Ospedale Papa Giovanni XXIII
Collaborators
Case Western Reserve University, Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Drug Eluting Stents, Percutaneous Coronary Interventions, Optical Coherence Tomography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Device, paclitaxel drug-eluting stent
Intervention Type
Device
Intervention Name(s)
Taxus Libertè™ paclitaxel drug-eluting stent
Other Intervention Name(s)
Taxus Libertè™ (Boston Scientific,Natick,MS)
Intervention Description
device:Taxus Libertè™ (Boston Scientific,Natick,MS)assessed at different time points after implant
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
% Incomplete apposition at different point of FU (3-6-9 months)
Time Frame
3-6-9 months
Title
Proportion of neointima disomogeneity around struts at different point of FU (3-6-9 months)
Time Frame
3-6-9 months
Title
OCT Neointima thickness overtime
Time Frame
3-6-9 months
Title
Ischemia Driven Target Vessel Failure (ID-TVF) rate at 12 months
Time Frame
12 months
Title
Adjudicated MACE rate at 30 days and 12 months
Time Frame
30 days and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giulio Guagliumi, MD
Organizational Affiliation
Cardiovascular Department Ospedali Riuniti di Bergamo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
17510464
Citation
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.
Results Reference
background
PubMed Identifier
17438147
Citation
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.
Results Reference
background
PubMed Identifier
18413495
Citation
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.
Results Reference
background
PubMed Identifier
16209986
Citation
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.
Results Reference
background
PubMed Identifier
16386687
Citation
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.
Results Reference
background
PubMed Identifier
17135281
Citation
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.
Results Reference
background
PubMed Identifier
17437723
Citation
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.
Results Reference
background
PubMed Identifier
18307999
Citation
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.
Results Reference
background
PubMed Identifier
22298797
Citation
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.
Results Reference
derived
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Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease
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