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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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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

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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

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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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