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

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704145
• Other study ID #: 1087/2007
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2008
• Last updated: February 5, 2010
• Start date: November 2007
• Est. completion date: November 2009

Study information

• Verified date: February 2010
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Multivessel coronary artery disease (two or 3 VD) to be treated at 2 sequences (staged procedures) with paclitaxel-polymer eluting stents

2. Native coronary artery disease with >= 75% diameter stenosis

3. Vessel size in between 2.5 and 3.5 mm.

4. Written informed consent signed

Exclusion Criteria:

1. No suitable anatomy for OCT scan: (truly ostial , tortuous anatomy, very distal lesions or vessels larger than 3.75 in reference diameter).

2. significant left main coronary artery disease,

3. lesions in bypass grafts,

4. acute myocardial infarction,

5. poor cardiac function as defined by left ventricular ejection fraction = 30%.

6. allergy to aspirin and or clopidogrel/ticlopidine,

7. Renal failure with creatinine value > 2.5 mg/dl

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Taxus Libertè™ paclitaxel drug-eluting stent
device:Taxus Libertè™ (Boston Scientific,Natick,MS)assessed at different time points after implant

Locations

Country	Name	City	State
Italy	Ospedali Riuniti di Bergamo	Bergamo

Sponsors (3)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII	Boston Scientific Corporation, Case Western Reserve University

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View 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. Epub 2007 Apr 16. — View 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. Epub 2007 May 17. Review. — View 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. Epub 2006 Nov 29. — View 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. — View 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. Epub 2005 Dec 9. — View 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. Epub 2007 Feb 23. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of uncovered and/or malapposed Taxus Libertè struts at different time point after the implant, as measured by OCT		3-6-9 months	Yes
Secondary	% Incomplete apposition at different point of FU (3-6-9 months)		3-6-9 months	Yes
Secondary	Proportion of neointima disomogeneity around struts at different point of FU (3-6-9 months)		3-6-9 months	Yes
Secondary	OCT Neointima thickness overtime		3-6-9 months	No
Secondary	Ischemia Driven Target Vessel Failure (ID-TVF) rate at 12 months		12 months	Yes
Secondary	Adjudicated MACE rate at 30 days and 12 months		30 days and 12 months	Yes