Clinical trial NCT00704145: Optical Coherence Tomography Following Paclitaxel Eluting Stent Implantation in Multivessel Coronary Artery Disease
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Drug Eluting Stents
Percutaneous Coronary Interventions
Optical Coherence Tomography
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: Boston Scientific Corporation
First posted: 2008-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of uncovered and/or malapposed Taxus Libertè struts at different time point after the implant, as measured by OCT
timeFrame: 3-6-9 months
Secondary outcomes:
measure: % Incomplete apposition at different point of FU (3-6-9 months)
timeFrame: 3-6-9 months
measure: Proportion of neointima disomogeneity around struts at different point of FU (3-6-9 months)
timeFrame: 3-6-9 months
measure: OCT Neointima thickness overtime
timeFrame: 3-6-9 months
measure: Ischemia Driven Target Vessel Failure (ID-TVF) rate at 12 months
timeFrame: 12 months
measure: Adjudicated MACE rate at 30 days and 12 months
timeFrame: 30 days and 12 months
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
Study officials:
affiliation: Cardiovascular Department Ospedali Riuniti di Bergamo
name: Giulio Guagliumi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.