Optical Coherence Tomography for Drug Eluting Stent Safety
NCT ID: NCT00693030
Last Updated: 2008-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
77 participants
INTERVENTIONAL
2006-08-31
2008-12-31
Brief Summary
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Detailed Description
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Patients if eligible on the basis of clinical and angiographic criteria, are randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. Stent implantation are done accordingly to the normal interventional practice. QCA and IVUS are performed at the end of optimal stents placement per visual judgement (residual stenosis \< 10%, TIMI 3 flow). Stent, lumen size and volume as well as complete stent strut apposal will be determined by IVUS analysis. Clinical follow-up will take place at 1 month (±1 week), 6 months (±2 weeks) and 1 year (±2 weeks). At 6-months follow-up all patients will undergo a quantitative coronary angiography (QCA), IVUS and Optical Coherence Tomography (LightLab OCT Imaging M2, automated pull back and flushing combination)assessments.
OCT images will be acquired at 15-30 frames per second. Blind corelab quantitative strut by strut analysis will be performed using a novel dedicated software at each 0.5 mm section. The following OCT variables will be evaluated:number of visualized strut per section, mean-max neointimal thickness per section, % struts well apposed with neointima at overlapping vs non overlapping sites, % struts without neointima, % struts malapposed, rate of \> 30% uncovered struts/total number of struts per section.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Device, Sirolimus drug-eluting stents implanted in overlap
sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)
comparison of multiple drug eluting stents
2
Device, paclitaxel polymer drug eluting stent
paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)
comparison of multiple drug eluting coronary stents
3
Device, zotarolimus drug eluting stent
zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)
comparison of multiple drug eluting coronary stents
4
bare metal coronary stents
Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)
comparison of DES in overlap vs BMS in overlap
Interventions
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sirolimus drug eluting coronary stent Cypher™ (Cordis Corp, Johnson & Johnson Co)
comparison of multiple drug eluting stents
paclitaxel polymer drug eluting stent Taxus Libertè™ (Boston Scientific, Natick MS)
comparison of multiple drug eluting coronary stents
zotarolimus drug eluting coronary stent Endeavor™ (Medtronic, Santa Rosa, CA)
comparison of multiple drug eluting coronary stents
Libertè bare metal coronary stent Libertè™ BMS(Boston Scientific, Natick, MS)
comparison of DES in overlap vs BMS in overlap
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Lesion length ≥ 20 mm,
3. Vessel size in between 2.5 and 3.5 mm.
4. Multiple, overlapped DES vs BMS placement (intention to overlap ≥ 4 mm)
5. Signed patient informed consent
Exclusion Criteria
2. lesions in coronary artery bypass grafts,
3. acute myocardial infarction,
4. poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%.
5. allergy to aspirin and or clopidogrel/ticlo,
6. renal failure with creatinine value \> 2.5,
7. no suitable anatomy for OCT scan
18 Years
ALL
No
Sponsors
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Case Western Reserve University
OTHER
Medtronic Vascular
INDUSTRY
Boston Scientific Corporation
INDUSTRY
A.O. Ospedale Papa Giovanni XXIII
OTHER
Responsible Party
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Cardiovascular Department Ospedali Riuniti di Bergamo ITALY
Principal Investigators
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Giulio Guagliumi, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Department Ospedali Riuniti di Bergamo
Locations
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Cardiovascular Department Ospedali Riuniti di Bergamo
Bergamo, , Italy
Countries
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Central Contacts
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Facility Contacts
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Giulio Guagliumi, MD
Role: primary
Giuseppe Musumeci, MD
Role: backup
References
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Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.
Finn AV, Kolodgie FD, Harnek J, Guerrero LJ, Acampado E, Tefera K, Skorija K, Weber DK, Gold HK, Virmani R. Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclitaxel-eluting stents. Circulation. 2005 Jul 12;112(2):270-8. doi: 10.1161/CIRCULATIONAHA.104.508937. Epub 2005 Jul 5.
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.
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.
Nakazawa G, Finn AV, John MC, Kolodgie FD, Virmani R. The significance of preclinical evaluation of sirolimus-, paclitaxel-, and zotarolimus-eluting stents. Am J Cardiol. 2007 Oct 22;100(8B):36M-44M. doi: 10.1016/j.amjcard.2007.08.020.
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.
Bouma BE, Tearney GJ, Yabushita H, Shishkov M, Kauffman CR, DeJoseph Gauthier D, MacNeill BD, Houser SL, Aretz HT, Halpern EF, Jang IK. Evaluation of intracoronary stenting by intravascular optical coherence tomography. Heart. 2003 Mar;89(3):317-20. doi: 10.1136/heart.89.3.317.
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.
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.
Guagliumi G, Musumeci G, Sirbu V, Bezerra HG, Suzuki N, Fiocca L, Matiashvili A, Lortkipanidze N, Trivisonno A, Valsecchi O, Biondi-Zoccai G, Costa MA; ODESSA Trial Investigators. Optical coherence tomography assessment of in vivo vascular response after implantation of overlapping bare-metal and drug-eluting stents. JACC Cardiovasc Interv. 2010 May;3(5):531-9. doi: 10.1016/j.jcin.2010.02.008.
Other Identifiers
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0106
Identifier Type: -
Identifier Source: org_study_id