To Achieve an Early Reendothelialization at the Expense of Low Restenosis: The EREMUS Study
NCT ID: NCT00870038
Last Updated: 2010-07-22
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
75 participants
INTERVENTIONAL
2010-12-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Paclitaxel eluting balloon (Elutax) + Genous stent
Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent
Predilatation with paclitaxel-eluting balloon, then stenting of the lesion with Genous stent
2
Uncoated balloon + Genous stent
Percutaneous coronary intervention: Uncoated balloon + Genous stent
Predilatation with uncoated balloon, the stenting with Genous stent.
3
Drug eluting stent (Taxus stent)
Percutaneous coronary intervention: Drug eluting stent (Taxus stent)
Predilatation with uncoated balloon, the placement of a Taxus stent.
Interventions
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Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent
Predilatation with paclitaxel-eluting balloon, then stenting of the lesion with Genous stent
Percutaneous coronary intervention: Uncoated balloon + Genous stent
Predilatation with uncoated balloon, the stenting with Genous stent.
Percutaneous coronary intervention: Drug eluting stent (Taxus stent)
Predilatation with uncoated balloon, the placement of a Taxus stent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>18 years
Exclusion Criteria
* Creatinine clearance \<40 ml/min
* Allergy or hypersensitivity to at least two between: aspirin, clopidogrel, heparin, bivalirudin, paclitaxel, contrast media
* Life expectancy \<1 year
18 Years
85 Years
ALL
No
Sponsors
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Ospedale della Misericordia
OTHER
Responsible Party
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Ospedale della Misericordia
Principal Investigators
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Bernardo Cortese, MD, FESC
Role: PRINCIPAL_INVESTIGATOR
Ospedale Maggiore Policlinico, Milano, Italy
Locations
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U.O. Emodinamica, Ospedale della Misericordia
Grosseto, , Italy
Countries
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Central Contacts
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References
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Alfonso F, Zueco J, Cequier A, Mantilla R, Bethencourt A, Lopez-Minguez JR, Angel J, Auge JM, Gomez-Recio M, Moris C, Seabra-Gomes R, Perez-Vizcayno MJ, Macaya C; Restenosis Intra-stent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators. A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis. J Am Coll Cardiol. 2003 Sep 3;42(5):796-805. doi: 10.1016/s0735-1097(03)00852-0.
Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.
Aoki J, Serruys PW, van Beusekom H, Ong AT, McFadden EP, Sianos G, van der Giessen WJ, Regar E, de Feyter PJ, Davis HR, Rowland S, Kutryk MJ. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First In Man) Registry. J Am Coll Cardiol. 2005 May 17;45(10):1574-9. doi: 10.1016/j.jacc.2005.01.048.
Co M, Tay E, Lee CH, Poh KK, Low A, Lim J, Lim IH, Lim YT, Tan HC. Use of endothelial progenitor cell capture stent (Genous Bio-Engineered R Stent) during primary percutaneous coronary intervention in acute myocardial infarction: intermediate- to long-term clinical follow-up. Am Heart J. 2008 Jan;155(1):128-32. doi: 10.1016/j.ahj.2007.08.031. Epub 2007 Nov 26.
Stone GW, White HD, Ohman EM, Bertrand ME, Lincoff AM, McLaurin BT, Cox DA, Pocock SJ, Ware JH, Feit F, Colombo A, Manoukian SV, Lansky AJ, Mehran R, Moses JW; Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial investigators. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial. Lancet. 2007 Mar 17;369(9565):907-19. doi: 10.1016/S0140-6736(07)60450-4.
Cortese B, Danzi GB, Piti A, Severi S, Limbruno U. Rationale and design of the randomized, multicenter EREMUS trial, a study that investigates how to achieve low restenosis and early reendothelialization after percutaneous coronary interventions. Catheter Cardiovasc Interv. 2011 Jul 1;78(1):32-7. doi: 10.1002/ccd.22856. Epub 2011 Mar 16.
Other Identifiers
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Bernard1
Identifier Type: -
Identifier Source: org_study_id
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