Clinical trial NCT00870038: To Achieve an Early Reendothelialization at the Expense of Low Restenosis: The EREMUS Study
Official title: Early Re-Endothelialization Might Not be the Unique Solution to Prevent Restenosis. The EREMUS Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Angioplasty, Transluminal, Percutaneous Coronary
Percutaneous Coronary Intervention
Keywords: PCI
stent
drug eluting stent
reendothelialization
restenosis
Percutaneous Coronary Angioplasty
Lead sponsor: Ospedale della Misericordia
Sponsor class: OTHER
First posted: 2009-03-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators sought to discover which one of the following strategies is the safest for patients undergoing percutaneous coronary intervention: paclitaxel-coated balloon+Genous stent; Genous stent; drug eluting stent (paclitaxel).


Eligibility criteria: Inclusion Criteria:

* Stable or unstable angina pectoris suitable to PCI of at least one coronary vessel
* Age \>18 years

Exclusion Criteria:

* Recent (\<72 hours) acute myocardial infarction
* Creatinine clearance \<40 ml/min
* Allergy or hypersensitivity to at least two between: aspirin, clopidogrel, heparin, bivalirudin, paclitaxel, contrast media
* Life expectancy \<1 year

Primary outcomes:
measure: Late luminal loss between the three groups at 6 months angiographic follow up.
timeFrame: 6 months
measure: Percent of stent struts covered by endothelium at optical coherence tomography, during 6 months angiographic follow up.
timeFrame: 6 months
Secondary outcomes:
measure: Angiographic restenosis (6 months angiographic follow up).
timeFrame: 6 months
measure: Net adverse clinical events at 6 months (death, myocardial infarction, target lesion revascularization, bleedings as from Acuity scale).
timeFrame: 6 months
Other outcomes:
Locations:
city: Grosseto
country: Italy
facility: U.O. Emodinamica, Ospedale della Misericordia
Study officials:
affiliation: Ospedale Maggiore Policlinico, Milano, Italy
name: Bernardo Cortese, MD, FESC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.