To Achieve an Early Reendothelialization at the Expense of Low Restenosis: The EREMUS Study

Percutaneous Coronary Intervention Clinical Trial

— EREMUS  

Official title:

Early Re-Endothelialization Might Not be the Unique Solution to Prevent Restenosis. The EREMUS Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00870038
• Other study ID #: Bernard1
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 25, 2009
• Last updated: July 21, 2010
• Start date: December 2010
• Est. completion date: January 2012

Study information

• Verified date: March 2009
• Source: Ospedale della Misericordia
• Contact: Bernardo Cortese, MD
• Phone: +39 02 55033507
• Email: bcortese[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: January 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioplasty, Transluminal, Percutaneous Coronary
• Percutaneous Coronary Intervention

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	U.O. Emodinamica, Ospedale della Misericordia	Grosseto

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale della Misericordia

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Alfonso F, Zueco J, Cequier A, Mantilla R, Bethencourt A, López-Minguez JR, Angel J, Augé JM, Gómez-Recio M, Morís C, Seabra-Gomes R, Perez-Vizcayno MJ, Macaya C; Restenosis Intra-stent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators. A — View 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 Endothe — View 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-ter — View Citation

Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schömig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabaté M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, D — View 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. Biv — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late luminal loss between the three groups at 6 months angiographic follow up.		6 months	No
Primary	Percent of stent struts covered by endothelium at optical coherence tomography, during 6 months angiographic follow up.		6 months	Yes
Secondary	Angiographic restenosis (6 months angiographic follow up).		6 months	No
Secondary	Net adverse clinical events at 6 months (death, myocardial infarction, target lesion revascularization, bleedings as from Acuity scale).		6 months	Yes