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

Phase 4

• Conditions: Angioplasty, Transluminal, Percutaneous Coronary; Percutaneous Coronary Intervention

• Registration Number: NCT00870038
• Lead Sponsor: Ospedale della Misericordia

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-03
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Last Update Submitted: 2010-07-21
• Last Update Posted: 2010-07-22
• Study Start: 2010-12
• Primary Completion: 2011-08
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Late luminal loss between the three groups at 6 months angiographic follow up.	6 months
Percent of stent struts covered by endothelium at optical coherence tomography, during 6 months angiographic follow up.	6 months

Secondary Outcome Measures

Name	Time	Method
Angiographic restenosis (6 months angiographic follow up).	6 months
Net adverse clinical events at 6 months (death, myocardial infarction, target lesion revascularization, bleedings as from Acuity scale).	6 months

Trial Locations

Locations (1)

U.O. Emodinamica, Ospedale della Misericordia; 🇮🇹 Grosseto, Italy