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

Ospedale della Misericordia1 site in 1 country75 target enrollmentDecember 2010

ConditionsAngioplasty, Transluminal, Percutaneous Coronary Percutaneous Coronary Intervention

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Angioplasty, Transluminal, Percutaneous Coronary
Sponsor: Ospedale della Misericordia
Enrollment: 75
Locations: 1
Primary Endpoint: Late luminal loss between the three groups at 6 months angiographic follow up.
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

January 2012

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ospedale della Misericordia

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

Outcomes

Primary Outcomes

Late luminal loss between the three groups at 6 months angiographic follow up.

Time Frame: 6 months

Percent of stent struts covered by endothelium at optical coherence tomography, during 6 months angiographic follow up.

Time Frame: 6 months

Secondary Outcomes

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)