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

Ospedale della Misericordia

Status and phase: Unknown; Phase 4

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

Treatments: Device: Percutaneous coronary intervention: Uncoated balloon + Genous stent; Device: Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent; Device: Percutaneous coronary intervention: Drug eluting stent (Taxus stent)

Study type: Interventional

Funder types: Other

Identifiers

NCT00870038

Bernard1

Details and patient eligibility

About

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).

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

1

Experimental group

Description:

Paclitaxel eluting balloon (Elutax) + Genous stent

Treatment:

Device: Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent

2

Experimental group

Description:

Uncoated balloon + Genous stent

Treatment:

Device: Percutaneous coronary intervention: Uncoated balloon + Genous stent

3

Active Comparator group

Description:

Drug eluting stent (Taxus stent)

Treatment:

Device: Percutaneous coronary intervention: Drug eluting stent (Taxus stent)