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

Ospedale della Misericordia75 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Angioplasty, Transluminal, Percutaneous Coronary Percutaneous Coronary Intervention

Interventions

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

Predilatation with paclitaxel-eluting balloon, then stenting of the lesion with Genous stent

Percutaneous coronary intervention: Uncoated balloon + Genous stentDEVICE

Predilatation with uncoated balloon, the stenting with Genous stent.

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

Predilatation with uncoated balloon, the placement of a Taxus stent.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

U.O. Emodinamica, Ospedale della Misericordia

Grosseto, Italy

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).

Time frame: 6 months

Net adverse clinical events at 6 months (death, myocardial infarction, target lesion revascularization, bleedings as from Acuity scale).

Time frame: 6 months

Central Contacts

Bernardo Cortese, MD

CONTACT

+39 02 55033507 bcortese@gmail.com

Ugo Limbruno, MD, PhD

CONTACT

bcortese@gmail.com

Data from ClinicalTrials.gov

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