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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00870038

Acronym

EREMUS

Enrollment

Registered

2009-03-26

Start date

2010-12-31

Completion date

2012-01-31

Last updated

2010-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty, Transluminal, Percutaneous Coronary, Percutaneous Coronary Intervention

Keywords

PCI, stent, drug eluting stent, reendothelialization, restenosis, Percutaneous Coronary Angioplasty

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).

Interventions

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

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

DEVICEPercutaneous coronary intervention: Uncoated balloon + Genous stent

Predilatation with uncoated balloon, the stenting with Genous stent.

DEVICEPercutaneous coronary intervention: Drug eluting stent (Taxus stent)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Italy

Contacts

Primary ContactBernardo Cortese, MD

bcortese@gmail.com+39 02 55033507

Backup ContactUgo Limbruno, MD, PhD

bcortese@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026