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

Study Overview
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Brief Summary
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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).

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

Conditions
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Angioplasty, Transluminal, Percutaneous Coronary, Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent
* Device: Percutaneous coronary intervention: Uncoated balloon + Genous stent
* Device: Percutaneous coronary intervention: Drug eluting stent (Taxus stent)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Paclitaxel eluting balloon (Elutax) + Genous stent | Device: Percutaneous coronary intervention: Paclitaxel eluting balloon (Elutax) + Genous stent<br>* Predilatation with paclitaxel-eluting balloon, then stenting of the lesion with Genous stent<br>* Other names: Genous stent, Orbus Neich, Fort Lauderdale, FL.;|
| Experimental: 2<br>Uncoated balloon + Genous stent | Device: Percutaneous coronary intervention: Uncoated balloon + Genous stent<br>* Predilatation with uncoated balloon, the stenting with Genous stent.<br>* Other names: Genous stent, Orbus Neich, Fort Lauderdale, FL.;|
| Active Comparator: 3<br>Drug eluting stent (Taxus stent) | Device: Percutaneous coronary intervention: Drug eluting stent (Taxus stent)<br>* Predilatation with uncoated balloon, the placement of a Taxus stent.<br>* Other names: Taxus stent, Boston Scientific, Natick, MA.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, drug eluting stent, reendothelialization, restenosis, Percutaneous Coronary Angioplasty, PCI