Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease

Study Overview
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Brief Summary
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Percutaneous coronary intervention (PCI) with bare metal stent (BMS) in patients with renal insufficiency has shown unsatisfactory results. Indeed, drug-eluting stents (DES) might reduce the incidence of restenosis and therefore of target lesion revascularization procedures in these patients. We therefore designed a prospective, randomized, multicenter, not-sponsored study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and bare-metal stent (Vision) (both 2nd-generation DES and BMS, respectively), both implanted in the same patient with multivessel disease and renal insufficiency in order to obviate for the multiple and unpredictable characteristics of this high-risk population.

Official Title
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A Multicenter, Randomized Trial to Compare Xience and Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease

Conditions
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Chronic Kidney Disease, Multivessel Coronary Artery Disease

Intervention / Treatment
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* Device: Coronary stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic renal insufficiency (creatinine clearance <60 ml/min, in dialysis patients included) with at least two significant (>70%) coronary lesions in two major coronary vessels. Exclusion Criteria: Age >85 years left main coronary artery disease saphenous vein graft disease ST-elevation MI (<3 days) coronary vessel diameter <2.5 or > 4 mm contraindication to long-term double antiplatelet therapy CABG indication by consensus (cardiovascular team) severe valvular heart disease informed consent not obtained

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug-eluting stent Xience V<br> | Device: Coronary stent<br>* Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)<br>* Other names: Drug-eluting stent Xience V;|
| Active Comparator: Bare-metal stent Vision<br> | Device: Coronary stent<br>* Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)<br>* Other names: Drug-eluting stent Xience V;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia-driven target vessel revascularization |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of death and myocardial infarction |  | in-hospital, 30 days, 9 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous coronary intervention, Drug-eluting stent, Chronic kidney disease, Restenosis