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Sponsored by: |
European Hospital |
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Information provided by: | European Hospital |
ClinicalTrials.gov Identifier: | NCT00818792 |
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.
Condition | Intervention | Phase |
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Chronic Kidney Disease Multivessel Coronary Artery Disease |
Device: Coronary stent |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized Trial to Compare Xience and Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease |
Estimated Enrollment: | 220 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Drug-eluting stent Xience V: Active Comparator |
Device: Coronary stent
Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)
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Bare-metal stent Vision: Active Comparator |
Device: Coronary stent
Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Department of Cardiovascular Sciences, European Hospital, Rome, Italy ( Fabrizio Tomai ) |
Study ID Numbers: | RENAL-DES |
Study First Received: | January 7, 2009 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00818792 History of Changes |
Health Authority: | Italy: Ethics Committee |
Percutaneous coronary intervention Drug-eluting stent Chronic kidney disease Restenosis |
Arterial Occlusive Diseases Renal Insufficiency Heart Diseases Myocardial Ischemia Kidney Failure, Chronic Vascular Diseases Ischemia |
Arteriosclerosis Coronary Disease Urologic Diseases Renal Insufficiency, Chronic Kidney Diseases Coronary Artery Disease Kidney Failure |
Arterial Occlusive Diseases Renal Insufficiency Heart Diseases Myocardial Ischemia Kidney Failure, Chronic Vascular Diseases Arteriosclerosis |
Coronary Disease Urologic Diseases Renal Insufficiency, Chronic Cardiovascular Diseases Kidney Diseases Coronary Artery Disease Kidney Failure |