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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting stent Xience V | Active Comparator |
| |
| Bare-metal stent Vision | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary stent | Device | Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ischemia-driven target vessel revascularization | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of death and myocardial infarction | in-hospital, 30 days, 9 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrizio Tomai, MD | Department of Cardiovascular Sciences, European Hospital, Rome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Hospital | Rome | 00149 | Italy | |||
| Azienda Ospedaliera Istituti Ospitalieri di Verona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17606856 | Background | Schiffrin EL, Lipman ML, Mann JF. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007 Jul 3;116(1):85-97. doi: 10.1161/CIRCULATIONAHA.106.678342. | |
| 17909090 | Background | Tomai F, Reimers B, De Luca L, Galassi AR, Gaspardone A, Ghini AS, Ferrero V, Favero L, Gioffre G, Prati F, Tamburino C, Ribichini F. Head-to-head comparison of sirolimus- and paclitaxel-eluting stent in the same diabetic patient with multiple coronary artery lesions: a prospective, randomized, multicenter study. Diabetes Care. 2008 Jan;31(1):15-9. doi: 10.2337/dc07-1377. Epub 2007 Oct 1. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Verona |
| 37126 |
| Italy |
| 24357403 | Derived | Tomai F, Ribichini F, De Luca L, Petrolini A, Ghini AS, Weltert L, Spaccarotella C, Proietti I, Trani C, Nudi F, Pighi M, Vassanelli C. Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease (RENAL-DES) Study. Circulation. 2014 Mar 11;129(10):1104-12. doi: 10.1161/CIRCULATIONAHA.113.005186. Epub 2013 Dec 19. |
| 19924001 | Derived | Tomai F, Petrolini A, De Luca L, Nudi F, Lanza G, Vassanelli C, Ribichini F. Rationale and design of the Randomized comparison of XiEnce V and Multilink VisioN coronary stents in the sAme muLtivessel patient with chronic kiDnEy disease (RENAL-DES) study. J Cardiovasc Med (Hagerstown). 2010 Apr;11(4):310-7. doi: 10.2459/JCM.0b013e3283347e24. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |