- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00818792
Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease (RENAL-DES)
A Multicenter, Randomized Trial to Compare Xience and Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
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Rome, Italien, 00149
- European Hospital
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Verona, Italien, 37126
- Azienda Ospedaliera Istituti Ospitalieri di Verona
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Drug-eluting stent Xience V
|
Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)
Andre navne:
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Aktiv komparator: Bare-metal stent Vision
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Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Ischemia-driven target vessel revascularization
Tidsramme: 9 months
|
9 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Incidence of death and myocardial infarction
Tidsramme: in-hospital, 30 days, 9 and 12 months
|
in-hospital, 30 days, 9 and 12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Fabrizio Tomai, MD, Department of Cardiovascular Sciences, European Hospital, Rome
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RENAL-DES
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