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

Purpose

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
Chronic Kidney Disease Multivessel Coronary Artery Disease	Device: Coronary stent	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized Trial to Compare Xience and Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by European Hospital:

Primary Outcome Measures:

Ischemia-driven target vessel revascularization [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of death and myocardial infarction [ Time Frame: in-hospital, 30 days, 9 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	215
Study Start Date:	January 2009
Study Completion Date:	September 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Drug-eluting stent Xience V	Device: Coronary stent Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V) Other Names: Bare metal stent Vision Drug-eluting stent Xience V
Active Comparator: Bare-metal stent Vision	Device: Coronary stent Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V) Other Names: Bare metal stent Vision Drug-eluting stent Xience V

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818792

Locations

Italy
European Hospital
Rome, Italy, 00149
Azienda Ospedaliera Istituti Ospitalieri di Verona
Verona, Italy, 37126

Sponsors and Collaborators

European Hospital

Investigators

Principal Investigator:

Fabrizio Tomai, MD

Department of Cardiovascular Sciences, European Hospital, Rome

More Information

Publications:

Schiffrin EL, Lipman ML, Mann JF. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007 Jul 3;116(1):85-97. Review.

Tomai F, Reimers B, De Luca L, Galassi AR, Gaspardone A, Ghini AS, Ferrero V, Favero L, Gioffrè 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. Epub 2007 Oct 1.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Fabrizio Tomai, MD, FACC, FESC, European Hospital
ClinicalTrials.gov Identifier:	NCT00818792 History of Changes
Other Study ID Numbers:	RENAL-DES
Study First Received:	January 7, 2009
Last Updated:	January 14, 2013
Health Authority:	Italy: Ethics Committee

Keywords provided by European Hospital:

Percutaneous coronary intervention
Drug-eluting stent
Chronic kidney disease
Restenosis

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013

Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease (RENAL-DES)