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

Chronic Kidney Disease Clinical Trial

— RENAL-DES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818792
• Other study ID #: RENAL-DES
• Status: Completed
• Phase: Phase 2
• First received: January 7, 2009
• Last updated: January 14, 2013
• Start date: January 2009
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: European Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: September 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Coronary Artery Disease
• Coronary Disease
• Kidney Diseases
• Multivessel Coronary Artery Disease
• Myocardial Ischemia
• Renal Insufficiency, Chronic

Intervention

Device:
• Coronary stent
Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)

Locations

Country	Name	City	State
Italy	European Hospital	Rome
Italy	Azienda Ospedaliera Istituti Ospitalieri di Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
European Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemia-driven target vessel revascularization		9 months	No
Secondary	Incidence of death and myocardial infarction		in-hospital, 30 days, 9 and 12 months	Yes