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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00818792

Acronym

RENAL-DES

Enrollment

215

Registered

2009-01-08

Start date

2009-01-31

Completion date

2012-09-30

Last updated

2013-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Multivessel Coronary Artery Disease

Keywords

Percutaneous coronary intervention, Drug-eluting stent, Chronic kidney disease, Restenosis

Brief 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.

Interventions

DEVICECoronary stent

Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Ischemia-driven target vessel revascularization	9 months

Secondary

Measure	Time frame
Incidence of death and myocardial infarction	in-hospital, 30 days, 9 and 12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026