Randomized Comparison of 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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Multivessel Coronary Artery Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

European Hospital, Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary stent

Device

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

Other names: Bare metal stent Vision, Drug-eluting stent Xience V

Primary outcomes

Ischemia-driven target vessel revascularization

Time frame: 9 months

Secondary outcomes

Incidence of death and myocardial infarction

Time frame: in-hospital, 30 days, 9 and 12 months

Sponsors and collaborators

Lead sponsor

European Hospital

Other

Registry information

Official study title

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

Acronym: RENAL-DES

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Jan 8, 2009
Registry last updated: Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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