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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Kidney Disease Multivessel Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Drug-eluting stent Xience V

Group Type ACTIVE_COMPARATOR

Coronary stent

Intervention Type DEVICE

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

Bare-metal stent Vision

Group Type ACTIVE_COMPARATOR

Coronary stent

Intervention Type DEVICE

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

Interventions

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Coronary stent

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

Intervention Type DEVICE

Other Intervention Names

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Bare metal stent Vision Drug-eluting stent Xience V

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No