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

January 14, 2013 updated by: Fabrizio Tomai, European Hospital

A Multicenter, Randomized Trial to Compare 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ischemia-driven target vessel revascularization
Time Frame: 9 months
9 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Hospital

Investigators

  • Principal Investigator: Fabrizio Tomai, MD, Department of Cardiovascular Sciences, European Hospital, Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 7, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (Estimate)

January 8, 2009

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RENAL-DES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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