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

Primary Purpose

Chronic Kidney Disease, Multivessel Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Coronary stent
Sponsored by
European Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Percutaneous coronary intervention, Drug-eluting stent, Chronic kidney disease, Restenosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • European Hospital
  • Azienda Ospedaliera Istituti Ospitalieri di Verona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Drug-eluting stent Xience V

Bare-metal stent Vision

Arm Description

Outcomes

Primary Outcome Measures

Ischemia-driven target vessel revascularization

Secondary Outcome Measures

Incidence of death and myocardial infarction

Full Information

First Posted
January 7, 2009
Last Updated
January 14, 2013
Sponsor
European Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00818792
Brief Title
Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease
Acronym
RENAL-DES
Official Title
A Multicenter, Randomized Trial to Compare Xience and Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Multivessel Coronary Artery Disease
Keywords
Percutaneous coronary intervention, Drug-eluting stent, Chronic kidney disease, Restenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug-eluting stent Xience V
Arm Type
Active Comparator
Arm Title
Bare-metal stent Vision
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Coronary stent
Other Intervention Name(s)
Bare metal stent Vision, Drug-eluting stent Xience V
Intervention Description
Comparison of bare-metal stent (Vision) and drug-eluting stent (Xience V)
Primary Outcome Measure Information:
Title
Ischemia-driven target vessel revascularization
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Incidence of death and myocardial infarction
Time Frame
in-hospital, 30 days, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrizio Tomai, MD
Organizational Affiliation
Department of Cardiovascular Sciences, European Hospital, Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
European Hospital
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Azienda Ospedaliera Istituti Ospitalieri di Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17606856
Citation
Schiffrin EL, Lipman ML, Mann JF. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007 Jul 3;116(1):85-97. doi: 10.1161/CIRCULATIONAHA.106.678342.
Results Reference
background
PubMed Identifier
17909090
Citation
Tomai F, Reimers B, De Luca L, Galassi AR, Gaspardone A, Ghini AS, Ferrero V, Favero L, Gioffre 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. doi: 10.2337/dc07-1377. Epub 2007 Oct 1.
Results Reference
background
PubMed Identifier
24357403
Citation
Tomai F, Ribichini F, De Luca L, Petrolini A, Ghini AS, Weltert L, Spaccarotella C, Proietti I, Trani C, Nudi F, Pighi M, Vassanelli C. Randomized Comparison of Xience V and Multi-Link Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease (RENAL-DES) Study. Circulation. 2014 Mar 11;129(10):1104-12. doi: 10.1161/CIRCULATIONAHA.113.005186. Epub 2013 Dec 19.
Results Reference
derived
PubMed Identifier
19924001
Citation
Tomai F, Petrolini A, De Luca L, Nudi F, Lanza G, Vassanelli C, Ribichini F. Rationale and design of the Randomized comparison of XiEnce V and Multilink VisioN coronary stents in the sAme muLtivessel patient with chronic kiDnEy disease (RENAL-DES) study. J Cardiovasc Med (Hagerstown). 2010 Apr;11(4):310-7. doi: 10.2459/JCM.0b013e3283347e24.
Results Reference
derived

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

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