ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00818792
Recruitment Status : Completed
First Posted : January 8, 2009
Last Update Posted : January 15, 2013
Sponsor:
Information provided by (Responsible Party):
Fabrizio Tomai, European Hospital

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Multivessel Coronary Artery Disease Device: Coronary stent Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Trial to Compare Xience and Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease
Study Start Date : January 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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




Primary Outcome Measures :
  1. Ischemia-driven target vessel revascularization [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Incidence of death and myocardial infarction [ Time Frame: in-hospital, 30 days, 9 and 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00818792


Locations
Italy
European Hospital
Rome, Italy, 00149
Azienda Ospedaliera Istituti Ospitalieri di Verona
Verona, Italy, 37126
Sponsors and Collaborators
European Hospital
Investigators
Principal Investigator: Fabrizio Tomai, MD Department of Cardiovascular Sciences, European Hospital, Rome

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fabrizio Tomai, MD, FACC, FESC, European Hospital
ClinicalTrials.gov Identifier: NCT00818792     History of Changes
Other Study ID Numbers: RENAL-DES
First Posted: January 8, 2009    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by Fabrizio Tomai, European Hospital:
Percutaneous coronary intervention
Drug-eluting stent
Chronic kidney disease
Restenosis

Additional relevant MeSH terms:
Kidney Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Renal Insufficiency, Chronic
Urologic Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Renal Insufficiency