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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fabrizio Tomai, European Hospital
ClinicalTrials.gov Identifier:
NCT00818792
First received: January 7, 2009
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Multivessel Coronary Artery Disease
Device: Coronary stent
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by European Hospital:

Primary Outcome Measures:
  • Ischemia-driven target vessel revascularization [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of death and myocardial infarction [ Time Frame: in-hospital, 30 days, 9 and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 215
Study Start Date: January 2009
Study Completion Date: September 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Additional 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
Study First Received: January 7, 2009
Last Updated: January 14, 2013
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 18, 2014