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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00818792
Other study ID # RENAL-DES
Secondary ID
Status Completed
Phase Phase 2
First received January 7, 2009
Last updated January 14, 2013
Start date January 2009
Est. completion date September 2012

Study information

Verified date January 2013
Source European Hospital
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 215
Est. completion date September 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Italy European Hospital Rome
Italy Azienda Ospedaliera Istituti Ospitalieri di Verona Verona

Sponsors (1)

Lead Sponsor Collaborator
European Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Schiffrin EL, Lipman ML, Mann JF. Chronic kidney disease: effects on the cardiovascular system. Circulation. 2007 Jul 3;116(1):85-97. Review. — View Citation

Tomai F, Reimers B, De Luca L, Galassi AR, Gaspardone A, Ghini AS, Ferrero V, Favero L, Gioffrè 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. Epub 2007 Oct 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Ischemia-driven target vessel revascularization 9 months No
Secondary Incidence of death and myocardial infarction in-hospital, 30 days, 9 and 12 months Yes
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