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

NCT00818792 | Completed Phase 2 DMC

• 1 other identifier: RENAL-DES
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Disease; Multivessel Coronary Artery Disease

Keywords

Percutaneous coronary intervention; Drug-eluting stent; Chronic kidney disease; Restenosis

Outcome Measures

Primary Outcomes (1)

• Ischemia-driven target vessel revascularization

  9 months

Secondary Outcomes (1)

• Incidence of death and myocardial infarction

  in-hospital, 30 days, 9 and 12 months

Study Arms (2)

Drug-eluting stent Xience V

ACTIVE COMPARATOR

Device: Coronary stent

Bare-metal stent Vision

ACTIVE COMPARATOR

Device: Coronary stent

Interventions

Coronary stent DEVICE

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

Also known as: Bare metal stent Vision, Drug-eluting stent Xience V

Bare-metal stent Vision; Drug-eluting stent Xience V

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• European Hospital: lead

Study Sites (2)

European Hospital

Rome, 00149, Italy

Location

Azienda Ospedaliera Istituti Ospitalieri di Verona

Verona, 37126, Italy

Location

Related Publications (4)

• 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.

  PMID: 17606856 BACKGROUND

• 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.

  PMID: 17909090 BACKGROUND

• 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.

  PMID: 24357403 DERIVED

• 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.

  PMID: 19924001 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabrizio Tomai, MD

  Department of Cardiovascular Sciences, European Hospital, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FACC, FESC

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 8, 2009
• Study Start: January 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

IT (2)