A Multicenter, Randomized Trial to Compare Xience and Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 215
- Locations
- 4
- Primary Endpoint
- Ischemia-driven target vessel revascularization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Ischemia-driven target vessel revascularization
Time Frame: 9 months
Secondary Outcomes
- Incidence of death and myocardial infarction(in-hospital, 30 days, 9 and 12 months)
Investigators
Fabrizio Tomai
MD, FACC, FESC
European Hospital