Stable Angina, Unstable Angina, Coronary Artery Disease, Saphenous Vein Graft Disease
Conditions
Brief summary
Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in native coronary arteries reducing the occurrence of restenosis and repeated revascularization, however saphenous vein grafts have been always excluded form randomized trials. Objective: To evaluate the angiographic and clinical impact of sirolimus-eluting-stents with respect to bare-metal-stents in degenerated vein grafts. Design: Double-blind randomized controlled non-industry-sponsored trial. Setting: A single-center tertiary-care referral hospital. Patients: All patients are randomly allocated to sirolimus-eluting-stent implantation or the corresponding bare-metal-stent. All patients are followed clinically and repeated angiographic follow-up is performed in all at 6-months. Main outcome measure: Primary end-point is 6-months angiographic in-stent late loss. Secondary end-points include: binary angiographic in-stent and in-segment restenosis, intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events (death, myocardial infarction, target-lesion and target-vessel revascularization).
Interventions
DEVICEsirolimus-eluting stent
DEVICEbare metal stent
Sponsors
Antwerp Cardiovascular Institute Middelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 85 years-old * clear signs and/or symptoms of stable or unstable angina or documented silent ischemia * one or more de-novo target lesions (\>50% diameter stenosis by visual estimate) localized in one or more diseased SVG with a reference vessel diameter (RVD) included between 2.5 and 4.0 mm (by visual estimate) * signed informed consent.
Exclusion criteria
* Myocardial Infarction within the previous 7 days * documented left ventricular ejection fraction \<25% * impaired renal function (creatinine \>3.0 mg/dl) at the time of treatment * outflow obstruction of the graft due to distal anastomotic stenosis * totally occluded Saphenous Vein Graft * brachytherapy treatment in the index vessel before enrollment * life expectancy less than 12 months * known allergy to aspirin, clopidogrel bisulfate, heparin, stainless steel, contrast agent or sirolimus * hemorrhagic diatheses * a recent positive pregnancy test, breast-feeding, or the possibility of a future pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late loss | — |
Secondary
| Measure | Time frame |
|---|---|
| binary angiographic in-stent restenosis | — |
| binary angiographic in-segment restenosis | — |
| intravascular-ultrasound-measured neo-intimal hyperplasia volume | — |
| death | — |
| in-segment late loss | — |
| target-lesion revascularization | — |
| target-vessel revascularization | — |
| stent thrombosis | — |
| myocardial infarction | — |
Countries
Belgium
Outcome results
None listed