Coronary Artery Disease Clinical Trial
Official title:
Phase 2 Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Degenerated Saphenous Vein Grafts
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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