RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.
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).
Coronary Artery Disease
Saphenous Vein Graft Disease
Device: sirolimus-eluting stent
Device: bare metal stent
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Phase 2 Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Degenerated Saphenous Vein Grafts|
- In-stent late loss
- in-segment late loss
- binary angiographic in-stent restenosis
- binary angiographic in-segment restenosis
- intravascular-ultrasound-measured neo-intimal hyperplasia volume
- myocardial infarction
- target-lesion revascularization
- target-vessel revascularization
- stent thrombosis
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||December 2005|
|Antwerp Cardiovascular Institute Middelheim|
|Antwerp, Belgium, 2020|
|Principal Investigator:||Paul Vermeersch, MD||Antwerp Cardiovascular Institute Middelheim|
|Study Chair:||Glenn Vanlangenhove, MD, PhD||Antwerp Cardiovascular Institute Middelheim|
|Study Director:||Pierfrancesco Agostoni, MD||Antwerp Cardiovascular Institute Middelheim|