NCT00263263

RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.

Phase 2 Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Degenerated Saphenous Vein Grafts

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (planned)
• Sponsor: Antwerp Cardiovascular Institute Middelheim · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Stable Angina
• Unstable Angina
• Coronary Artery Disease
• Saphenous Vein Graft Disease

Interventions

Type	Name	Description
DEVICE	sirolimus-eluting stent
DEVICE	bare metal stent

Timeline

• Start date: 2003-09-01
• Completion: 2005-12-01
• First posted: 2005-12-08
• Last updated: 2007-03-14

Locations

1 site across 1 country: Belgium