Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263263
Status:
COMPLETED
Last Update Posted:
2007-03-14
First Post:
2005-12-07
Brief Title:
RRISC Study Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent
Sponsor:
Antwerp Cardiovascular Institute Middelheim
Organization:
Antwerp Cardiovascular Institute Middelheim
Study Overview
Official Title:
Phase 2 Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Degenerated Saphenous Vein Grafts
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None