Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180453
Status:
COMPLETED
Last Update Posted:
2010-01-06
First Post:
2005-09-13
Brief Title:
SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
SPIRIT First A Clinical Evaluation of an Investigational Device The Abbott XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
Status:
COMPLETED
Status Verified Date:
2009-06
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:
Prospective randomized controlled single-blinded parallel two-arm multicenter trial
Test arm XIENCE V Everolimus Eluting Coronary Stent Systemstent length 18mm diameter 30mm Control arm Metallic stent MULTI-LINK VISION metallic stentstent length 18mm diameter 30mm Follow-up angiographic imaging and intra vascular ultra sound IVUS at 180 days and 1 year
Test arm XIENCE V Everolimus Eluting Coronary Stent Systemstent length 18mm diameter 30mm Control arm Metallic stent MULTI-LINK VISION metallic stentstent length 18mm diameter 30mm Follow-up angiographic imaging and intra vascular ultra sound IVUS at 180 days and 1 year
Detailed Description:
The SPIRIT FIRST clinical trial will enroll approximately 60 patients and will assess the feasibility and performance of the XIENCE V Everolimus Eluting Coronary Stent System in the treatment of patients with de novo native coronary artery lesions In this trial the XIENCE V Everolimus Eluting Coronary Stent System will be compared to the MULTI-LINK VISION metallic stent which is CE marked and FDA approved and is available for commercial use in Europe and in the United States The SPIRIT FIRST Clinical trial will enroll approximately 60 patients 30 patients in the test arm and 30 patients in the control arm with de novo native coronary artery lesions in 4 clinical sites in The Netherlands and Germany
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