Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486226
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2007-06-13
Brief Title:
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
Sponsor:
Codman Shurtleff
Organization:
Codman Shurtleff
Study Overview
Official Title:
The SUNRISE Registry - A Multicenter Post-Market Surveillance With the CORDIS ENTERPRISE Vascular Reconstruction Device and Delivery System
Status:
COMPLETED
Status Verified Date:
2018-12
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:
SUNRISE
Brief Summary:
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE Vascular Reconstruction Device and Delivery System VRD to facilitate endovascular coil embolization of intracranial aneurysms
Detailed Description:
The data will be collected in consecutive subjects treated with the commercially available product and following standard clinical practice This registry will be limited to subjects who have received only the CORDIS ENTERPRISE VRD during the index procedure While only limited inclusion or exclusion criteria are specified uniform complete and accurate data will be collected peri-procedurally during the index hospitalization and during follow-up up to 6 months All subjects should be treated according to the Instruction For Use IFU including conduct of the VRD placement coiling procedure application of antiplatelet medication and any other medical therapy to be provided according to local usual practice
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