The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System (SUNRISE)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The SUNRISE Registry - A Multicenter Post-Market Surveillance With the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System|
- The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE) [ Time Frame: Start of the procedure to end of the procedure (defined as removal of catheter sheath introducer after the coiling procedure) ] [ Designated as safety issue: Yes ]
Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency.
Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
- Device or Procedure Related Adverse Events (AEs) [ Time Frame: index procedure to discharge; an average of 3.8 days ] [ Designated as safety issue: Yes ]Incidence of device or procedure related adverse events during the index procedure and till discharge
- Satisfactory Coil Mass Position [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
- Aneurysm Occlusion [ Time Frame: post procedure to 6 months ] [ Designated as safety issue: Yes ]Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)
|Study Start Date:||June 2007|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: 1 Endovascular
All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device.
Device: Vascular Reconstruction Device
CORDIS ENTERPRISE™ VRD
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486226
|Université Libre de Bruxelles|
|Bruxelles, Belgium, 1070|
|Principal Investigator:||Bendszus Martin, MD||Wuerzburg University Hospital|
|Principal Investigator:||Boris Lubicz, MD||Université Libre de Bruxelles|