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.
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 Type
OBSERVATIONAL
Enrollment
105
CORDIS ENTERPRISE™ VRD
Université Libre de Bruxelles
Brussels, Belgium
The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)
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
Time frame: Intra-procedure
Device or Procedure Related Adverse Events (AEs)
Incidence of device or procedure related adverse events during the index procedure and till discharge
Time frame: index procedure to discharge; an average of 3.8 days
Satisfactory Coil Mass Position
Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
Time frame: 6 months
Aneurysm Occlusion
Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)
Time frame: post procedure to 6 months
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