Université Libre de Bruxelles
Brussels, 1070, Belgium
NCT Number: NCT00486226
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.
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Notify Me18 year–80 year
All sexes
Observational
Brussels, 1070, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CORDIS ENTERPRISE™ VRD
Other names: ENTERPRISE, Codman ENTERPRISE, Codman VRD
Time frame: Intra-procedure
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: index procedure to discharge; an average of 3.8 days
Incidence of device or procedure related adverse events during the index procedure and till discharge
Time frame: 6 months
Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
Time frame: post procedure to 6 months
Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)
Codman & Shurtleff
Industry
The SUNRISE Registry - A Multicenter Post-Market Surveillance With the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System
Acronym: SUNRISE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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