The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

The subject must be >= 18 years of age and less than 80 years.
Diagnosis of a ruptured (Hunt and Hess Grade I - III) or unruptured intracranial aneurysm at the time of the treatment
Subject (or his/her legal representative) provides written informed consent for the use of his/her peri-procedural and follow-up data

Exclusion Criteria

Diagnosis of Hunt and Hess Grade IV or V subarachnoid hemorrhage at the time of the treatment
Severe co-morbidity associated with a life-expectancy of less than six months
Poor neurological status at baseline
Known allergies to Nitinol metal
Known allergies to aspirin, heparin, ticlopidine, or clopidogrel or unable or unwilling to tolerate therapy
Participation in an investigational drug or another device study is only allowed after written approval of the coordinating investigator or Cordis Medical Monitor.
Implantation of an intracranial stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
Implantation of carotid stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
Atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.

Arm && Interventions

Group	Intervention	Description
1 Endovascular	Vascular Reconstruction Device	All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device.

Primary Outcome Measures

Name	Time	Method
The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)	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

Secondary Outcome Measures

Name	Time	Method
Device or Procedure Related Adverse Events (AEs)	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
Satisfactory Coil Mass Position	6 months	Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
Aneurysm Occlusion	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)