Clinical trial NCT00486226: The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
Official title: The SUNRISE Registry - A Multicenter Post-Market Surveillance With the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2007-06-14
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering of an intracranial aneurysm and necessitating an endovascular treatment.

Patients who meet all of the general inclusion criteria and none of the exclusion criteria and who agree to voluntarily sign a informed consent form will be enrolled into the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)
timeFrame: Intra-procedure
Secondary outcomes:
measure: Device or Procedure Related Adverse Events (AEs)
timeFrame: index procedure to discharge; an average of 3.8 days
measure: Satisfactory Coil Mass Position
timeFrame: 6 months
measure: Aneurysm Occlusion
timeFrame: post procedure to 6 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Université Libre de Bruxelles
Study officials:
affiliation: Wuerzburg University Hospital
name: Bendszus Martin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Libre de Bruxelles
name: Boris Lubicz, MD
role: PRINCIPAL_INVESTIGATOR
References: