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

Codman & Shurtleff

Status: Completed

Conditions: Intracranial Aneurysm

Treatments: Device: Vascular Reconstruction Device

Study type: Observational

Funder types: Industry

Identifiers

NCT00486226

EN07-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

105 participants in 1 patient group

1 Endovascular

Description:

All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device.

Treatment:

Device: Vascular Reconstruction Device