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

Intracranial Aneurysm Clinical Trial

— SUNRISE  

Official title:

The SUNRISE Registry - A Multicenter Post-Market Surveillance With the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486226
• Other study ID #: EN07-01
• Status: Completed
• Start date: June 1, 2007
• Est. completion date: December 1, 2013

Study information

• Verified date: December 2018
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 1, 2013
• Est. primary completion date: December 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Vascular Reconstruction Device
CORDIS ENTERPRISE™ VRD

Locations

Country	Name	City	State
Belgium	Université Libre de Bruxelles	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intra-procedure
Secondary	Device or Procedure Related Adverse Events (AEs)	Incidence of device or procedure related adverse events during the index procedure and till discharge	index procedure to discharge; an average of 3.8 days
Secondary	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	6 months
Secondary	Aneurysm Occlusion	Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)	post procedure to 6 months