NCT00486226

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 105 (actual)
• Sponsor: Codman & Shurtleff · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Vascular Reconstruction Device	CORDIS ENTERPRISE™ VRD

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-12-01
• Completion: 2013-12-01
• First posted: 2007-06-14
• Last updated: 2018-12-12
• Results posted: 2014-04-21

Locations

1 site across 1 country: Belgium