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

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

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Vascular Reconstruction Device

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.

• Study Type: Observational
• Enrollment (Actual): 105

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Université libre de Bruxelles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1 Endovascular; All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device.	Device: Vascular Reconstruction Device; CORDIS ENTERPRISE™ VRD; Other Names: ENTERPRISE; Codman ENTERPRISE; Codman VRD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Codman & Shurtleff
• Investigators: Principal Investigator: Bendszus Martin, MD, Wuerzburg University Hospital; Principal Investigator: Boris Lubicz, MD, Université libre de Bruxelles

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2007
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 13, 2007
• First Submitted That Met QC Criteria: June 13, 2007
• First Posted (Estimate): June 14, 2007

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: EN07-01