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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00486226
First received: June 13, 2007
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Intracranial Aneurysm
Device: Vascular Reconstruction Device
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The SUNRISE Registry - A Multicenter Post-Market Surveillance With the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System

Resource links provided by NLM:


Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:
  • The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE) [ Time Frame: Start of the procedure to end of the procedure (defined as removal of catheter sheath introducer after the coiling procedure) ] [ Designated as safety issue: Yes ]

    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



Secondary Outcome Measures:
  • Device or Procedure Related Adverse Events (AEs) [ Time Frame: index procedure to discharge; an average of 3.8 days ] [ Designated as safety issue: Yes ]
    Incidence of device or procedure related adverse events during the index procedure and till discharge

  • Satisfactory Coil Mass Position [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically

  • Aneurysm Occlusion [ Time Frame: post procedure to 6 months ] [ Designated as safety issue: Yes ]
    Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)


Enrollment: 109
Study Start Date: June 2007
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486226

Locations
Belgium
Université Libre de Bruxelles
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Codman & Shurtleff
Investigators
Principal Investigator: Bendszus Martin, MD Wuerzburg University Hospital
Principal Investigator: Boris Lubicz, MD Université Libre de Bruxelles
  More Information

No publications provided

Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00486226     History of Changes
Other Study ID Numbers: EN07-01
Study First Received: June 13, 2007
Results First Received: January 8, 2014
Last Updated: March 19, 2014
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:
Intracranial Aneurysm
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014