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OpenTrials
Completed

NCT Number: NCT00486226

The Registry to Study Safety and Performance of the CORDIS 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Université Libre de Bruxelles

Brussels, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vascular Reconstruction Device

Device

CORDIS ENTERPRISE™ VRD

Other names: ENTERPRISE, Codman ENTERPRISE, Codman VRD

Primary outcomes

  1. 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: Intra-procedure

    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 outcomes

  1. Device or Procedure Related Adverse Events (AEs)

    Time frame: index procedure to discharge; an average of 3.8 days

    Incidence of device or procedure related adverse events during the index procedure and till discharge

  2. Satisfactory Coil Mass Position

    Time frame: 6 months

    Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically

  3. Aneurysm Occlusion

    Time frame: post procedure to 6 months

    Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)

Sponsors and collaborators

Lead sponsor

Codman & Shurtleff

Industry

Registry information

Official study title

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

Acronym: SUNRISE

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Jun 14, 2007
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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