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

NCT ID: NCT00486226

Last Updated: 2018-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-01

Study Completion Date

2013-12-01

Brief Summary

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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

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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

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Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 Endovascular

All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device.

Vascular Reconstruction Device

Intervention Type DEVICE

CORDIS ENTERPRISE™ VRD

Interventions

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Vascular Reconstruction Device

CORDIS ENTERPRISE™ VRD

Intervention Type DEVICE

Other Intervention Names

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ENTERPRISE Codman ENTERPRISE Codman VRD

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Codman & Shurtleff

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bendszus Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital

Boris Lubicz, MD

Role: PRINCIPAL_INVESTIGATOR

Université Libre de Bruxelles

Locations

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Université Libre de Bruxelles

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EN07-01

Identifier Type: -

Identifier Source: org_study_id