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Citadel Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04057352
Recruitment Status : Enrolling by invitation
First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular

Brief Summary:
The purpose of this feasibility study is to gather preliminary safety and effectiveness data on Citadel Embolization Device in the treatment of wide-neck intracranial aneurysms.

Condition or disease Intervention/treatment Phase
Unruptured Wide-neck Aneurysms Device: Citadel Embolization Device Not Applicable

Detailed Description:
In this feasibility study, use of the Citadel Embolization Device will be limited to a population of patients with unruptured wide-neck aneurysms who meet all study eligibility criteria. The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: The Citadel Embolization Device Feasibility Study
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : July 17, 2020
Estimated Study Completion Date : July 17, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Citadel Embolization Device
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Device: Citadel Embolization Device
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.




Primary Outcome Measures :
  1. Procedural Outcome [ Time Frame: Time of Index Procedure ]
    Primary Procedural Outcome Measure of the study is successful Citadel Embolization Device deployment to the target aneurysm.


Secondary Outcome Measures :
  1. Safety Endpoint [ Time Frame: 12 month post-procedure ]
    A safety endpoint is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery, occurring within 12 months post-procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. Has a single, unruptured target intracranial aneurysm that is suitable for endovascular treatment.

Exclusion Criteria:

1. Target aneurysm has been previously treated


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057352


Locations
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United States, West Virginia
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Stryker Neurovascular

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Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT04057352     History of Changes
Other Study ID Numbers: CDM10001448
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases