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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

Tracking Information
First Submitted Date  ICMJE August 1, 2019
First Posted Date  ICMJE August 15, 2019
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE July 17, 2019
Estimated Primary Completion Date July 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Citadel Feasibility Study
Official Title  ICMJE The Citadel Embolization Device Feasibility Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Unruptured Wide-neck Aneurysms
Intervention  ICMJE Device: Citadel Embolization Device
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Study Arms  ICMJE Citadel Embolization Device
The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
Intervention: Device: Citadel Embolization Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 12, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 17, 2021
Estimated Primary Completion Date July 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04057352
Other Study ID Numbers  ICMJE CDM10001448
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stryker Neurovascular
Study Sponsor  ICMJE Stryker Neurovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stryker Neurovascular
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP