US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair (NECC)
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04852783 |
Recruitment Status :
Recruiting
First Posted : April 21, 2021
Last Update Posted : April 10, 2024
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Sponsor:
Cerus Endovascular, Ltd
Information provided by (Responsible Party):
Cerus Endovascular, Ltd
Tracking Information | |||||||
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First Submitted Date ICMJE | April 16, 2021 | ||||||
First Posted Date ICMJE | April 21, 2021 | ||||||
Last Update Posted Date | April 10, 2024 | ||||||
Actual Study Start Date ICMJE | August 6, 2021 | ||||||
Estimated Primary Completion Date | July 2025 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Key Secondary Effectiveness Endpoint [ Time Frame: 1 year ] The trial's secondary endpoint is the proportion of subjects with angiographic aneurysmal recurrence defined as aneurysm growth or recanalization at one (1) year after treatment.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair | ||||||
Official Title ICMJE | US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair | ||||||
Brief Summary | The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device. | ||||||
Detailed Description | The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device. This trial is a prospective, multicenter single-arm study. Up to 220 subjects will be enrolled at up to 20 participating investigational sites. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: This trial is a prospective, multicenter single-arm study. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Aneurysm, Intracranial | ||||||
Intervention ICMJE | Device: Contour Neurovascular System
Endovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms.
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Study Arms ICMJE | Not Provided | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
250 | ||||||
Original Estimated Enrollment ICMJE |
220 | ||||||
Estimated Study Completion Date ICMJE | July 2029 | ||||||
Estimated Primary Completion Date | July 2025 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04852783 | ||||||
Other Study ID Numbers ICMJE | DNX102-01 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Cerus Endovascular, Ltd | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Cerus Endovascular, Ltd | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Cerus Endovascular, Ltd | ||||||
Verification Date | April 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |