EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study (EVAS2)
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ClinicalTrials.gov Identifier: NCT03298477 |
Recruitment Status :
Active, not recruiting
First Posted : October 2, 2017
Last Update Posted : October 1, 2021
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Sponsor:
Endologix
Information provided by (Responsible Party):
Endologix
Tracking Information | |||||||
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First Submitted Date ICMJE | September 27, 2017 | ||||||
First Posted Date ICMJE | October 2, 2017 | ||||||
Last Update Posted Date | October 1, 2021 | ||||||
Actual Study Start Date ICMJE | December 1, 2017 | ||||||
Estimated Primary Completion Date | August 17, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study | ||||||
Official Title ICMJE | Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study (EVAS 2 Confirmatory IDE Study) | ||||||
Brief Summary | Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System. | ||||||
Detailed Description | This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess safety and effectiveness outcomes. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System. Sites have been chosen with a suitable research infrastructure and physician experience in endovascular aneurysm repair to ensure adequate enrollment. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment). Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Abdominal Aortic Aneurysm Without Rupture | ||||||
Intervention ICMJE | Device: Nellix® System
Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
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Study Arms ICMJE | Single Arm
Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System
Intervention: Device: Nellix® System
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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 | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
98 | ||||||
Original Estimated Enrollment ICMJE |
90 | ||||||
Estimated Study Completion Date ICMJE | August 16, 2025 | ||||||
Estimated Primary Completion Date | August 17, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | INCLUSION CRITERIA A patient who meets all of the following criteria potentially may be included in the study:
EXCLUSION CRITERIA A patient who meets none of the following criteria potentially may be included in the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
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 | NCT03298477 | ||||||
Other Study ID Numbers ICMJE | CP-0008 EVAS2 IDE | ||||||
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 | Endologix | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Endologix | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Endologix | ||||||
Verification Date | September 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |