Abdominal Aortic Aneurysm Without Rupture Clinical Trial
Official title:
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)
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04150653 -
Non-invasive Aortic Aneurysm Tissue Characterization Using Wall Viscoelasticity
|
||
Recruiting |
NCT04894864 -
Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair
|
Phase 4 | |
Enrolling by invitation |
NCT04269447 -
Prospective Aortic Biobank of POP-STAR
|
||
Not yet recruiting |
NCT05575570 -
Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR
|
N/A | |
Not yet recruiting |
NCT05279274 -
ShorT Stay Aneurysm Repair Study
|
||
Recruiting |
NCT05976711 -
New MRI Techniques for Diagnosis and Treatment of Abdominal Aortic Aneurysms
|
||
Completed |
NCT03966521 -
The British Society of Endovascular Therapy ConformabLe EndoVascular Aneurysm Repair Registry
|
||
Completed |
NCT05335642 -
Secondary Intervention and Surveillance After EVAR
|
||
Completed |
NCT05346289 -
Elective Treatment Rates and Surgical Non-eligibility Among Men and Women With Intact Abdominal Aortic Aneurysms
|
||
Completed |
NCT04068714 -
Open Versus Endovascular Repair of Abdominal Aortic Aneurysms
|
||
Not yet recruiting |
NCT06332911 -
Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
|