EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study
- Conditions
- Abdominal Aortic Aneurysm Without Rupture
- Registration Number
- NCT03298477
- Lead Sponsor
- Endologix
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 98
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety: Major Adverse Events (MAE) 30 days The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, defined as the composite of the following All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Renal Failure; Respiratory Failure; Stroke; Procedural Blood Loss ≥1,000cc
Effectiveness: Rate of Treatment Success 2 year The primary effectiveness endpoint is defined as the rate of Treatment Success at year 2. Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of infrarenal AAA as follows:
It is defined as procedural technical success and absence of Abdominal aortic aneurysm rupture; Conversion to open surgical repair; Endoleak Type I or III at year 2; Clinically significant migration; \> 5mm aneurysm sac enlargement of the maximal diameter as measured by the difference from the 30-Day CT time point; or Secondary endovascular procedure up to year 2 for resolution of Endoleak (Type I or Type III), Device obstruction or occlusion, Device migration, Abdominal aneurysm sac expansion, Device defect.
- Secondary Outcome Measures
Name Time Method Conversions, Death and Ruptures 2 Years Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023,
Device Integrity 2 Years Device Integrity is defined as the absence of device fracture, stenosis, kink, occlusion, or migration \>5mm. All incidences of stent occlusion (100% device lumen obstruction) are also captured as stent stenosis (\<100% device lumen obstruction).
Device Performance - Endoleak 2 Years Demonstrates device performance as indicated by the incidence of Endoleaks through study follow-up. Endoleak is determined by the CoreLab based on imaging completed. Endoleak is defined as clear evidence of contrast outside of one or both EndoBags which communicates with the aneurysm sac originating proximally at the infrarenal segment (Type IA), distally (Type IB); between components, if an extender is used (Type III); trans-device (Type IV); or from a patent collateral vessel (Type II: e.g., lumbar artery; inferior mesenteric artery).
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size 2 years Average Sac Diameter size at Visit
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month 2 Years Number of subjects that had changes in the Sac Diameter size since the 1 month follow-up visit
Secondary Interventions 2 Years All Secondary interventions reported during the study
LABS-RENAL FUNCTION (EGFR) 2 Years The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit
LABS- RENAL FUNCTION (CREATININE) 2 Years Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit
Trial Locations
- Locations (27)
Valley Vascular Consultants
🇺🇸Huntsville, Alabama, United States
Regents of the University of California (UCLA)
🇺🇸Los Angeles, California, United States
Veterans Medical Research Foundation
🇺🇸San Diego, California, United States
UC Health-Memorial Hospital
🇺🇸Colorado Springs, Colorado, United States
MedStar Health Research Institute
🇺🇸Washington, District of Columbia, United States
Miami Cardiac & Vascular Institute (MCVI)
🇺🇸Miami, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Coastal Vascular & Interventional
🇺🇸Pensacola, Florida, United States
Christie Clinic
🇺🇸Champaign, Illinois, United States
AMITA Health
🇺🇸Elk Grove Village, Illinois, United States
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