EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

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.

• Nellix® System (Device): Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 18 Years to any

INCLUSION CRITERIA

A patient who meets all of the following criteria potentially may be included in the study:

1. Male or female at least 18 years old;
2. Informed consent form understood and signed
3. Patient agrees to all follow-up visits;
4. Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.
5. Anatomically eligible for the Nellix System (per Instructions For Use):

   1. Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
   2. Aneurysm blood lumen diameter ≤60mm;
   3. Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;
   4. Most caudal renal artery to each hypogastric artery length ≥100mm;
   5. Common iliac artery lumen diameter between 9 and 35mm;
   6. Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm;
   7. Ability to preserve at least one hypogastric artery.
   8. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.40

EXCLUSION CRITERIA

A patient who meets none of the following criteria potentially may be included in the study:

1. Life expectancy <2 years as judged by the Investigator;
2. Psychiatric or other condition that may interfere with the study;
3. Participating in another clinical study;
4. Known allergy or contraindication to any device material;
5. Coagulopathy or uncontrolled bleeding disorder;
6. Ruptured, leaking or mycotic aneurysm;
7. Serum creatinine (S-Cr) level >2.0 mg/dL;
8. CVA or MI within three months of enrollment/treatment;
9. Aneurysmal disease of the descending thoracic aorta;
10. Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);
11. Connective tissue diseases (e.g., Marfan Syndrome);
12. Unsuitable vascular anatomy that may interfere with device introduction or deployment;
13. Pregnant (female of childbearing potential only).

Participant flow

Outcome results

• Safety: Major Adverse Events (MAE) (Primary), Number, Number of Events: Nellix System 1
• Effectiveness: Rate of Treatment Success (Primary), Number, percentage of treatment success: Nellix System 92.2
• Conversions, Death and Ruptures (Secondary), Number, Number of Events: Nellix EndoVascular Aneurysm Sealing System 0
• Device Integrity (Secondary), Number, Number of Events: Nellix EndoVascular Aneurysm Sealing System: 5
• Device Performance - Endoleak (Secondary), Count of participants, Participants: Single Arm Nellix EndoVascular Aneurysm Sealing System 5
• DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size (Secondary), Mean, mm: Nellix System 55.4 +/- 5.9
• DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month (Secondary), Number, Number of subjects: Nellix System 3
• Secondary Interventions (Secondary), Number, Number of Events: Nellix System 0
• LABS-RENAL FUNCTION (EGFR) (Secondary), Mean, mL/min/1.73 m^2: Nellix System 66 +/- 24
• LABS- RENAL FUNCTION (CREATININE) (Secondary), Mean, mg/dL: Nellix System 1.19 +/- 0.42

Adverse events

Time frame: All Adverse Events data occurring during the study period were collected (i.e. procedure through 5 years follow-up). The data reported here are as of the data cut for 2-year primary endpoint data.

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2020-03-30)
• Informed Consent Form (PDF, 2020-08-07)

• Jeffrey Carpenter, MD, Principal investigator, Cooper Hospital