Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices

This trial is a prospective, randomized, multi-center trial, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The trial is designed to compare the anatomically stabilized AFX Endograft System to a reference group of proximally fixated EVAR devices. Patients will be randomized between the two groups.

Randomization will be 1:1. Each investigator will select one comparator device of their choice before enrolling the first patient. The study will sequentially evaluate non-inferiority and superiority hypotheses.

Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this study.

• AFX EVAR AAA Graft System (Device): Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
• FDA Approved EVAR AAA Graft Systems (Device)

Primary outcomes

• Number of Patients With Absence of Aneurysm Related Complications (ARC) [1 year]: ARC is a composite of the most relevant EVAR outcomes and includes: * Peri-Operative Death (< 30 days) * Rupture * Conversion to OSR * Endoleaks; post-operative * Migration (≥ 10mm) * Aneurysm Enlargement (≥ 5mm) * Endograft Limb Occlusions * Reinterventions for device- or aneurysm-related complications

Secondary outcomes

• The Number of MAEs [At 30 days, 12 months, and annually up to five years]: Major Adverse Events
• The Number of Participants With Aneurysm Related Complications (ARC) [Post 12 Months up to Five Years]: ARC is a composite outcome
• The Number of Participants With Aneurysm Related Mortality [Up to Five Years]: Death related to the aneurysm
• Number of Type Ia Endoleaks [Up to Five Years]: Number of participants with Type Ia endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ia endoleak defined as persistent leak around the top of the stent graft identified during imaging surveillance at the different timepoints.
• Number of Type Ib Endoleaks [Up to Five Years]: Number of participants with Type Ib endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ib endoleak defined as persistent leak around the bottom of the stent graft identified during imaging surveillance at the different timepoints.
• Number Endoleaks Type II [Up to Five Years]: Number of participants with Type II endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type II endoleak defined as persistent blood flow into the aneurysm sac from branches of the aorta identified during imaging surveillance at the different timepoints.
• Number of Endoleaks Type IIIa [Up to Five Years]: Number of participants with Type IIIa endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIa endoleak defined as persistent leak from the overlapping parts of the stent graft identified during imaging surveillance at the different timepoints.
• Number of Endoleaks Type IIIb [Up to Five Years]: Number of participants with Type IIIb endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIb endoleak defined as persistent leak as a consequence of graft rupture, identified during imaging surveillance at the different timepoints.
• Number of Participants With Aneurysm Rupture [12 Months, 24 Months, 36 Months, 48 Months, 60 Months]: Number of Participants with Aneurysm Rupture at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
• Number of Participants With Open Conversion [12 Months, 24 Months, 36 Months, 48 Months, 60 Months]: Number of Participants that underwent an Open Conversions at 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
• Number of Participants With Aneurysm Expansion [12 Months, 24 Months, 36 Months, 48 Months, 60 Months]: Number of Participants with Aneurysm Expansion at 12 Months, 24 Months, 36 Months, 48 months, 60 Months
• Number of Patients With Endograft Occlusion [12 Months, 24 Months, 36 Months, 48 Months and 60 Months]: Number of Patients with Endograft Occlusion at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
• Number of Participants With Device-Related Secondary Interventions [30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months]: Number of Participants with Device-Related Secondary Interventions at 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
• Number of Patients With Adjunctive Procedures [Intraprocedural]: Number of patients with adjunctive procedure during the implant

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Male or female at least 18 years old
2. Subjects with minimum of 2 year life expectancy
3. Subjects have signed the informed consent document for data release
4. Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.

Exclusion Criteria:

1. Currently participating in another study where primary endpoint has not been reached yet
2. Known allergy to any of the device components
3. Pregnant (females of childbearing potential only)
4. Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR

Participant flow

Outcome results

• Number of Patients With Absence of Aneurysm Related Complications (ARC) (Primary), Count of participants, Participants: AFX EVAR AAA Graft System 195; FDA Approved EVAR AAA Graft Systems 175
• The Number of MAEs (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 3; FDA Approved EVAR AAA Graft Systems 4
• The Number of Participants With Aneurysm Related Complications (ARC) (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 52; FDA Approved EVAR AAA Graft Systems 64
• The Number of Participants With Aneurysm Related Mortality (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 3; FDA Approved EVAR AAA Graft Systems 1
• Number of Type Ia Endoleaks (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 2; FDA Approved EVAR AAA Graft Systems 0
• Number of Type Ib Endoleaks (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 4; FDA Approved EVAR AAA Graft Systems 3
• Number Endoleaks Type II (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 36; FDA Approved EVAR AAA Graft Systems 48
• Number of Endoleaks Type IIIa (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 0; FDA Approved EVAR AAA Graft Systems 0
• Number of Endoleaks Type IIIb (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 0; FDA Approved EVAR AAA Graft Systems 0
• Number of Participants With Aneurysm Rupture (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 0; FDA Approved EVAR AAA Graft Systems 0
• Number of Participants With Open Conversion (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 0; FDA Approved EVAR AAA Graft Systems 3
• Number of Participants With Aneurysm Expansion (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 2; FDA Approved EVAR AAA Graft Systems 4
• Number of Patients With Endograft Occlusion (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 3; FDA Approved EVAR AAA Graft Systems 8
• Number of Participants With Device-Related Secondary Interventions (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 5; FDA Approved EVAR AAA Graft Systems 2
• Number of Patients With Adjunctive Procedures (Secondary), Count of participants, Participants: AFX EVAR AAA Graft System 3; FDA Approved EVAR AAA Graft Systems 1

Adverse events

Time frame: AEs are collected through 5 year follow-up visit.

Serious adverse events by term

Other adverse events by term

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• Volodos' NL, Karpovich IP, Shekhanin VE, Troian VI, Iakovenko LF. [A case of distant transfemoral endoprosthesis of the thoracic artery using a self-fixing synthetic prosthesis in traumatic aneurysm]. Grudn Khir. 1988 Nov-Dec;(6):84-6. No abstract available. Russian. PMID 3220297
• Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8. doi: 10.1016/S0140-6736(04)16979-1. PMID 15351191
• Brown LC, Greenhalgh RM, Thompson SG, Powell JT; EVAR Trial Participants. Does EVAR alter the rate of cardiovascular events in patients with abdominal aortic aneurysm considered unfit for open repair? Results from the randomised EVAR trial 2. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):396-402. doi: 10.1016/j.ejvs.2010.01.002. Epub 2010 Jan 21. PMID 20096611
• Stroupe KT, Lederle FA, Matsumura JS, Kyriakides TC, Jonk YC, Ge L, Freischlag JA; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Cost-effectiveness of open versus endovascular repair of abdominal aortic aneurysm in the OVER trial. J Vasc Surg. 2012 Oct;56(4):901-9.e2. doi: 10.1016/j.jvs.2012.01.086. Epub 2012 May 27. PMID 22640466
• De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9. doi: 10.1056/NEJMoa0909499. PMID 20484396
• Results publication: Kwolek CJ, Ouriel K, Stucky FS, Rao VK, Pons PJ, Wilson SE, Kujath SW. Five-year results of the LEOPARD trial of commercially available endografts. J Vasc Surg. 2023 Aug;78(2):324-332.e2. doi: 10.1016/j.jvs.2023.04.011. Epub 2023 Apr 15. PMID 37068528

• Study Protocol and Statistical Analysis Plan (PDF, 2021-08-29)

• Christopher Kwolek, MD, Principal investigator, Endologix