ESAR vs FEVAR for Abdominal Aortic Aneurysm

(SOCRATES Trial)

Recruiting at 32 trial locations

Overseen By Sarah Litterscheid, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: FCRE (Foundation for Cardiovascular Research and Education)

Must not be taking: Anticoagulants, Antiplatelets, Contrast media

Disqualifiers: Concurrent study, Life expectancy <2 years, Pregnancy, eGFR <30, MI or CVA <3 months, Connective tissue disease, Prior aneurysm treatment, Emergent treatment, Hypersensitivity to implant, Suprarenal aneurysm, Thrombus >50%, Renal stenosis >50%, Active infection, History of COVID-19, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Index procedure

204 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, you may not be eligible for the trial.

What data supports the effectiveness of the ESAR and FEVAR treatments for Abdominal Aortic Aneurysm?

Research shows that using EndoAnchors in ESAR can help prevent or fix problems during aneurysm repair, and FEVAR is effective for treating complex aneurysms by extending the repair to healthier parts of the aorta. Both treatments have shown good mid-term outcomes in managing abdominal aortic aneurysms. ^{1 2 3 4 5}

How does the ESAR treatment differ from other treatments for abdominal aortic aneurysm?

The ESAR treatment is unique because it combines an endograft with Heli-FX Endoanchors, which provide additional support to secure the graft in place, making it suitable for patients with short neck abdominal aortic aneurysms. In contrast, FEVAR uses a fenestrated endograft that allows for a customized fit around the arteries near the aneurysm, making it effective for complex cases where the aneurysm is close to the renal arteries. ^{1 3 5 6 7}

What is the purpose of this trial?

The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).

Research Team

Giovanni Torsello, Prof. Dr.

Principal Investigator

Vascupedia

Brant Ullery, MD, MBA

Principal Investigator

Medical Director, Vascular Surgery Providence Heart and Vascular Institute

Eligibility Criteria

This trial is for adults over 18 with aortic aneurysms who can follow the study plan and have given consent. They must have specific measurements in their aorta (4-15mm neck length, at least 8mm sealing zone) that don't fit standard treatment and an infrarenal neck angle of ≤45°.

Inclusion Criteria

Infrarenal neck angulation less than or equal to 45°

Subject has provided written informed consent

Subject meets the anatomical requirements according to the locally applicable Endurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo Fenestrated Anaconda (available in EU only), and/or Cook Zenith Fenestrated Graft Instructions for Use

Exclusion Criteria

Subject has a life expectancy less than 2 years

Subject has a known hypersensitivity or allergies to study device implant material

Subject is participating in a concurrent study which may confound study results

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EndoVascular Aneurysm Repair with ESAR or FEVAR for the treatment of aortic aneurysms

Index procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including freedom from endoleaks and secondary interventions

36 months

Regular follow-up visits at 1, 12, 24, and 36 months

Treatment Details

Interventions

• ESAR treatment: Endograft + Heli-FX Endoanchor
• FEVAR treatment : Fenestrated endograft

Trial Overview The SOCRATES trial is testing two types of endograft treatments for aortic aneurysms: ESAR (Endurant + Heli-FX EndoAnchor system) versus FEVAR (customizable grafts from Cook or Terumo). It aims to see which is safer and performs better for short-necked aneurysms.

Participant Groups

Group I: ESAR Experimental Treatment 1 Intervention

Endovascular Aneurysm Repair + Heli-FX EndoAnchors

Group II: FEVAR Active Control 1 Intervention

Fenestrated EndoVascular Aneurysm Repair

Who Is Running the Clinical Trial?

FCRE (Foundation for Cardiovascular Research and Education)

Lead Sponsor

Trials

7

Recruited

1,300+

Prof. Giovanni Torsello

Lead Sponsor

Trials

7

Recruited

700+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

EndoSuture aneurysm repair (ESAR) demonstrated a 100% technical success rate and no major postoperative complications, making it a safe option for treating short neck abdominal aortic aneurysms (AAA).

In terms of midterm outcomes, ESAR showed similar effectiveness to fenestrated endovascular aneurysm repair (FEVAR) regarding aneurysm shrinkage and the absence of type Ia endoleaks, suggesting it is a viable alternative when technical challenges arise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EndoSuture aneurysm repair versus fenestrated aneurysm repair in patients with short neck abdominal aortic aneurysm. Bordet, M., Oliny, A., Miasumu, T., et al.[2023]

In a study of 221 patients undergoing EndoSutured-aneurysm-repair (ESAR) with adjunct Heli-FX EndoAnchors, the procedure achieved a high technical success rate of 96.8% and a freedom from type Ia endoleaks of 94% at two years, indicating its efficacy in preventing complications during endovascular aneurysm repair.

The use of EndoAnchors showed positive trends in sac size reduction, with 92.2% of patients experiencing stable or regressed sac sizes after at least six months of follow-up, suggesting that this technique may be particularly beneficial for patients with challenging anatomical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry. Reyes Valdivia, A., Chaudhuri, A., Milner, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

EndoSuture aneurysm repair versus fenestrated aneurysm repair in patients with short neck abdominal aortic aneurysm. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Endovascular aortic repair with EndoAnchors demonstrate good mid-term outcomes in physician-initiated multicenter analysis-The PERU registry. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Rescue of failed endovascular aortic aneurysm repair using the fenestrated Anaconda device. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Early and Mid-term Efficacy of Fenestrated Endograft in the Treatment of Juxta-Renal Aortic Aneurysms. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

30-Day Readmission and Outcomes after Fenestrated Versus Traditional Endovascular Aortic Aneurysm Repair. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Procedural and perioperative results in patients treated with fenestrated endovascular aneurysm repair planned by automated software in a physician-sponsored investigational device exemption trial of physician-modified endografts. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Editor's Choice - Comparison of Renal Outcomes in Patients Treated by Zenith&#174; Fenestrated and Zenith&#174; Abdominal Aortic Aneurysm Stent grafts in US Prospective Pivotal Trials. [2018]