ESAR vs FEVAR for Abdominal Aortic Aneurysm

(SOCRATES Trial)

Recruiting at 36 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for abdominal aortic aneurysms, a condition where part of the aorta balloons out. One treatment, ESAR (Endovascular Sealing with Anchors and Reinforcement), uses a special anchor system called the Heli-FX Endoanchor to secure the repair. The other treatment, FEVAR (Fenestrated Endovascular Aneurysm Repair), employs customizable grafts to fit the patient's unique anatomy. The trial compares these methods to determine which is safer and more effective. Suitable candidates are those with an aortic aneurysm that standard methods cannot repair due to the aorta's shape. As an unphased trial, this study allows patients to contribute to innovative research that could improve treatment options for complex aneurysms.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, researchers examined the safety of the ESAR treatment, which uses the Endurant endograft with Heli-FX EndoAnchors. The results showed that this treatment is generally safe, with patients experiencing good outcomes over five years. It is well-tolerated, as most people did not encounter major problems after the procedure.

For the FEVAR treatment, which uses fenestrated endografts, research has also shown it to be safe. Long-term results indicate that patients had good outcomes, and the treatment was considered a safe option for those with difficult aneurysms.

Both treatments have undergone extensive study. While some risks exist, as with any medical procedure, these treatments have demonstrated promising safety records in research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

ESAR treatment is unique because it combines an endograft with Heli-FX EndoAnchors, offering enhanced stability and fixation for abdominal aortic aneurysms. This is particularly important compared to traditional endovascular aneurysm repair (EVAR), which might not ensure the same level of anchoring in complex anatomies. Researchers are excited about the potential for ESAR to reduce complications like endoleaks, which are a common concern with current treatments. On the other hand, FEVAR employs a fenestrated endograft, allowing for a customized fit that can accommodate aneurysms near critical blood vessels, which standard grafts might not effectively address. This innovation could lead to improved outcomes for patients with challenging aneurysm locations.

What evidence suggests that this trial's treatments could be effective for aortic aneurysms?

This trial will compare ESAR and FEVAR treatments for abdominal aortic aneurysms. Research has shown that both treatments are promising. Participants in the ESAR arm will receive the Endograft with Heli-FX EndoAnchor system, which studies have found to have a 97.1% success rate, providing stability to the repair. Participants in the FEVAR arm will receive the Fenestrated EndoVascular Aneurysm Repair, which has shown strong results in long-term studies, maintaining open and well-functioning blood vessels. More than 80% of patients have seen their aneurysms shrink with FEVAR, indicating its effectiveness. Both treatments have been thoroughly studied and offer effective solutions for managing aortic aneurysms. ^{1 2 3 5 6}

Who Is on the Research Team?

Brant Ullery, MD, MBA

Principal Investigator

Medical Director, Vascular Surgery Providence Heart and Vascular Institute

Giovanni Torsello, Prof. Dr.

Principal Investigator

Vascupedia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37558144/

Five-year outcomes of endosuture aneurysm repair in ... This study reports the 5-year patient outcomes of the Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry (ANCHOR) short neck regulatory ...

2. jvascsurg.org jvascsurg.org/article/S0741-5214(23)01733-0/fulltext

Five-year outcomes of endosuture aneurysm repair in ... This study reports the 5-year patient outcomes of the Aneurysm Treatment using the Heli-FX EndoAnchor System Global Registry (ANCHOR) short neck regulatory ...

3. medtronic.com medtronic.com/me-en/healthcare-professionals/products/cardiovascular/aortic-stent-grafts/heli-fx-endoanchor/clinical-outcomes.html

Clinical Outcomes Heli-FX™ EndoAnchor™ System View clinical data for the Heli-FX EndoAnchor system used in endovascular aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR) procedures.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0741521419300680

Endosuture aneurysm repair in patients treated with ... Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The duration of the implant procedure, EndoAnchor ...

5. medtronic.com medtronic.com/en-us/healthcare-professionals/products/cardiovascular/aortic/accessories/heli-fx-endoanchor-system/clinical-evidence.html

Clinical Evidence - Heli-FX™ EndoAnchor™ System Review the results of clinical studies and trials related to the effectiveness of the Heli-FX™ EndoAnchor™ system.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01534819

ANCHOR (Aneurysm Treatment Using the Heli-FX ... Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm.