EVAR vs ESAR for Abdominal Aortic Aneurysm

(HERCULES Trial)

Recruiting at26 trial locations

Overseen by K. Donas, Prof. Dr.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rijnstate Hospital

Disqualifiers: CVA, MI, Coagulopathy, Infection, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares two methods of repairing abdominal aortic aneurysms in patients with wide aortic necks. One method uses a stent graft alone, while the other adds extra anchors to secure the graft. The goal is to see which method works better for these patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for abdominal aortic aneurysm?

Research shows that using the Heli-FX EndoAnchor system with the Endurant stent graft is effective and safe for treating abdominal aortic aneurysms, especially in challenging cases with short necks, over a period of five years. ^{1 2 3 4 5}

Is the use of the Heli-FX EndoAnchor System and Endurant stent graft safe for treating abdominal aortic aneurysms?

The Heli-FX EndoAnchor System and Endurant stent graft have been shown to be safe for treating abdominal aortic aneurysms, including challenging cases with short necks, over a period of up to five years. ^{1 2 3 4 5}

How is the ESAR treatment for abdominal aortic aneurysm different from other treatments?

The ESAR treatment is unique because it uses the Heli-FX EndoAnchor system to secure the stent graft, which helps prevent complications like leaks and migration, especially in patients with challenging aortic anatomies such as short necks. This approach enhances the stability and effectiveness of the endovascular repair compared to traditional methods. ^{1 2 3 4 6}

Research Team

MMPJ Reijnen, Prof. Dr.

Principal Investigator

Rijnstate, Arnhem, the Netherlands

K. Donas, Prof. Dr.

Principal Investigator

Asklepios Clinic Langen, Langen, Germany

Eligibility Criteria

This trial is for adults with abdominal aortic aneurysms that have a neck diameter of 28-32mm and are at least 10mm long. Candidates must need elective repair, fit the device guidelines, and not have had recent severe cardiovascular events or other conditions that could affect results or increase risks.

Inclusion Criteria

I am 18 years old or older.

Provided written informed consent

I am choosing to have surgery that is not urgent.

Exclusion Criteria

The doctor thinks the patient may live for less than 2 years.

You are planning to use a specific medical device called AUI main body device.

My kidney function is low, with an eGFR below 30.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the index procedure using either the Endurant II/IIs stent graft system alone or in conjunction with Heli-FX EndoAnchors

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness with assessments at 1 month and annually for up to 5 years post-index procedure

5 years

Annual visits (in-person)

Treatment Details

Interventions

• endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system (Endovascular Repair)
• endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system (Endovascular Repair)
• endovascular sealing aneurysm repair (ESAR) using Heli-FX EndoAnchor system (Endovascular Repair)

Trial Overview The HERCULES trial compares two procedures for repairing infrarenal abdominal aortic aneurysms: EVAR using Endurant II/IIs stent grafts versus ESAR with Heli-FX EndoAnchor system. It's randomized, meaning patients are put into groups by chance to test which method works better.

Participant Groups

Group I: Standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system Active Control 1 Intervention

Group II: Endosuture aneurysm repair (ESAR) with the Endurant II/IIs in conjunction with Endoanchors Active Control 1 Intervention

Who Is Running the Clinical Trial?

Rijnstate Hospital

Lead Sponsor

Trials

195

Recruited

77,700+

Desiree van den Hondel

Rijnstate Hospital

Chief Medical Officer

MD from University of Amsterdam

Geraline Leusink

Rijnstate Hospital

Chief Executive Officer

MD from Radboud University Nijmegen

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

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]

In a study of 90 patients with ruptured abdominal aortic aneurysms (RAAAs), it was found that nearly 40% were initially unsuitable for endovascular aneurysm repair (EVAR) due to neck length issues, specifically necks shorter than 10 mm.

The use of Heli-FX EndoAnchors could significantly expand the eligibility for EVAR from 38.9% to 56.7% without correcting iliac deficiencies, and up to 75.6% if iliac issues are addressed, indicating a substantial potential benefit for RAAA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded Suitability of Ruptured Abdominal Aortic Aneurysms for Total Endovascular Repair Using the Endurant Endograft and Heli-FX EndoAnchors. Reyes Valdivia, A., Álvarez Marcos, F., Duque Santos, Á., et al.[2020]

In a study of 70 patients with short-neck abdominal aortic aneurysms (AAA), the Endurant II/IIs endograft combined with Heli-FX EndoAnchors achieved a high procedural success rate of 97.1% and a technical success rate of 88.6%.

The treatment demonstrated a low incidence of type IA endoleaks, with most resolving spontaneously, and no patients experienced serious complications like stent migration or aneurysm rupture within 12 months, indicating that this method is both safe and effective for challenging AAA anatomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. Arko, FR., Stanley, GA., Pearce, BJ., et al.[2020]

The Heli-FX EndoAnchor System, used in endosuture aneurysm repair (ESAR), demonstrated promising 5-year outcomes for patients with short aortic necks, showing a 90.1% freedom from aneurysm-related mortality and 76.9% freedom from any secondary procedures.

Despite some cases of type IA endoleaks, most resolved spontaneously, and there were no device migrations reported, indicating the safety and efficacy of the EndoAnchor system in managing challenging aortic anatomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year outcomes of endosuture aneurysm repair in patients with short neck abdominal aortic aneurysm from the ANCHOR registry. Arko, FR., Pearce, BJ., Henretta, JP., et al.[2023]

The Heli-FX EndoAnchors combined with the Endurant II stent graft have been FDA-approved for treating juxtarenal abdominal aortic aneurysms with short necks (≤4 mm).

This study presents two successful cases of using this endosuture technique for repairing ruptured juxtarenal abdominal aortic aneurysms, indicating its potential effectiveness in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruptured juxtarenal abdominal aortic aneurysm managed with endosuture aneurysm repair. Lopez, S., Pillai, L., Inkollu, S.[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]

References

1. 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]

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

Expanded Suitability of Ruptured Abdominal Aortic Aneurysms for Total Endovascular Repair Using the Endurant Endograft and Heli-FX EndoAnchors. [2020]

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

Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. [2020]

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

Five-year outcomes of endosuture aneurysm repair in patients with short neck abdominal aortic aneurysm from the ANCHOR registry. [2023]

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

Ruptured juxtarenal abdominal aortic aneurysm managed with endosuture aneurysm repair. [2022]

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

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