EVAR vs ESAR for Abdominal Aortic Aneurysm

(HERCULES Trial)

Recruiting at 33 trial locations

Overseen By Daphne van der Veen, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rijnstate Hospital

Disqualifiers: CVA, MI, Coagulopathy, Infection, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 month

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for repairing abdominal aortic aneurysms (AAA) in individuals with a specific artery shape. One method is the standard endovascular aneurysm repair (EVAR) using a stent graft, while the other is endosuture aneurysm repair (ESAR), which uses tiny anchors to better secure the graft. The trial aims to determine which method is more effective for individuals whose infrarenal artery is wider than usual (between 28mm and 32mm). Eligible participants have an AAA and a suitable artery shape for these treatments. As an unphased trial, this study provides a unique opportunity to advance medical knowledge and potentially benefit from innovative treatment options.

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 prior data suggests that these aneurysm repair techniques are safe?

Research shows that both endosuture aneurysm repair (ESAR) and endovascular aneurysm repair (EVAR) are well-tolerated by patients. For ESAR, studies indicate that using EndoAnchors with the Endurant stent graft is safe and effective. Patients have experienced good results over several years, suggesting the treatment is reliable with few side effects.

Similarly, EVAR with the Endurant II/IIs stent graft system has demonstrated positive long-term outcomes. Studies report low complication rates and success in reducing aneurysm size. This suggests that the treatment is safe and generally well-received by patients.

Both treatment options have undergone thorough study, and evidence supports their safety for treating abdominal aortic aneurysms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for abdominal aortic aneurysm because they offer innovative approaches to enhancing durability and stability. While traditional endovascular aneurysm repair (EVAR) focuses on using stent grafts, endosuture aneurysm repair (ESAR) incorporates the Heli-FX EndoAnchor system. This system acts like a seatbelt, providing additional anchoring to prevent stent graft movement or leaks. The use of EndoAnchors aims to improve long-term outcomes by reducing the risk of complications, which could mean fewer follow-up surgeries and increased safety for patients.

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

This trial will compare two treatment approaches for abdominal aortic aneurysms: endosuture aneurysm repair (ESAR) using the Heli-FX EndoAnchor system and standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system. Research has shown that the Heli-FX EndoAnchor system in ESAR can enhance the stability and security of the connection between the aorta and the stent graft. Five-year results from the ANCHOR registry indicated positive outcomes for patients, particularly those with short-neck aortic aneurysms. Similarly, studies on EVAR with the Endurant II/IIs stent graft system have shown promising results. After ten years, 64.1% of patients experienced a reduction in the size of their aneurysm sac, suggesting effective treatment. Both ESAR and EVAR have proven effective in treating infrarenal abdominal aortic aneurysms (AAA), with ESAR providing additional benefits in securing the stent graft. ^{1 2 4 6 7}

Who Is on the Research Team?

MMPJ Reijnen, Prof. Dr.

Principal Investigator

Rijnstate, Arnhem, the Netherlands

K. Donas, Prof. Dr.

Principal Investigator

Asklepios Clinic Langen, Langen, Germany

Are You a Good Fit for This Trial?

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

Provided written informed consent

I am choosing to have surgery that is not urgent.

The part of my aorta just above my kidneys is between 28 and 32 mm wide.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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

endosuture aneurysm repair (ESAR) using Heli-FX EndoAnchor system is already approved in United States, European Union for the following indications:

Approved in United States as Heli-FX EndoAnchor System for:

• Infrarenal abdominal aortic aneurysms (AAAs) with wide proximal neck diameters (≥ 28mm and ≤ 32mm)
• Short-neck anatomy (4-10 mm)

Approved in European Union as Heli-FX EndoAnchor System for:

• Infrarenal abdominal aortic aneurysms (AAAs) with wide proximal neck diameters (≥ 28mm and ≤ 32mm)
• Short-neck anatomy (4-10 mm)

Who Is Running the Clinical Trial?

Rijnstate Hospital

Lead Sponsor

Trials

195

Recruited

77,700+

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

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]

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 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]

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]

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. 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.

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

Endosuture aneurysm repair in patients treated with ... Clinical data have demonstrated the ability of EndoAnchor implants to improve fixation and seal between the native aorta and an aortic stent graft in both short ...

3. 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 ...

4. 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.

5. 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 ...

6. 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.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30850297/

Endosuture aneurysm repair in patients treated with ... This study sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa ...