Stent Graft Systems for Abdominal Aortic Aneurysm

(ADVANCE Trial)

Recruiting at 68 trial locations

Overseen By ADVANCE Trial Clinical Study Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Must not be taking: Anticoagulants, Anti-platelets

Disqualifiers: Life expectancy ≤ 3 years, Connective tissue disease, Prior aortic surgery, eGFR < 45, others

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

Compensation: Varies

Number of Visits: 31

Duration: Procedure day

550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather evidence on the effectiveness of two different stent graft systems for individuals with abdominal aortic aneurysms (a bulging and weakened area in the lower part of the aorta). Participants will be randomly assigned to receive either the Endurant Stent Graft System or the Excluder Endoprosthesis, with progress tracked through imaging. The trial seeks individuals with a sizeable abdominal aortic aneurysm, specifically a bulge of at least 5 cm for women or 5.5 cm for men, whose condition is suitable for either stent system. This trial is not suitable for those with certain types of aneurysms or other health conditions that might interfere with the study. As an unphased trial, it offers an opportunity to contribute to medical knowledge and potentially benefit from innovative treatment options.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, this may affect your eligibility.

What prior data suggests that these stent graft systems are safe for treating abdominal aortic aneurysms?

Research shows that both the Endurant Stent Graft System and the Gore Excluder Endoprosthesis are generally well-tolerated by patients. Studies on the Endurant Stent Graft System indicate it is durable and has low rates of aneurysm-related deaths, suggesting safety for people with abdominal aortic aneurysms.

Similarly, the Gore Excluder Endoprosthesis has been tested for up to five years and has consistently proven safe and effective. One study found that 98.5% of patients did not experience major issues one year after treatment. These findings suggest both treatments are safe and likely well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Endurant Stent Graft System and the Excluder Endoprothesis for treating abdominal aortic aneurysms because they offer innovative approaches to endovascular aneurysm repair (EVAR). Unlike traditional open surgery, which involves a large incision to repair the aneurysm, these systems are minimally invasive, which can lead to quicker recovery times and less post-operative discomfort. The Endurant Stent Graft System is known for its flexibility and ability to conform to various aortic anatomies, while the Excluder Endoprothesis provides a unique conformable design that can accommodate challenging aneurysm shapes. These advancements potentially increase the success rate of EVAR procedures and expand treatment options for patients who might not be candidates for conventional surgery.

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

Research has shown that the Endurant Stent Graft System, one of the treatments in this trial, effectively treats abdominal aortic aneurysms (AAA). A ten-year study demonstrated strong long-term results, including successful placement and a low rate of complications such as leaks in the treated area. The Gore Excluder Endoprosthesis, another treatment option in this trial, has also been confirmed as effective and safe. Five-year data indicate it performs well for patients with certain artery conditions, with excellent safety and effectiveness. Both treatments have strong evidence supporting their use for AAA, making them promising options for patients in this trial. ^{1 6 7 8 9}

Who Is on the Research Team?

Marc L Schermerhorn, MD

Principal Investigator

Beth Israel Deaconess Medical Center, United States

Hence Verhagen, MD

Principal Investigator

Erasmus University Medical Center, Netherlands

Are You a Good Fit for This Trial?

This trial is for adults with abdominal aortic aneurysms large enough to require intervention, who can commit to follow-up visits. They must be suitable for both Medtronic Endurant and Gore Excluder stent graft systems. Those with connective tissue diseases, life expectancy under 3 years, severe kidney issues, or certain psychiatric conditions cannot join.

Inclusion Criteria

Your aortic aneurysm (AAA) fits the requirements for both the Medtronic Endurant II/IIs Stent Graft System and the Gore Excluder/Excluder Conformable AAA Endoprosthesis, as determined by your doctor and a specialized lab.

My aneurysm is at least 5 cm wide if I am a woman, or 5.5 cm if I am a man.

Subject and the treating physician agree that the subject will return for all required follow-up visits

Exclusion Criteria

I need immediate treatment for a ruptured aneurysm.

My treatment includes covering the internal iliac artery.

You are not planning to have any additional devices inserted during the main procedure, such as staples, stents, or embolization devices.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an EVAR procedure with either a Medtronic Endurant II/IIs Stent Graft System or Gore Excluder/Excluder Conformable AAA Endoprosthesis

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for sac regression and other outcomes with imaging collected at discharge, 30 days, and annually until 5 years

5 years

Multiple visits (in-person) at discharge, 30 days, annually

What Are the Treatments Tested in This Trial?

Interventions

• Endurant Stent Graft System
• Excluder Endoprothesis

Trial Overview The ADVANCE Trial compares the performance of two stent graft systems—Medtronic Endurant and Gore Excluder—in treating abdominal aortic aneurysms. Participants are randomly assigned one of the treatments and monitored through imaging to assess outcomes.

How Is the Trial Designed?

Group I: Medtronic Endurant II/IIs Experimental Treatment 1 Intervention

Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.

Group II: Gore Excluder / Excluder Conformable Experimental Treatment 1 Intervention

Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.

Endurant Stent Graft System is already approved in European Union, United States for the following indications:

Approved in European Union as Endurant Stent Graft System for:

• Abdominal Aortic Aneurysms

Approved in United States as Endurant Stent Graft System for:

• Abdominal Aortic Aneurysms

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials

78

Recruited

37,300+

Geoff Martha

Medtronic Cardiovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kendra J. Grubb

Medtronic Cardiovascular

Chief Medical Officer

MD from Emory University

Published Research Related to This Trial

The Endurant stent graft demonstrated a high primary technical success rate of 98% in treating abdominal aortic aneurysms (AAAs) in a study of 100 patients, even with 19% of patients having anatomical characteristics outside the manufacturer's instructions for use.

At the 1-year follow-up, the Endurant stent graft showed significant reductions in AAA size and comparable rates of complications, such as endoleaks and reinterventions, to other stent grafts, indicating its effectiveness and durability in real-life practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year multicenter results of 100 abdominal aortic aneurysm patients treated with the Endurant stent graft. van Keulen, JW., de Vries, JP., Dekker, H., et al.[2022]

The Endurant stent graft demonstrated a high primary clinical success rate of 77% at 4 years for treating abdominal aortic aneurysms (AAAs) in a study of 100 patients, indicating its effectiveness over the long term.

The study reported low AAA-related mortality at 3% and effective prevention of aneurysm growth, even in patients treated outside the manufacturer's instructions for use (IFU), although some required additional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of endovascular repair of infrarenal aortic aneurysms using the Endurant stent graft. Zandvoort, HJ., Gonçalves, FB., Verhagen, HJ., et al.[2014]

In a study of 277 patients with a median follow-up of 5.8 years, both the Endurant and Excluder stent grafts showed similar long-term clinical success rates (54.7% for Endurant and 58.1% for Excluder) in treating abdominal aortic aneurysms, indicating that either device can be effective.

However, the Endurant graft was associated with a higher rate of neck dilatation and a greater decline in renal function, suggesting that while both devices are effective, careful consideration of patient anatomy and potential risks is crucial in device selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results after standard endovascular aneurysm repair with the Endurant and Excluder stent grafts. Oliveira-Pinto, J., Oliveira, NFG., Bastos-Gonçalves, FM., et al.[2020]

The repositionable GORE EXCLUDER endograft significantly reduced the risk of misdeployment or migration compared to the original GORE EXCLUDER, with rates of 3.6% versus 10.9%, indicating better safety in placement for patients with aortoiliac aneurysms.

Using the GORE Dryseal introducer sheath resulted in a much lower need for intraoperative blood transfusions (1.1% vs 18.9%), suggesting it enhances safety during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved effectiveness of the repositionable GORE EXCLUDER AAA endoprosthesis featuring the C3 delivery system compared with the original GORE EXCLUDER AAA endoprosthesis for within the instructions for use treatment of aortoiliac aneurysms. Tsolakis, IA., Kakkos, SK., Papageorgopoulou, CP., et al.[2019]

The Endurant Stent Graft System was successfully deployed in all 80 patients with abdominal aortic aneurysms, demonstrating effective performance even in those with challenging aortic neck anatomies.

The device showed a low all-cause mortality rate of 5% and no serious complications such as device migrations or ruptures, with significant reductions in aneurysm size observed in nearly 43% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Final results of the prospective European trial of the Endurant stent graft for endovascular abdominal aortic aneurysm repair. Rouwet, EV., Torsello, G., de Vries, JP., et al.[2011]

In a clinical trial involving 80 patients with abdominal aortic aneurysms, the GORE EXCLUDER Conformable AAA Endoprosthesis system demonstrated 100% technical success and 98.5% effectiveness in preventing aneurysm-related events after one year.

The device showed excellent safety, with no major adverse events reported within the first 30 days, including no deaths or serious complications, and 100% freedom from aneurysm-related mortality over the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial. Rhee, R., Oderich, G., Han, S., et al.[2022]

The Endurant stent-graft is designed to treat challenging abdominal aortic aneurysm cases, showing excellent short-term technical and clinical success in regulatory trials and registries involving various patient anatomies.

Results indicate that the stent-graft performs comparably in patients treated outside its official instructions, although there is a noted risk of perioperative proximal endoleak type I, and long-term outcomes are still not fully established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of Endurant stent-graft for abdominal aortic aneurysm: the story about extension of instruction for use with persistent good results of stent-graft latest generation. Rancic, Z., Pecoraro, F., Pfammatter, T., et al.[2016]

In a study of 50 patients who underwent EVAR with the Excluder endograft, significant initial reductions in abdominal aortic aneurysm (AAA) sac size were observed at 6 months, 1 year, and 2 years, but these benefits diminished by the 3-year mark due to delayed sac growth and re-expansion in some patients.

Despite the low incidence of serious complications such as graft migration or AAA rupture, late sac growth or re-expansion occurred in 43% of patients by 4 years, highlighting the need for careful risk-benefit analysis when considering the Excluder device for AAA repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late abdominal aortic aneurysm enlargement after endovascular repair with the Excluder device. Cho, JS., Dillavou, ED., Rhee, RY., et al.[2016]

The GORE EXCLUDER Conformable AAA Endoprosthesis has been successfully implanted in humans, addressing challenges in endovascular repair for abdominal aortic aneurysms, particularly in patients with short or highly angulated necks.

This innovative device offers features like repositionability and optional angulation control, which may enhance the accuracy of placement and improve long-term outcomes compared to previous generations of endografts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial human experience with the GORE EXCLUDER Conformable AAA Endoprosthesis. Rhee, R., Peterson, B., Moore, E., et al.[2020]

Citations

1. medtronic.com medtronic.com/en-us/healthcare-professionals/products/cardiovascular/aortic/aortic-stent-grafts/endurant-ii-stent-graft-system.html

Endurant™ II/IIs Stent Graft System Data current as of September 2023. Verhagen. The ENGAGE Registry: Ten-year outcomes with the Endurant stent graft for endovascular abdominal aortic aneurysm ...

2. medtronic.com medtronic.com/en-us/healthcare-professionals/products/cardiovascular/aortic/aortic-stent-grafts/endurant-ii-stent-graft-system/clinical-evidence.html

Clinical Evidence - Endurant™ II/IIs Stent Graft System Data current as of September 2023. Verhagen. The ENGAGE Registry: Ten-year outcomes with the Endurant stent graft for endovascular abdominal aortic aneurysm ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40588161/

The ENGAGE Registry Ten Year Outcomes with ... This is the first study to report long term outcomes in a real world, global cohort of patients with abdominal aortic aneurysm treated with ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/P100021S063B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Endurant II/IIs Stent Graft System is intended for the treatment of abdominal aortic aneurysms (AAA) using an endovascular approach. When ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0741521420312416

Endurant stent graft demonstrates promising outcomes in ... Our primary outcome measure was 12-month treatment success, defined as successful endograft delivery and deployment and the absence of type I or III endoleak, ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/P100021S063D.pdf

II Endurant EndoAnchor system has not been evaluated. • The safety and effectiveness of the Endurant II/IIs Stent Graft System has not been evaluated in patients who ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10868145/

Outcomes of Endurant II Stent Graft According to Anatomic ... This study's objective was to evaluate Endurant II (Medtronic Inc, Minneapolis, Minnesota) stent graft's early and midterm outcomes and compare the results

8. medtronic.com medtronic.com/me-en/healthcare-professionals/products/cardiovascular/aortic-stent-grafts/endurantii/clinical-outcomes.html

Clinical Outcomes - Endurant II Endurant systems continue to prove durability and strength in evidence with consistently high sac regression and low aneurysm-related mortality (ARM).

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf10/p100021b.pdf

Summary of Safety and Effectiveness Data - accessdata.fda.gov The Endurant Stent Graft System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in ...