Stent Graft Systems for Abdominal Aortic Aneurysm

(ADVANCE Trial)

Recruiting at 62 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

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.

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

Research shows that the Endurant and Excluder stent grafts are effective for treating abdominal aortic aneurysms, with studies reporting positive long-term outcomes and improvements in device performance, especially in challenging anatomical situations. ^{1 2 3 4 5}

Is the Endurant Stent Graft System safe for treating abdominal aortic aneurysms?

The Endurant Stent Graft System has been shown to be safe for treating abdominal aortic aneurysms, with studies reporting good short-term and mid-term results. However, long-term safety data is still limited. ^{1 2 6 7 8}

How does the Endurant and Excluder stent graft treatment for abdominal aortic aneurysm differ from other treatments?

The Endurant and Excluder stent grafts are designed to treat abdominal aortic aneurysms, especially in patients with challenging anatomies, by offering features like active fixation and improved flexibility. These stent grafts allow for a broader range of anatomical eligibility and have shown good short-term and mid-term results, although long-term data is still limited. ^{1 2 6 8 9}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Final results of the prospective European trial of the Endurant stent graft for endovascular abdominal aortic aneurysm repair. [2011]

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

Long-term results after standard endovascular aneurysm repair with the Endurant and Excluder stent grafts. [2020]

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

One-year results of the GORE EXCLUDER Conformable AAA Endoprosthesis system in the United States regulatory trial. [2022]

4. United States 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. [2019]

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

Initial human experience with the GORE EXCLUDER Conformable AAA Endoprosthesis. [2020]

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

One-year multicenter results of 100 abdominal aortic aneurysm patients treated with the Endurant stent graft. [2022]

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

Results of endovascular repair of infrarenal aortic aneurysms using the Endurant stent graft. [2014]

8. Italy 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. [2016]

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

Late abdominal aortic aneurysm enlargement after endovascular repair with the Excluder device. [2016]