Stent Graft Systems for Abdominal Aortic Aneurysm

(JAGUAR Trial)

Recruiting at 28 trial locations

Overseen By Wei Zhou, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endologix

Disqualifiers: Connective tissue disorders, Active infection, others

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

Compensation: Varies

Number of Visits: 1

Duration: Procedure to discharge

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test and compare two stent graft systems for treating abdominal aortic aneurysms, a condition where a large blood vessel in the abdomen swells dangerously. Participants will receive either the Alto Abdominal Stent Graft System or another commonly used endovascular graft system, with their health outcomes tracked for up to five years. Individuals with an unruptured abdominal aortic aneurysm who qualify for endovascular repair (a minimally invasive surgery) might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future 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 team or your doctor.

What prior data suggests that these stent graft systems are safe for abdominal aortic aneurysm repair?

Research has shown that the Alto Abdominal Stent Graft System is generally safe for treating abdominal aortic aneurysms (AAA). One study found it successful 96.7% of the time after 12 months, maintaining effectiveness for five years without major issues. This indicates the device performed well and did not cause significant problems during that period. Another study confirmed that the system met safety standards after one year, showing it is well-tolerated by patients. The FDA has approved the Alto system, further supporting its safety for treating AAA. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Alto Abdominal Stent Graft System is unique because it offers a novel approach to repairing abdominal aortic aneurysms. Unlike traditional endovascular aneurysm repair (EVAR) systems, which often require precise anatomical conditions to fit properly, the Alto system features a more adaptable design that can accommodate a wider range of patient anatomies. This flexibility could potentially make it a more inclusive option for patients who were previously ineligible for standard EVAR procedures. Researchers are excited about the Alto system because it could expand the pool of patients who can benefit from minimally invasive aneurysm repair, reducing the need for open surgery and potentially improving patient outcomes.

What evidence suggests that these stent graft systems are effective for abdominal aortic aneurysm repair?

Research has shown that the Alto Abdominal Stent Graft System, one of the treatments in this trial, effectively treats abdominal aortic aneurysms (AAAs). One study found it was successful 96.7% of the time after 12 months, effectively sealing the aneurysm. Over four years, no deaths related to the aneurysm occurred, suggesting the stent graft is long-lasting and dependable. At one and six months, patients experienced 100% success, with no leaks or movement of the stent. Overall, the Alto Stent Graft System has demonstrated strong results in keeping AAAs stable and patients safe. Another arm of this trial will compare these results with those of FDA-approved EVAR AAA Graft Systems, which are also used for AAA repair. ^{1 2 3 6 7}

Who Is on the Research Team?

Sean Lyden, MD

Principal Investigator

The Cleveland Clinic

Christopher Kwolek, MD

Principal Investigator

Newton-Wellesley Hospital

Hence Verhagen, MD, PhD

Principal Investigator

Erasmus University Study Center

Are You a Good Fit for This Trial?

The JAGUAR Trial is for adults over 21 with an unruptured infrarenal abdominal aortic aneurysm (AAA) who are expected to live at least two more years. Participants must be able to follow the study's procedures and have signed consent forms. Those with allergies to device materials, pregnant women, or individuals currently in another trial cannot join.

Inclusion Criteria

Subjects with minimum of 2 year life expectancy

I am 21 years old or older.

Subjects have signed the informed consent document

Exclusion Criteria

Known allergy to any of the device components

Currently participating in another trial where the primary endpoint has not been reached yet

Pregnant (females of childbearing potential only)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the Endologix Alto Abdominal Stent Graft System or a comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm

Procedure to discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1, 6, 12 months and annually through to 5 years

5 years

Visits at 1, 6, 12 months and annually

What Are the Treatments Tested in This Trial?

Interventions

• Alto Abdominal Stent Graft System
• FDA Approved EVAR AAA Graft Systems

Trial Overview This study compares two treatments for AAA: the Alto Abdominal Stent Graft System versus FDA-approved EVAR graft systems. Patients will be randomly assigned to one of these options and monitored from procedure time up until five years post-treatment.

How Is the Trial Designed?

Group I: Alto Abdominal Stent Graft System Experimental Treatment 1 Intervention

Subjects randomized to receive the Endologix Alto Abdominal Stent Graft System for implantation to repair Abdominal Aortic Aneurysm.

Group II: Comparators Active Control 1 Intervention

Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm.

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

Approved in United States as Alto Abdominal Stent Graft System for:

• Abdominal aortic aneurysm repair

Approved in European Union as Alto Abdominal Stent Graft System for:

• Abdominal aortic aneurysm repair

Who Is Running the Clinical Trial?

Endologix

Lead Sponsor

Trials

23

Recruited

3,900+

Published Research Related to This Trial

The ALTO abdominal stent graft system was successfully used to treat six male patients with abdominal aortic aneurysms, including two with juxtarenal aneurysms, with all procedures being uneventful.

At one-month follow-up, imaging showed no complications such as endoleak or graft failure, indicating promising early outcomes for this new polymer-based device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular Juxtarenal Aortic Aneurysm Repair Using the ALTO Abdominal Stent Graft System: The First Case Series. Efthymiou, FO., Tsimpoukis, AL., Papatsirou, MA., et al.[2023]

The study proposes a new design for stent-grafts used in endovascular aortic aneurysm repair (EVAR) that features non-equal-strut stent hoops, which improves mechanical performance by balancing radial support force and longitudinal flexibility.

Numerical simulations and physical experiments demonstrate that this new design can help reduce complications like endoleak and stent-graft migration, enhancing the overall safety and efficacy of thoracic aortic aneurysm treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of non-equal-strut stent hoops for structural optimization of thoracic aortic stent-grafts. Yan, S., Song, C., Si, Y., et al.[2022]

The Alto Abdominal Stent Graft System demonstrated 100% procedural technical success in the first seven patients treated, indicating its effectiveness in endovascular aneurysm repair.

At the 12-month follow-up, there were no reported complications such as endoleaks, stent graft migration, or aneurysm-related mortality, suggesting a strong safety profile for this new device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with polymer endovascular aneurysm repair using the Alto stent graft. Holden, A., Lyden, S.[2020]

Stent grafting for abdominal aortic aneurysms (AAAs) has improved endovascular surgery, offering benefits like reduced operating time, less blood loss, and shorter hospital stays compared to traditional open surgery.

Despite its advantages, the use of endovascular grafts is recommended primarily for high-risk patients due to potential complications, and careful patient selection is crucial based on anatomy, device suitability, and the need for ongoing surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stent grafts for the treatment of abdominal aortic aneurysms. Diethrich, EB.[2019]

In a multicenter trial involving 75 patients, the Endologix Alto Stent Graft System demonstrated a high treatment success rate of 96.7% at one year for treating abdominal aortic aneurysms (AAAs), indicating its effectiveness in this patient population.

The safety profile was also favorable, with a low 30-day major adverse event rate of 5.3% and no AAA-related mortality reported, suggesting that the device is a safe option for patients with appropriate anatomical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial. Lyden, SP., Metzger, DC., Henao, S., et al.[2023]

In a study involving 7 male patients with an average age of 76.1 years, the Ovation Alto stent-graft demonstrated technical success in all cases for endovascular aneurysm repair (EVAR), allowing treatment in patients with challenging aortic neck anatomies.

No significant complications such as type IA/IB/III endoleaks or major stent-graft migrations were observed during follow-up, indicating promising early safety and efficacy of the Alto stent-graft in a wider range of aortic anatomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Experience with Ovation Alto Stent-Graft. Cuozzo, S., Martinelli, O., Brizzi, V., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36028158/

One-year safety and effectiveness of the Alto abdominal ... This prospective study demonstrates the Endologix Alto is safe and effective in treating AAAs with appropriate anatomy at 1 year. The safety endpoint is met ...

2. jvascsurg.org jvascsurg.org/article/S0741-5214(22)02205-4/fulltext

One-year safety and effectiveness of the Alto abdominal ... The combined Ovation 5-year outcomes were reported in the ENCORE trial and noted excellent durability with freedom from abdominal aortic ...

3. cureus.com cureus.com/articles/418086-four-year-experience-with-the-alto-stent-graft-in-abdominal-aortic-aneurysms-with-hostile-features

Four-Year Experience With the ALTO Stent Graft in ... We observed no aneurysm-related mortality. Conclusion: The ALTO stent-graft system demonstrates an effective and durable seal in abdominal ...

4. endologix.com endologix.com/news/elevate-ide-study-highlights-the-safety-and-effectiveness-of-the-alto-abdominal-stent-graft-system-in-one-year-results-data-to-be-presented-at-2022-veithsymposium/

ELEVATE IDE Study highlights the Safety and ... The Endologix ALTO Stent Graft System treats abdominal aortic aneurysms (AAA) with a success rate of 96.7% at 12 months as observed in ELEVATE IDE Study.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666688X21000630

Early Experience with the New Ovation Alto Stent Graft in ... At one and six month follow up, there was 100% clinical success (no type I/III endoleak, sac enlargement, stent graft migration, polymer leakage, abdominal ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/P120006S031B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Alto™ Abdominal Stent Graft System is an endovascular device delivered via a low- profile catheter to treat abdominal aortic aneurysms (AAAs) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9233984/

Endovascular Juxtarenal Aortic Aneurysm Repair Using ... Regarding its technical success, according to the FDA Summary of Safety and Effectiveness Data [5], 58 of 61 patients (95%) treated with the ALTO abdominal ...