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

Trial Summary

What is the purpose of this trial?

Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population. Patients will be randomized into two device cohorts and compared across the primary endpoints. Patients will be followed procedurally to discharge, at 1, 6, 12 months and annually through to 5 years (total follow-up commitment).

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 data supports the effectiveness of the Alto Abdominal Stent Graft System treatment for abdominal aortic aneurysms?

The Alto Abdominal Stent Graft System has shown promising results in treating abdominal aortic aneurysms, with studies reporting no complications like endoleaks (leakage around the stent), device migration, or aneurysm-related deaths at follow-ups of up to 12 months. This suggests the treatment is effective and safe in the short term. ^{1 2 3 4 5}

Is the Alto Abdominal Stent Graft System safe for humans?

The Alto Abdominal Stent Graft System has shown promising safety outcomes in studies, with no major complications like device migration or aneurysm rupture reported at 1-year follow-up. However, lifelong monitoring is recommended to detect any late issues. ^{1 2 3 4 5}

What makes the Alto Abdominal Stent Graft System treatment unique for abdominal aortic aneurysms?

The Alto Abdominal Stent Graft System is unique because it features a polymer-based design with a sealing ring positioned closer to the top of the fabric, which helps improve the fit and seal in the aorta, reducing the risk of complications like endoleaks and device migration. ^{1 3 4 5 6}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Initial experience with polymer endovascular aneurysm repair using the Alto stent graft. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Early Experience with Ovation Alto Stent-Graft. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Endovascular Juxtarenal Aortic Aneurysm Repair Using the ALTO Abdominal Stent Graft System: The First Case Series. [2023]

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

One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Design of non-equal-strut stent hoops for structural optimization of thoracic aortic stent-grafts. [2022]