Stent-Graft for Abdominal Aortic Aneurysm

Not currently recruiting at 31 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bolton Medical

Disqualifiers: Aortic dissection, Ruptured aneurysm, Prior AAA repair, others

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

Compensation: Varies

Number of Visits: 10

Duration: Procedure day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Treovance Stent-Graft, to determine its effectiveness and safety for individuals with abdominal aortic aneurysms (AAA). An AAA occurs when the aorta, a large blood vessel in the abdomen, balloons and risks bursting if untreated. The trial seeks participants with an AAA that is unusually large or has rapidly expanded in the past six months. Individuals cannot participate if they have already undergone AAA repair or are involved in another research study. As an unphased trial, this study provides a unique opportunity to contribute to medical advancements and potentially benefit from a new treatment option.

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

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 the Treovance Stent-Graft is safe for treating Abdominal Aortic Aneurysms?

Research has shown that the Treovance Stent-Graft is generally safe for patients with abdominal aortic aneurysms (AAA). In one study, only 0.7% of patients experienced major issues within the first 30 days. After a year, this increased to 5.4%, and by four years, it was 19.3%. These findings suggest that serious problems are rare, especially in the short term.

Another study found that the Treovance Stent-Graft successfully treated aneurysms in 93.1% of cases, indicating its effectiveness and minimal risk of serious side effects. Overall, the evidence suggests that the Treovance Stent-Graft is safe, with most complications occurring long after the initial treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Treovance Stent-Graft is unique because it is designed specifically for the minimally invasive repair of abdominal aortic aneurysms (AAA). Unlike traditional open surgery, which involves a large incision and longer recovery time, the Treovance Stent-Graft can be delivered through a catheter, significantly reducing recovery time and minimizing surgical risks. Researchers are excited about this treatment because it offers a potentially safer and less invasive alternative to current standard options like open surgical repair or other endovascular stent-grafts, while still effectively reinforcing the weakened section of the aorta to prevent rupture.

What evidence suggests that the Treovance Stent-Graft is effective for Abdominal Aortic Aneurysms?

Research shows that the Treovance Stent-Graft, which participants in this trial will receive, holds promise for treating abdominal aortic aneurysms (AAA). Studies have found it effective and safe, with the RATIONALE registry reporting good results in real-world use. In a study of 150 patients, no deaths, ruptures, or need for open surgery related to the aneurysm occurred even after five years. It also performs well for patients with challenging AAA anatomy. This evidence supports its potential effectiveness in managing AAA. ^{1 2 4 6 7}

Who Is on the Research Team?

Matthew Eagleton, MD

Principal Investigator

Cleveland Clinic Foundaton

Are You a Good Fit for This Trial?

This trial is for individuals with an infrarenal abdominal aortic aneurysm (AAA) that's over 4.5 cm in diameter for males, or over 4.0 cm for females, or has grown by at least half a centimeter in the past six months. It's not open to those who've had previous AAA repairs, are in other studies, have taken investigational drugs within 30 days or devices within a year, or have certain complications like dissection.

Inclusion Criteria

I have been diagnosed with an abdominal aortic aneurysm below my kidneys.

I have an abdominal aortic aneurysm larger than 4.5 cm (if male) or 4.0 cm (if female), or it has grown by 0.5 cm recently.

Exclusion Criteria

I have a serious issue with my abdominal aorta as diagnosed by my doctor.

Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure

I have had surgery to repair an abdominal aortic aneurysm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with the Treovance Stent-Graft with Navitel Delivery System

Procedure day

1 visit (in-person)

Post-procedure Assessment

Post-procedure assessments prior to hospital discharge and at 30 days, 6 months, and 12 months post-implantation

12 months

4 visits (in-person)

Follow-up

Annual follow-up visits to monitor safety and effectiveness out to 5 years

5 years

5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Treovance Stent-Graft

Trial Overview The study is testing the Treovance Stent-Graft with Navitel Delivery System on patients with Abdominal Aortic Aneurysms to see if it's safe and works well. The stent-graft is implanted into the affected area of the aorta to support it and prevent rupture.

How Is the Trial Designed?

Group I: Treovance Experimental Treatment 1 Intervention

Subjects who receive the Treovance stent-graft

Who Is Running the Clinical Trial?

Bolton Medical

Lead Sponsor

Trials

17

Recruited

2,900+

Citations

1. terumoaortic.com terumoaortic.com/wp-content/uploads/2025/06/TREO-4-year-Annual-Report.pdf

TREO Abdominal Stent-Graft System (P190015) 4-year ... This annual clinical update provides a review of the ongoing experience with the TREO Abdominal. Stent-Graft System used in the treatment of abdominal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6238168/

Global Post-Market Clinical Follow-up of the Treovance Stent ... The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0741521425016647

Long term safety and effectiveness of the TREO stent graft ... Key Findings: In 150 patients treated with EVAR using TREO, 5-year follow-up showed no aneurysm-related mortality, ruptures, or open conversions ...

4. clinicaltrial.be clinicaltrial.be/en/details/12103?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Clinical Study of the Treovance Stent-Graft for Patients... This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the Treovance Stent-Graft in subjects with abdominal aortic aneurysms.

5. jvascsurg.org jvascsurg.org/article/S0741-5214(20)31356-2/fulltext

The Treovance aortic stent graft can confer advantage in ... The Treovance aortic stent graft can confer advantage in dealing with the patient origin-related unfavorable abdominal aortic aneurysm anatomy.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02009644

NCT02009644 | Clinical Study of the Treovance Stent-Graft ... The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with ...

7. jvascsurg.org jvascsurg.org/article/S0741-5214(20)32491-5/fulltext

Safety and effectiveness of the TREO stent graft for ... The safety and effectiveness of endovascular repair of abdominal aneurysms with TREO were demonstrated, with 93.1% successful aneurysm treatment ...