Fenestrated TREO Stent-Graft for AAA

Recruiting at 4 trial locations

Overseen By Valerie Merkle

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bolton Medical

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Pregnancy, Severe CAD, Recent stroke, others

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

Compensation: Varies

Number of Visits: 31

Duration: Perioperative

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a stent-graft system designed to treat abdominal aneurysms, dangerous bulges in the aorta, the body's main blood vessel. The researchers aim to determine if the Fenestrated TREO Stent-Graft System can safely assist people with a specific aneurysm type near the kidneys. Participants will receive the stent-graft through a less invasive procedure and must visit the hospital for regular follow-ups over five years. This trial may suit individuals diagnosed with a juxtarenal abdominal aneurysm that affects their daily life. As an unphased trial, this study offers the opportunity to contribute to medical advancements and potentially improve participants' quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have a blood coagulation disorder that cannot be managed before and after the procedure, or if you cannot receive certain blood-thinning treatments during and after the procedure.

What prior data suggests that the Fenestrated TREO Stent-Graft System is safe for treating abdominal aneurysms?

Research has shown that the Fenestrated TREO Stent-Graft System is generally safe for treating abdominal aneurysms. One study successfully treated aneurysms in 93.1% of patients after one year, with most experiencing no serious complications. Long-term results indicated that the system remained effective over time, with few long-term health issues reported. These findings suggest that patients tolerate the treatment well, making it a promising option for those with this condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Fenestrated TREO Stent-Graft System is unique because it is specifically designed to treat juxtarenal Abdominal Aortic Aneurysms (AAA) with precision. Unlike traditional stent-grafts, this system features fenestrations—small openings that allow for better customization to fit the patient’s unique vascular anatomy. This tailored approach helps ensure that blood flow to critical arteries is maintained, reducing the risk of complications. Researchers are excited because this innovation could lead to safer and more effective outcomes for patients with complex AAAs compared to standard options.

What evidence suggests that the Fenestrated TREO Stent-Graft System is effective for treating abdominal aneurysms?

Research has shown that the Fenestrated TREO Stent-Graft System, which trial participants will receive, effectively treats abdominal aortic aneurysms (AAAs). Long-term studies have found that this stent-graft performs reliably with few complications over time. Designed for endovascular repair, the system can be placed inside the blood vessel with less invasive surgery. This approach is particularly beneficial for treating juxtarenal AAAs, where the aneurysm is near the kidneys. Overall, evidence supports the system’s effectiveness in safely managing these types of aneurysms. ^{1 2 5 6 7}

Who Is on the Research Team?

Benjamin W Starnes, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

Adults with a specific type of abdominal aneurysm called juxtarenal abdominal aortic aneurysm can join this trial. They must have at least one renal artery involved, meet certain size criteria for the aneurysm, and have a life expectancy greater than 2 years. People are excluded if their condition doesn't match these precise measurements or angles required by the study.

Inclusion Criteria

I am 18 years old or older.

1. Maximum aneurysm diameter of ≥5.5 cm for male ( ≥5.0 cm for female) or 2. Maximum AAA diameter exceeding two times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements (or saccular aneurysm that warrants treatment in the opinion of the investigator) or 3. Aneurysm with a history of growth \> 0.5 cm in 6 months

I have an aneurysm affecting a kidney artery, located at least 2mm below the celiac artery, and my aorta is healthy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants have the Fenestrated TREO Stent-Graft System implanted via an endovascular surgical procedure

Perioperative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with checkups, tests, and imaging scans

5 years

Visits at discharge, 30 days post-procedure, 6 months post-procedure, 12 months post-procedure, and annually thereafter

What Are the Treatments Tested in This Trial?

Interventions

• Fenestrated TREO Stent-Graft System

Trial Overview

The Fenestrated TREO Stent-Graft System is being tested to see if it's effective in treating abdominal aortic aneurysms. Participants will undergo surgery to implant this system and then be followed up with checkups and scans over five years.

How Is the Trial Designed?

Group I: Stage 1 - Roll-in Arm Experimental Treatment 1 Intervention

Minimum of 20 subjects (up to 30) with juxtarenal Abdominal Aortic Aneurysm (AAA), being treated with the Fenestrated TREO Stent-Graft System

Who Is Running the Clinical Trial?

Bolton Medical

Lead Sponsor

Trials

17

Recruited

2,900+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07026877

Endovascular Repair With Fenestrated TREO Stent-Graft ...

The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm ...

2.

trialx.com

trialx.com/clinical-trials/listings/326999/endovascular-repair-with-fenestrated/?&geo_lat=47.76095&geo_lng=-122.2055884&radius=10&place=Bothell&user_country=United%20States

Endovascular Repair With Fenestrated TREO Stent-Graft ...

The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40886742/

Long term safety and effectiveness of the TREO stent graft ...

Conclusions: Long-term follow-up for the TREO Stent-Graft System demonstrated durable performance, with low rates of long-term morbidity and ...

4.

terumoaortic.com

terumoaortic.com/wp-content/uploads/2023/06/Fenestrated-TREO-Product-Brochure-A4-PM-08431-ROW.pdf

Fenestrated TREO®

(2020) Safety and effectiveness of the TREO stent graft for the endovascular treatment of abdominal aortic aneurysms. Journal of Vascular Surgery. Advanced ...

5.

annalsofvascularsurgery.com

annalsofvascularsurgery.com/article/S0890-5096(24)00259-0/fulltext

One-hundred Consecutive Physician-Modified Fenestrated ...

Fenestrated endovascular aortic aneurysm repair (FEVAR) has been widely applied for the treatment of pararenal (PAA) and thoracoabdominal ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0741521420324915

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 at 1 year.

7.

terumoaortic.com

terumoaortic.com/terumo-aortic-announces-publication-of-the-primary-endpoint-results-from-the-treo-pivotal-study/

Terumo Aortic announces publication of the primary ...

A total of 150 patients with infrarenal abdominal aortic or aorto-iliac aneurysms were treated in 29 centres across the United States. Follow-up ...