TREO Stent-Graft for Aneurysm

(TREO PAS Trial)

Not currently recruiting at 57 trial locations

Overseen By Gretchen Wild

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bolton Medical

Disqualifiers: Medical, social, psychological problems, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the long-term effectiveness of the TREO Abdominal Stent-Graft for individuals with specific types of aneurysms, such as infrarenal abdominal aortic aneurysms or aorto-iliac aneurysms. Participants will receive the TREO Abdominal Stent-Graft to determine its effectiveness in treating their condition. Ideal candidates have these aneurysm types and can adhere to study procedures and visits. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from innovative treatment.

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 the TREO Abdominal Stent-Graft System is safe for treating aneurysms?

Research has shown that the TREO Abdominal Stent-Graft is generally safe for patients. One study reported that about 93.1% of patients experienced successful treatment of their aneurysms after one year. Another study found very few complications in patients over the long term. Serious problems occurred in only 0.7% of patients within the first 30 days, with this rate increasing slowly to 19.3% over four years. Additionally, after four years, experts found no evidence of leaks, blockages, or movement of the stent-graft in some patients. Overall, these studies suggest that the TREO Stent-Graft is well-tolerated for treating abdominal aneurysms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TREO Abdominal Stent-Graft System is unique because it offers a new approach to treating abdominal aortic aneurysms. Unlike traditional open surgical repair, which involves a major operation, the TREO system is designed for minimally invasive placement, potentially reducing recovery time and complications. Researchers are excited about this treatment as it could provide a safer, less invasive alternative with the same effectiveness as existing endovascular aneurysm repair (EVAR) options. The system's innovative design aims to enhance durability and adaptability to various patient anatomies, making it a promising option for a broader range of patients.

What evidence suggests that the TREO Abdominal Stent-Graft System is effective for treating Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms?

Research has shown that the TREO Abdominal Stent-Graft System effectively treats abdominal aortic aneurysms. One study found that 93.1% of patients experienced successful treatment after one year. Over five years, none of the patients died or had ruptures related to the aneurysm. The rate of major side effects remained low, with 0.7% of patients experiencing them at 30 days and 19.3% at four years. These findings indicate that the TREO system is both safe and effective for long-term use. ^{1 2 3 6 7}

Who Is on the Research Team?

Gretchen Wild

Principal Investigator

Terumo Aortic

Are You a Good Fit for This Trial?

This trial is for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms who can follow the study's procedures and visits, have given written consent, have adequate medical records for analysis, and whose aneurysm can be treated with the TREO System. Those with conditions that make them unsuitable for this treatment are excluded.

Inclusion Criteria

Willing and able to comply with all study procedures and visits.

Adequate data (medical records/imaging studies) available to analyze the primary endpoints for patients enrolled retrospectively.

Written informed consent to participate in the study.

Exclusion Criteria

Medical, social or psychological problems that, in the opinion of the investigator, preclude patient from receiving treatment with the TREO Abdominal Stent-Graft System.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Eligible subjects will be implanted with the TREO Abdominal Stent-Graft System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Regular follow-up visits as per study protocol

Long-term monitoring

Collection of real-world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System

5 years

What Are the Treatments Tested in This Trial?

Interventions

• TREO Abdominal Stent-Graft System

Trial Overview The study aims to evaluate the long-term effectiveness of the TREO Abdominal Stent-Graft System in treating abdominal aortic aneurysms. It involves monitoring patients who receive this specific stent-graft to see how well it works over time.

How Is the Trial Designed?

Group I: Subjects who receive the TREO Abdominal Stent-Graft System Experimental Treatment 1 Intervention

Eligible subjects will be implanted with the TREO Abdominal Stent-Graft System.

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

Approved in European Union as TREO for:

• Infrarenal Abdominal Aortic Aneurysms
• Aorto-iliac Aneurysms

Approved in United States as TREO for:

• Infrarenal Abdominal Aortic Aneurysms
• Aorto-iliac Aneurysms

Approved in Japan as TREO for:

• Abdominal Aortic Aneurysms

Who Is Running the Clinical Trial?

Bolton Medical

Lead Sponsor

Trials

17

Recruited

2,900+

Published Research Related to This Trial

The TREO abdominal aortic stent graft system has shown high technical success (96%) and clinical success (92.2%) in a multicenter study involving 202 patients, indicating its efficacy for endovascular repair of abdominal aortic aneurysms (AAA).

The device is particularly effective in challenging anatomical situations, such as hostile neck anatomies, achieving comparable technical success rates (95.2%) in these cases, suggesting its safety and versatility in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on the TREO endograft device: overview of its safety and efficacy. Georgakarakos, E., Karaolanis, GI., Argyriou, C., et al.[2022]

A custom-made conical TREO® stent graft was successfully used to treat a 5.2 cm saccular abdominal aortic aneurysm (AAA) in a 65-year-old female patient, who had a tight and calcified distal neck that made traditional bifurcated endografts unsafe.

After 6 months, the treatment resulted in complete sealing of the AAA and a reduction in the sac size to 45 mm, demonstrating the efficacy of this tailored approach in complex AAA cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom-Made Conical Endograft in the Treatment of Saccular Abdominal Aortic Aneurysms with Tight and Calcified Distal Neck: Thinking Out of the Box. Georgakarakos, E., Argyriou, C., Schoretsanitis, N., et al.[2017]

The Treo abdominal aortic stent graft system offers unique features like suprarenal and infrarenal fixation, which enhance its stability and deployment accuracy for repairing abdominal aortic aneurysms (AAA).

Early results from single-center studies indicate that the Treo system has acceptable technical and clinical success, suggesting it could be a valuable addition to the tools available for endovascular specialists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Bolton Treo endograft for treatment of abdominal aortic aneurysms: just another trimodular platform? Georgakarakos, E., Kratimenos, T., Koutsoumpelis, A., et al.[2018]

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 TREO stent graft demonstrated a high success rate of 93.1% in treating abdominal aortic aneurysms at 1 year, indicating its effectiveness as a treatment option.

The procedure showed excellent safety with a major adverse event (MAE) incidence of only 0.7% at 30 days, and over half of the patients (54.3%) experienced significant aneurysm sac shrinkage (>5 mm) by 3 years, suggesting promising long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of the TREO stent graft for the endovascular treatment of abdominal aortic aneurysms. Eagleton, MJ., Stoner, M., Henretta, J., et al.[2021]

The Treovance aortic stent-graft demonstrated a high primary technical success rate of 94% in treating abdominal aortic aneurysms (AAAs) among 35 patients, with no serious adverse events or AAA ruptures reported during a mean follow-up of 12 months.

Clinical success was achieved in 97% of patients, indicating that Treovance is effective even in challenging anatomical conditions, such as angulated and tortuous iliac vessels, with a low reintervention rate of 3%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Results of the Bolton Treovance Endograft in the Treatment of Abdominal Aortic Aneurysms. Georgakarakos, E., Pitoulias, G., Schoretsanitis, N., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33253871/

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.

2. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?t_id=668342&c_id=6086

Post-Approval Studies (PAS) Database - accessdata.fda.gov The objective of the study is to collect real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population ...

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

TREO Abdominal Stent-Graft System (P190015) 4-year ... A multi-center, non-randomized, single arm clinical study was initiated to collect real world safety and effectiveness outcomes of the TREO Abdominal Stent- ...

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

Long-term safety and effectiveness of the TREO stent graft ... Kaplan-Meier estimates of the major adverse event rates were 0.7% at 30 days, 5.4% at 12 months, 11.0% at 2 years, 16.2% at 3 years, 19.3% at 4 ...

5. jvascsurg.org jvascsurg.org/article/S0741-5214(25)01664-7/abstract

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, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04697784

Post-Approval Study of the TREO Abdominal Stent-Graft ... The primary objective is the collection of real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population ...

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

Long term safety and effectiveness of the TREO stent graft ... Kaplan-Meier estimates of the major adverse event rates were 0.7% at 30 days, 5.4% at 12 months, 11.0% at 2 years, 16.2% at 3 years, 19.3% at 4 ...