TREO Stent-Graft for Aneurysm

(TREO PAS Trial)

Recruiting at 39 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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the TREO Abdominal Stent-Graft, a device used to treat abdominal aneurysms by reinforcing blood vessel walls. It targets patients with specific types of aneurysms at risk of bursting. The device works by acting like a scaffold inside the blood vessel, preventing rupture. The TREO stent graft is a latest generation device.

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 TREO Abdominal Stent-Graft System treatment?

The TREO stent-graft system is designed for repairing abdominal aortic aneurysms (bulging in the main blood vessel that supplies blood to the abdomen, pelvis, and legs) and has shown promising early results in single-center studies, with good technical and clinical success. It offers accurate placement and secure sealing, which are important for effective treatment. ^{1 2 3 4 5}

Is the TREO Stent-Graft safe for use in humans?

The TREO Stent-Graft has shown promising early results with acceptable technical and clinical success in treating abdominal aortic aneurysms, and it is considered a latest generation device. However, long-term safety data is still being evaluated, and early issues with similar devices included complications like device rupture and stent fracture. ^{1 2 3 4 6}

How is the TREO stent-graft treatment different from other treatments for abdominal aortic aneurysms?

The TREO stent-graft is unique because it combines suprarenal and infrarenal fixation, has a lock-stent mechanism for stability, and offers a custom-made solution, making it adaptable to different patient anatomies and potentially improving outcomes in complex cases. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The Bolton Treo endograft for treatment of abdominal aortic aneurysms: just another trimodular platform? [2018]

2. Netherlands 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. [2017]

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

Update on the TREO endograft device: overview of its safety and efficacy. [2022]

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

Safety and effectiveness of the TREO stent graft for the endovascular treatment of abdominal aortic aneurysms. [2021]

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

Early Results of the Bolton Treovance Endograft in the Treatment of Abdominal Aortic Aneurysms. [2019]

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

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