What side effects are associated with this type of intervention?

Endovascular stent-graft placement for treating Abdominal Aortic Aneurysm, such as the TREO Abdominal Stent-Graft, commonly presents side effects including endoleaks, stent-graft migration, infection, thrombosis, and access site complications like bleeding or hematoma. Other potential risks include renal impairment from contrast use and, rarely, spinal cord ischemia.

What prior FDA approvals exist?

The FDA has approved several endovascular stent-graft systems for the treatment of Abdominal Aortic Aneurysms (AAA). These devices, similar to the TREO Abdominal Stent-Graft, are designed to create a new pathway for blood flow, thereby reducing pressure on the aneurysm and preventing rupture. Notable examples include the Gore Excluder AAA Endoprosthesis, the Medtronic Endurant II Stent Graft System, and the Cook Zenith Flex AAA Endovascular Graft. These devices have been shown to be effective in minimally invasive repair of AAAs, offering an alternative to open surgical repair.

What other types of research exist?

Promising novel alternatives to the TREO Abdominal Stent-Graft for AAA treatment in 2024 include: 1) Multibranched endovascular repair techniques, which offer enhanced anatomical applicability and customization for complex aneurysms. 2) Newer generation stent-grafts with improved flexibility and conformability, reducing the risk of endoleaks and graft migration. 3) Drug-eluting stent-grafts that release medication to prevent restenosis and promote better healing. 4) Advanced imaging and navigation technologies, such as 3D printing and augmented reality, to improve precision in stent-graft placement.

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Stent-Graft

TREO Stent-Graft for Aneurysm (TREO PAS Trial)

N/A

Recruiting

Research Sponsored by Bolton Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 5 years post-procedure

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include complications related to implanting a stent-graft such as infection, bleeding, blood vessel damage or blockage, and issues related to device performance like migration or leakage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 5 years post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 5 years post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 years post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of secondary intervention for adverse events related to or caused as a result of stent-strut fracture or barb separation.

Incidence of stent-strut fracture or barb separation as confirmed by the Imaging Core Laboratory.

Secondary study objectives

Incidence of Type I, II, III, IV or V Endoleaks

Incidence of all-cause mortality

Incidence of aneurysm enlargement (>5mm as compared to 30-day imaging).

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects who receive the TREO Abdominal Stent-Graft SystemExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Endovascular stent-graft placement, a common treatment for Abdominal Aortic Aneurysm (AAA), involves inserting a stent-graft through the blood vessels to the aneurysm site. The stent-graft is expanded to create a new pathway for blood flow, bypassing the aneurysm and reducing pressure on its wall. This mechanism is vital for AAA patients as it prevents the aneurysm from expanding or rupturing, thereby reducing the risk of life-threatening complications.