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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

TREO PAS Trial Summary

This trial is testing a new device to treat abdominal aortic aneurysms or aorto-iliac aneurysms. The goal is to see how well it works in the long term.

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.Check my eligibility

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.See study design

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.

TREO PAS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

TREO PAS 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

Find a Location

Who is running the clinical trial?

Bolton MedicalLead Sponsor

15 Previous Clinical Trials

2,316 Total Patients Enrolled

Media Library

TREO Abdominal Stent-Graft System (Stent-Graft) Clinical Trial Eligibility Overview. Trial Name: NCT04697784 — N/A

Abdominal Aortic Aneurysm Research Study Groups: Subjects who receive the TREO Abdominal Stent-Graft System

Abdominal Aortic Aneurysm Clinical Trial 2023: TREO Abdominal Stent-Graft System Highlights & Side Effects. Trial Name: NCT04697784 — N/A

TREO Abdominal Stent-Graft System (Stent-Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04697784 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary goal of this experimental research?

"This trial, which will be tracked for up to 5 years post-procedure, aims to measure the incidence of stent-strut fracture or barb separation as documented by an imaging core laboratory. Secondary objectives include Major Adverse Events (e.g., myocardial infarction) and Incidence of conversion to open surgical AAA repair during the initial EVAR procedure as well as Incidence of stent-graft occlusion due to causes like twisting/kinking prosthesis, oversizing fabric pleating, implant failure to fully open etc."

Answered by AI

How many participants are currently affiliated with this research project?

"This clinical trial calls for 300 individuals who satisfy the prerequisites. Potential participants can find locations to join in La Jolla, California and Tucson, Arizona respectively at University of California San Diego and Pima Heart & Vascular."

Answered by AI

Is there room for participants to still join this experiment?

"Clinicaltrials.gov confirms that the study is currently enrolling participants, with an initial posting date of January 20th 2021 and a most recent update on May 13th 2022."

Answered by AI

How many venues are conducting this experiment?

"The research is conducted from the University of California, San Diego in La Jolla, Pima Heart and Vascular in Tucson, as well as Minneapolis Heart Institute / Abbott Northwestern Hospital. Additionally, there are 40 other locations participating in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Post-Approval Study of the TREO Abdominal Stent-Graft System

2021. "Post-Approval Study of the TREO Abdominal Stent-Graft System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04697784.

All > Abdominal Aortic Aneurysm