TREO Abdominal Stent-Graft System for Abdominal Aortic Aneurysm

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Iowa Hospital and Clinic, Iowa City, IAAbdominal Aortic AneurysmTREO Abdominal Stent-Graft System - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Abdominal Aortic Aneurysm

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Patients treated with the device

Study Objectives

2 Primary · 16 Secondary · Reporting Duration: Through 5 Years post-procedure

12 months post-implant
Incidence of successful aneurysm treatment
Through 5 Years post-procedure
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).
Incidence of aneurysm rupture
Incidence of aneurysm-related mortality
Incidence of conversion to open surgical repair.
Incidence of device stenosis or kink
Incidence of loss of device integrity
Incidence of procedure-related clinical utility measures
Incidence of procedure-related complications
Incidence of secondary intervention for adverse events related to or caused as a result of stent-strut fracture or barb separation.
Incidence of secondary interventions.
Incidence of stent-graft migration (>10mm as compared to 30-day imaging)
Incidence of stent-graft occlusion (i.e., loss of patency)
Incidence of stent-strut fracture or barb separation as confirmed by the Imaging Core Laboratory.
Major Adverse Events
Number of participants with technical success at the conclusion of the index procedure

Trial Safety

Safety Progress

1 of 3

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1
AAA Group (Aim 3A)
2
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1
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Trial Design

1 Treatment Group

Subjects who receive the TREO Abdominal Stent-Graft System
1 of 1

Experimental Treatment

300 Total Participants · 1 Treatment Group

Primary Treatment: TREO Abdominal Stent-Graft System · No Placebo Group · N/A

Subjects who receive the TREO Abdominal Stent-Graft System
Device
Experimental Group · 1 Intervention: TREO Abdominal Stent-Graft System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 5 years post-procedure

Who is running the clinical trial?

Bolton MedicalLead Sponsor
15 Previous Clinical Trials
2,326 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your aneurysm can be treated with the TREO Abdominal Stent-Graft System.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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