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Stent-Graft

Stent-Graft for Abdominal Aortic Aneurysm

N/A
Waitlist Available
Led By Matthew Eagleton, MD
Research Sponsored by Bolton Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement
Subject must have an infrarenal AAA that is > 4.5 cm in diameter for males, or > 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new stent-graft for people with abdominal aortic aneurysms. They want to see if it's safe and effective.

Who is the study for?
This trial is for individuals with an infrarenal abdominal aortic aneurysm (AAA) that's over 4.5 cm in diameter for males, or over 4.0 cm for females, or has grown by at least half a centimeter in the past six months. It's not open to those who've had previous AAA repairs, are in other studies, have taken investigational drugs within 30 days or devices within a year, or have certain complications like dissection.Check my eligibility
What is being tested?
The study is testing the Treovance Stent-Graft with Navitel Delivery System on patients with Abdominal Aortic Aneurysms to see if it's safe and works well. The stent-graft is implanted into the affected area of the aorta to support it and prevent rupture.See study design
What are the potential side effects?
While specific side effects aren't listed here, common risks associated with stent-grafts include blood vessel damage during implantation, movement of the graft after placement, leakage around the graft site (endoleak), blockage or narrowing of arteries (occlusion), and infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with an abdominal aortic aneurysm below my kidneys.
Select...
I have an abdominal aortic aneurysm larger than 4.5 cm (if male) or 4.0 cm (if female), or it has grown by 0.5 cm recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy
Primary Safety
Secondary outcome measures
Secondary Efficacy Endpoint -- Device-Related Complications
Secondary Efficacy Endpoint-- Secondary interventions
Secondary Safety Endpoint

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreovanceExperimental Treatment1 Intervention
Subjects who receive the Treovance stent-graft

Find a Location

Who is running the clinical trial?

Bolton MedicalLead Sponsor
15 Previous Clinical Trials
2,466 Total Patients Enrolled
Matthew Eagleton, MDPrincipal InvestigatorCleveland Clinic Foundaton
1 Previous Clinical Trials
143 Total Patients Enrolled

Media Library

Treovance Stent-Graft (Stent-Graft) Clinical Trial Eligibility Overview. Trial Name: NCT02009644 — N/A
Abdominal Aortic Aneurysm Research Study Groups: Treovance
Abdominal Aortic Aneurysm Clinical Trial 2023: Treovance Stent-Graft Highlights & Side Effects. Trial Name: NCT02009644 — N/A
Treovance Stent-Graft (Stent-Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02009644 — N/A

Frequently Asked Questions

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

Will this research be conducted with elderly participants?

"Eligibility for this particular clinical trial is restricted to patients that are between 18 and 85 years old. In contrast, there are 8 trials that are only enrolling patients below the age of eighteen and 158 studies recruiting participants above 65."

Answered by AI

At how many locations is this research being conducted?

"The trial is based in University of Iowa Hospital and Clinic, situated in Iowa City, with other locations in University of Alabama-Birmingham, Birmingham, Arizona Heart Institute in Phoenix as well as 32 other sites."

Answered by AI

Are there any more spots left for people who want to participate in this research project?

"From the information on clinicaltrials.gov, it can be gathered that this trial is not presently looking for patients. This trial was initially posted on 11/23/2013 and was last updated on 6/25/2020; however, there are 160 other trials enrolling patients at this time."

Answered by AI

Could I qualify to be a subject in this clinical trial?

"Aneurysm patients who are between 18 and 85 years old may be eligible for this study. Up to 150 people can participate."

Answered by AI

Does the Treovance stent-graft have FDA approval for use in human subjects?

"This is a Phase 2 trial, which means that while there are safety data, there are no efficacy data. Therefore, the Power team gave it a rating of 2."

Answered by AI
~13 spots leftby Mar 2025