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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
Must not have
Subject has a dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
Subject has had a prior AAA repair (endovascular or surgical)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious issue with my abdominal aorta as diagnosed by my doctor.
Select...
I have had surgery to repair an abdominal aortic aneurysm.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy
Primary Safety
Secondary study objectives
Secondary Efficacy Endpoint -- Device-Related Complications
Secondary Efficacy Endpoint-- Secondary interventions
Secondary Safety Endpoint

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: TreovanceExperimental Treatment1 Intervention
Subjects who receive the Treovance stent-graft

Find a Location

Who is running the clinical trial?

Bolton MedicalLead Sponsor
16 Previous Clinical Trials
2,701 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
~12 spots leftby Dec 2025
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