Stent-Graft for Abdominal Aortic Aneurysm

Recruiting at 31 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bolton Medical

Disqualifiers: Aortic dissection, Ruptured aneurysm, Prior AAA repair, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: Procedure day

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to assess and evaluate the safety and efficacy of the Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic Aneurysms (AAA).

Research Team

Matthew Eagleton, MD

Principal Investigator

Cleveland Clinic Foundaton

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with an abdominal aortic aneurysm below my kidneys.

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

I have a serious issue with my abdominal aorta as diagnosed by my doctor.

Subject is participating in another research study, has received investigational study drug within 30 days of planned procedure, or has received an investigational device within one year of planned procedure

I have had surgery to repair an abdominal aortic aneurysm.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with the Treovance Stent-Graft with Navitel Delivery System

Procedure day

1 visit (in-person)

Post-procedure Assessment

Post-procedure assessments prior to hospital discharge and at 30 days, 6 months, and 12 months post-implantation

12 months

4 visits (in-person)

Follow-up

Annual follow-up visits to monitor safety and effectiveness out to 5 years

5 years

5 visits (in-person)

Treatment Details

Interventions

• Treovance Stent-Graft

Trial Overview 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.

Participant Groups

Group I: Treovance Experimental Treatment 1 Intervention

Subjects who receive the Treovance stent-graft

Who Is Running the Clinical Trial?

Bolton Medical

Lead Sponsor

Trials

17

Recruited

2,900+