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Endovascular Device

Endografts for Aortic Aneurysm

N/A

Recruiting

Led By Sukgu M Han, MD, MS

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Symptomatic aneurysm without hemodynamic instability

Aneurysm with a history of growth ≥ 0.5cm per year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after the surgery

Awards & highlights

Study Summary

This trial is designed to assess the safety and effectiveness of physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects who are at high risk for open repairs.

Who is the study for?

This trial is for adults with specific types of aortic aneurysms that are at high risk for rupture or have shown significant growth. It's aimed at those who can't be treated with FDA-approved devices, aren't part of another similar clinical trial, and have a life expectancy over two years.Check my eligibility

What is being tested?

The study tests physician-modified fenestrated/branched endografts in repairing complex aortic aneurysms in high-risk patients. It aims to evaluate the safety and effectiveness immediately after surgery, then periodically up to five years.See study design

What are the potential side effects?

Potential side effects may include complications related to the implantation procedure such as bleeding, infection, blood vessel damage, graft movement or leakage around the graft (endoleak), and possibly worsened frailty.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have symptoms from an aneurysm but am not in shock.

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My aneurysm has grown at least 0.5cm in a year.

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My aneurysm is in the chest or abdomen area and is at least 5cm wide or twice the normal size.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-days, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30-days, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-days, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rate of Major Adverse Events

Secondary outcome measures

Rate of Technical Success

Rate of Treatment Success

Trial Design

1Treatment groups

Experimental Treatment

Group I: PMEG FEVARExperimental Treatment1 Intervention

The only arm of this study will be enrolled subjects who undergo physician modified endografting as a treatment of their thoracoabdominal aortic aneurysms or complex abdominal aortic aneurysms.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,596,188 Total Patients Enrolled

Sukgu M Han, MD, MSPrincipal InvestigatorUniversity of Southern California

Media Library

Physician Modified Endografts (Endovascular Device) Clinical Trial Eligibility Overview. Trial Name: NCT04524247 — N/A

Thoracoabdominal Aortic Aneurysms Research Study Groups: PMEG FEVAR

Thoracoabdominal Aortic Aneurysms Clinical Trial 2023: Physician Modified Endografts Highlights & Side Effects. Trial Name: NCT04524247 — N/A

Physician Modified Endografts (Endovascular Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04524247 — 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 total enrollment limit for this clinical trial?

"Affirmative, the available material on clinicaltrials.gov suggests that this research is currently recruiting participants. After being initially posted on February 23rd 2021, it was recently updated in May of 2022 and requires roughly 100 volunteers to participate at 1 location."

Answered by AI

Would it be possible to enroll in this research initiative at the present time?

"According to clinicaltrials.gov, this trial is currently open for enrollment; it was first posted on February 23rd 2021 and updated most recently on May 6th 2022."

Answered by AI

Recent research and studies

European Journal of Vascular and Endovascular SurgeryJournal

Editor's Choice – Ten-year Experience with Endovascular Repair of Thoracoabdominal Aortic Aneurysms: Results from 166 Consecutive Patients

Verhoeven, E.L.G., A. Katsargyris, F. Bekkema, K. Oikonomou, C.J.A.M. Zeebregts, W. Ritter, and I.F.J. Tielliu. 2015. “Editor's Choice – Ten-year Experience with Endovascular Repair of Thoracoabdominal Aortic Aneurysms: Results from 166 Consecutive Patients”. European Journal of Vascular and Endovascular Surgery. Elsevier BV. doi:10.1016/j.ejvs.2014.11.018.

Journal of Vascular SurgeryJournal

Efficacy and Durability of Endovascular Thoracoabdominal Aortic Aneurysm Repair Using the Caudally Directed Cuff Technique

Reilly, Linda M., Joseph H. Rapp, S. Marlene Grenon, Jade S. Hiramoto, Julia Sobel, and Timothy A.M. Chuter. 2012. “Efficacy and Durability of Endovascular Thoracoabdominal Aortic Aneurysm Repair Using the Caudally Directed Cuff Technique”. Journal of Vascular Surgery. Elsevier BV. doi:10.1016/j.jvs.2012.01.006.

Journal of Endovascular TherapyJournal

Systematic Review of Off-the-shelf or Physician-modified Fenestrated and Branched Endografts

Georgiadis, George S., Joost A. van Herwaarden, George A. Antoniou, Constantijn E. V. B. Hazenberg, Athanasios D. Giannoukas, Miltos K. Lazarides, and Frans L. Moll. 2015. “Systematic Review of Off-the-shelf or Physician-modified Fenestrated and Branched Endografts”. Journal of Endovascular Therapy. SAGE Publications. doi:10.1177/1526602815611887.

European Journal of Vascular and Endovascular SurgeryJournal