Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies

Launched by UNIVERSITY OF SOUTHERN CALIFORNIA · Aug 19, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a special type of medical device called a physician-modified fenestrated endograft, which is used to repair serious conditions affecting the thoracoabdominal aorta, such as aneurysms. An aneurysm is a bulge in the artery that can be dangerous if it grows too large or ruptures. The goal of this study is to see how safe and effective this device is for patients who are at high risk for traditional surgery due to their overall health, particularly focusing on those who may be considered frail. Researchers will monitor patients for 30 days after the procedure and then follow up at 3, 6, 12 months, and annually for five years to assess their outcomes.

To be eligible for this trial, patients need to be between 65 and 74 years old and have a specific type of aneurysm that meets certain size or growth rate criteria. It's important for participants to be willing to attend follow-up visits and to provide informed consent. Throughout the study, researchers will also evaluate how frail patients are before and after the procedure to better understand how frailty affects recovery and overall health. If you're considering participating, you'll be contributing to valuable research that may help improve treatment options for patients with similar conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated/branched stent grafts.
• • 1. Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter.
• • 2. Aneurysm with a history of growth ≥ 0.5cm per year.
• • 3. Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.
• • 4. Symptomatic aneurysm without hemodynamic instability
• • 5. Aneurysms meeting any of the above criteria 1\~4, above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.
• Exclusion Criteria:
• * Patients must be excluded from the study if any of the following conditions is true:
• • 1. Less than 18 years of age.
• • 2. Unwilling to comply with the follow-up schedule.
• • 3. Inability or refusal to give informed consent by the patient or a legally authorized representative.
• • 4. Pregnant or breastfeeding.
• • 5. Life-expectancy less than 2 years.
• • 6. Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol and performed remotely from the fenestrated procedure (\>30 days). Examples include remote (\>30days) participation in a thoracic, or abdominal branch device trial.
• • 7. Eligible for treatment with FDA-approved marketed device.
• • 8. Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.