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Frailty and Physician Modified Endograft for Aortic Aneurysms

This study is looking at a new way to treat serious conditions like thoracoabdominal aortic aneurysms (a bulging in the body's main artery) and other complex aortic problems. It uses "Physician Modified Endografts" (special devices that are customized by doctors) to repair these aneurysms. The study wants to see how safe and effective these modified devices are, especially for patients who might be considered frail or at high risk for traditional open surgery. Researchers will be checking for any major problems right after surgery and for up to 5 years. The study aims to enroll 100 participants.

Study design
This is a single-arm study, meaning all participants will receive the same treatment. It plans to enroll 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for major adverse events immediately after surgery up to 30 days, and then at 3 months, 6 months, 12 months, and annually for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04524247

Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies

Recruiting
NAAges 18+InterventionalTreatment
University of Southern California
~100 participants
Updated 2024-07-01 on ClinicalTrials.gov
What's tested:Physician Modified Endografts

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Major Adverse Events
Measured over Immediately after the surgery up to 30 days. If the hospital stay exceeds 30 days, major adverse events that occur prior to discharge from hospital will be included.

Conditions

Thoracoabdominal Aortic Aneurysm
Thoracoabdominal; Aortic, Aneurysm, Dissecting
Pararenal Aneurysm
Frailty Syndrome

Explore related trials

Aortic AneurysmPararenal AneurysmThoracoabdominal aortic aneurysm

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Sukgu M Han, MD, MS · PRINCIPAL_INVESTIGATOR · University of Southern California

Who to contact

Katie O'Donnell, MPH
Kathleen.O'[email protected]
323-442-6835
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

Patients must be excluded from the study if any of the following conditions is true:

What this trial measures

  • Rate of Major Adverse EventsImmediately after the surgery up to 30 days. If the hospital stay exceeds 30 days, major adverse events that occur prior to discharge from hospital will be included.

    1. Aortic rupture within 30 days 2. Lesion-related mortality within 30 days 3. All-cause mortality within 30 days 4. Permanent paraplegia, defined by lack of resolution at 1 month follow-up 5. Permanent paraparesis, defined by lack of resolution at 1 month follow-up 6. Renal function decline resulting in \> 50% of estimated Glomerular Filtration Rate or New onset renal failure requiring dialysis, defined by ongoing dialysis at 1 month follow-up 7. Severe bowel ischemia, requiring laparotomy 8. Disabling stroke, reported within 30 days of the procedure, without resolution at 90 days post-procedure 9. Myocardial infarction 10. Respiratory failure requiring prolonged (\> 24 hours from anticipated) mechanical ventilation or reintubation