Using modified stent grafts to treat complex aortic aneurysms in frail patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of physician-modified fenestrated and branched stent grafts for repairing thoracoabdominal and complex aortic aneurysms in patients who are at high risk for open surgery. It is a single-arm, prospective feasibility study that will assess clinical outcomes, including treatment success and major adverse events, over a period of up to five years. Additionally, the study will analyze the impact of patient frailty on these outcomes, measuring frailty levels before and after the procedure. The modifications to the stent grafts will be tailored based on 3-D imaging of the patient's anatomy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Keck Hospital of University of Southern California
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Sukgu M Han, MD, MS — University of Southern California
• Study coordinator: Katie O'Donnell, MPH
• Email: Kathleen.O'Donnell@med.usc.edu
• Phone: 323-442-6835

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Outcomes after physician-modified fenestrated and branched stent grafts for complex aortic aneurysms

  This study will test whether physician-modified fenestrated and branched stent grafts are safe and effective for people with juxtarenal, pararenal, or thoracoabdominal aortic aneurysms who are high risk for open surgery.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT06526676

• Endovascular treatment for thoracoabdominal aortic dissecting aneurysm

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• Urinary incontinence in older adults: how leakage and bladder residuals relate to frailty

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• Combined inspiratory muscle training with blood flow restriction for frail older adults

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  Recruiting Taipei Medical University · Taipei · NCT07573995

• Femorofemoral versus left‑heart bypass for open thoracoabdominal aortic aneurysm repair

  This will test whether femorofemoral bypass or left‑heart bypass works better for adults having open repair of a thoracoabdominal aortic aneurysm.

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• Multimodal prehabilitation before elective hip or knee replacement for frail older adults

  This program will test whether a tailored multimodal prehabilitation package can help frail adults aged 70 and older who are waiting at least two months for elective hip or knee replacement do better around the time of surgery.

  Recruiting University of Iceland · Reykjavik · NCT07465159

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.