Using modified stent grafts to treat complex aortic aneurysms in frail patients
Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts
This study is testing if specially designed stent grafts can safely help frail patients with complex aortic aneurysms instead of traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04524247 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with thoracoabdominal aortic aneurysms who are anatomically suitable for fenestrated/branched stent grafts and are at high risk for traditional surgical repair.
Not a fit: Patients under 18 years of age or those unwilling to comply with follow-up schedules may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for frail patients with complex aortic aneurysms.
How similar studies have performed: Other studies have shown promise with similar approaches using modified stent grafts, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.