NCT04524247 · University of Southern California
Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies
What this study is about
The primary objective of this single treatment group$1, forward-looking feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major side effects (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success). Additionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.
View original scientific description
The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success). Additionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.
Interventions
DEVICE
Physician Modified Endografts
Modification procedure Description of modified device is detailed in Section 3.5 of IDE. In summary, the steps involved in modification of the Zenith Alpha thoracic stent grafts are; 1. Unsheathing of the stent graft 2. Retrieval of a trigger wire from the inner cannula of the delivery system 3. Rerouting of the trigger wire along the stent graft 4. Removal of proximal barbs. 5. Creation of fenestrations and/or branch cuffs 6. Placement of radiopaque markers around the fenestrations/ branch cuffs 7. Placement of temporary and/or permanent diameter constraining ties 8. (Optional) Placement of preloaded wires through the fenestrations/branch cuffs
Primary outcome measures
Rate of Major Adverse Events
Time frame: 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.
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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.
- Aneurysm with a history of growth ≥ 0.5cm per year.
- Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.
- Symptomatic aneurysm without hemodynamic instability
- 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:
- Less than 18 years of age.
- Unwilling to comply with the follow-up schedule.
- Inability or refusal to give informed consent by the patient or a legally authorized representative.
- Pregnant or breastfeeding.
- Life-expectancy less than 2 years.
- 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.
- Eligible for treatment with FDA-approved marketed device.
- Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.
Where
- Los Angeles, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2024 · Source of record for eligibility and locations