BridgeMD
New treatment option for Thoracoabdominal Aortic Aneurysm
Official title Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies
ClinicalTrials.gov ID: NCT04524247
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment...
- Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the...
- 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
You likely can't join if
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.