Your session is about to expire
← Back to Search
Device
Endovascular Repair for Aortic Aneurysm
N/A
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Inability or refusal to give informed consent by the patient or a legally authorized representative
Uncorrectable coagulopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying different types of devices that can be used to fix an aortic aneurysm. There are three different groups of patients in this study, each with a different type of aneurysm. The first group has an aneurysm that requires a custom-made device. The second group has an aneurysm that requires a branched or fenestrated device. The third group has an aneurysm in the aortic arch.
Who is the study for?
This trial is for adults with specific types of aortic aneurysms (bulges in the wall of the artery) that are at risk of rupture and not suitable for standard treatment. Candidates must have anatomy compatible with custom-made or off-the-shelf stent-grafts, be able to follow up, and consent to participate. Pregnant individuals, those with recent procedures or participation in other trials, severe allergies to contrast material, certain infections or connective tissue disorders are excluded.Check my eligibility
What is being tested?
The study tests endovascular repair devices on three groups: one using custom devices for juxtarenal/suprarenal/type IV thoracoabdominal aneurysms; another for type I-III thoracoabdominal aneurysms needing branched/fenestrated devices; and a third group treated with patient-specific stent-grafts for aortic arch aneurysms.See study design
What are the potential side effects?
Potential side effects may include complications from the implantation procedure such as bleeding or infection, allergic reactions to materials used in the stent-graft or contrast dye during imaging studies, damage to blood vessels where the device is placed, and radiation exposure from x-ray imaging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I cannot or will not give my consent to participate.
Select...
I have a blood clotting disorder that cannot be corrected.
Select...
I have a large aneurysm in my chest or abdomen.
Select...
My veins are not suitable for the needed medical procedure.
Select...
I have an aneurysm in both my chest and upper spine area.
Select...
I am under 18 years old.
Select...
I have a fungal infection in my artery or an active infection throughout my body.
Select...
I cannot have surgery for a pathway in my hip area due to poor access.
Select...
My body can accommodate a specific device for my heart surgery.
Select...
My aneurysm has grown by at least 0.5 cm in a year.
Select...
I have a leaking or ruptured aneurysm with low blood pressure.
Select...
My body's structure doesn't allow for the use of the specific medical device due to blockage or small size.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate effectiveness endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices.
Aortic Aneurysm
Secondary outcome measures
Number of Major adverse events
Number of participants with adverse events from the use of bare metal stents as a measure of safety
Rate of Grafts deployed at intended site with successful and patent stenting of target vessels (technical success)
Other outcome measures
Number of participants with adverse events from radiation exposure as a measure of tolerability.
Rate of complications not considered as major (Secondary safety endpoints)
Medical Devices
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Type I - III TAAA cohortExperimental Treatment1 Intervention
Patients enrolled in this arm will be implanted with the custom made/ off-the-shelfp branched devices. The device is aimed to treat type I-III TAAAs.
Group II: Fenestrated CMD cohortExperimental Treatment1 Intervention
Patients enrolled in this arm will be implanted with the custom made fenestrated device. The device is aimed to treat complex abdominal aortic aneurysms including juxtarenal, suprarenal and type IV thoracoabdominal aneurysms.
Group III: Arch cohortExperimental Treatment1 Intervention
Patients enrolled in this arm will be implanted with patient-specific stent-grafts with one to three inner branches or a scallop.
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,174 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot or will not give my consent to participate.I have a blood clotting disorder that cannot be corrected.My aortic dissection does not meet the specific trial criteria.I have a large aneurysm in my chest or abdomen.You have known allergies to certain materials.My aortic arch condition does not meet the specific criteria mentioned.My veins are not suitable for the needed medical procedure.I have an aneurysm in both my chest and upper spine area.I am under 18 years old.I have a fungal infection in my artery or an active infection throughout my body.Your body shape makes it difficult to see your aorta and its branches on an x-ray.You are not expected to live more than 2 years.I cannot have surgery for a pathway in my hip area due to poor access.My body can accommodate a specific device for my heart surgery.My aneurysm has grown by at least 0.5 cm in a year.I have a leaking or ruptured aneurysm with low blood pressure.You do not meet the specific physical requirements for aortic stent-grafts according to the device's instructions.You cannot be treated with the usual endografts that are available for purchase.I haven't had surgery or an interventional procedure in the last 30 days.My aortic aneurysm is at risk of bursting, as determined by my doctor.Your lower aorta doesn't have a certain segment.The location and shape of a blood vessel in your hip area is not suitable for the procedure.I have a connective tissue disorder, but it might still be okay.My body's structure doesn't allow for the use of the specific medical device due to blockage or small size.I need urgent surgery for a ruptured aortic aneurysm.
Research Study Groups:
This trial has the following groups:- Group 1: Fenestrated CMD cohort
- Group 2: Type I - III TAAA cohort
- Group 3: Arch cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research currently have any open enrollment for participants?
"This research, as reported on clinicaltrials.gov, is no longer recruiting patients; the project was originally launched in December 2014 but has not been updated since February 2022. In contrast, there are 153 other studies currently enlisting volunteers."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger