Actively Recruiting
Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
Led by Darren Schneider, M.D. · Updated on 2025-12-15
520
Participants Needed
2
Research Sites
1047 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.
CONDITIONS
Official Title
Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men with TAAA greater than or equal to 6 cm in diameter
- Women with TAAA greater than or equal to 5 cm in diameter
- Men with TAAA larger than 5 cm and enlarging over 10 mm/year
- Women with TAAA larger than 4.5 cm and enlarging over 10 mm/year
- Men or women with TAAA and iliac artery aneurysm larger than or equal to 4 cm
- Life expectancy more than 2 years
- Ability to provide informed consent and comply with follow-up
- Suitable arterial anatomy for endovascular TAAA repair including specific vessel size and condition criteria
- Patients at high risk for open repair due to age, cardiac, pulmonary, renal disease, prior surgery, or other listed conditions
- Men with aortic arch aneurysm greater than or equal to 6 cm
- Women with aortic arch aneurysm greater than or equal to 5 cm
- Men with aortic arch aneurysm larger than 5 cm and enlarging over 10 mm/year
- Women with aortic arch aneurysm larger than 4.5 cm and enlarging over 10 mm/year
- Saccular aortic arch aneurysms at significant risk of rupture
- Life expectancy more than 2 years
- Ability to provide informed consent and comply with follow-up
- Suitable arterial anatomy for endovascular aortic arch repair including specific vessel size and condition criteria
- Patients at high risk for open aortic arch repair based on surgical and medical criteria
You will not qualify if you...
- Rupture with low blood pressure (systolic < 90)
- Pregnancy or breastfeeding
- Inability or unwillingness to follow the study schedule
- Serious systemic or groin infection
- Uncorrectable blood clotting disorders
- Age under 18 years
- Mycotic (infected) aneurysm
- Known connective tissue diseases like Marfan or Ehler-Danlos (unless prior graft implanted)
- Allergies to device materials such as stainless steel, nitinol, polyester, solder, polypropylene, urethane, or gold
- Participation in another investigational study within 1 year
- Major unrelated surgery within 30 days before treatment
- Body size or shape that prevents clear X-ray imaging of the aorta
- Acute aortic dissection
- Candidates suitable for commercially available or manufacturer-sponsored devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
New York Presbyterian Hospital
New York, New York, United States, 10022
Active, Not Recruiting
2
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
D
Darren Schneider, MD
CONTACT
K
Kiera Zehner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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