Actively Recruiting
Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices
Led by Andres Schanzer · Updated on 2025-10-22
600
Participants Needed
1
Research Sites
834 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.
CONDITIONS
Official Title
Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have an aortic or aortoiliac aneurysm with diameter 5.5 cm or larger
- Have an aortic or aortoiliac aneurysm with growth of 1.0 cm or more per year, or symptoms indicating need for repair
- Cannot be treated with currently available non-modified approved devices
- Symptomatic and unsafe to wait for a currently available approved device
- At least 18 years old
- Not pregnant or breastfeeding
- Willing and able to comply with five years of follow-up
- Willing and able to provide informed consent
- No systemic or local infection that increases risk of graft infection
- High risk for open surgical repair based on anatomic or physiologic factors such as previous surgeries, ASA Category III or higher, age over 70 years, heart disease, or COPD
You will not qualify if you...
- Cultural objection to receiving blood or blood products
- Allergy or sensitivity to stainless steel, polyester, polypropylene, solder, gold, or nitinol
- Anaphylactic reaction to contrast that cannot be pre-medicated
- Uncorrectable coagulopathy
- Unstable angina with increasing or new symptoms
- Active malignancy with life expectancy less than 2 years
- Life expectancy less than 2 years
- Significant occlusive disease, tortuosity, or calcification preventing endovascular access
- Proximal neck length 25 mm or less
- Proximal neck diameter outside specified ranges for Zenith devices
- Proximal neck angulation more than 60 degrees
- Diameter change over proximal seal zone more than 4 mm
- Proximal seal site with circumferential thrombus or atheroma
- Iliac artery diameter less than 7.0 mm
- Iliac artery distal fixation site diameter over 21 mm or length less than 10 mm
- Non-bifurcated artery segment less than 15 mm
- Artery to be stented with diameter less than 3 mm or more than 10 mm at ostium
- Unable to maintain at least one patent hypogastric artery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UMass Memorial Health Care - University Campus
Worcester, Massachusetts, United States, 01655
Actively Recruiting
Research Team
S
Shauneen Valliere, MSN, NP
CONTACT
A
Andres Schanzer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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