Actively Recruiting
Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms
Led by Akhilesh Jain · Updated on 2025-08-24
15
Participants Needed
1
Research Sites
360 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk candidates for open surgical repair, have limited or no other options for on label treatment with an FDA approved device, and having appropriate anatomy.
CONDITIONS
Official Title
Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 63 18 years of age
- Male or non-pregnant female (females of childbearing potential must have a negative pregnancy test prior to enrollment)
- Patient or legally authorized representative has signed an Institutional Review Board (IRB) approved informed consent form
- Juxtarenal abdominal aortic aneurysm with at least one of the following: maximum diameter 63 5.5 cm for males (63 5.0 cm for females) or 2 times normal diameter proximal to aneurysm; growth > 0.5 cm in 6 months; saccular aneurysm at significant risk for rupture; symptomatic aneurysm; or ruptured aneurysm
- Patent iliac or femoral arteries allowing endovascular access with the graft
- Suitable non-aneurysmal proximal aortic neck 63 2 mm inferior to most distal renal artery ostium
- Suitable non-aneurysmal distal iliac artery length (seal zone) 63 15 mm preserving at least one hypogastric artery
- Suitable proximal aortic neck diameter between 20 and 32 mm averaged at key arterial points
- Suitable distal common iliac diameters between 8 and 20 mm
- Juxtarenal aortic neck angulation 64 60da
- Target branch vessel diameter 63 5 mm
- Willing to comply with all required follow-up exams
You will not qualify if you...
- Presence of a mycotic aneurysm or active systemic/local infection increasing endovascular infection risk
- Unstable angina with progressive symptoms, new onset at rest or nocturnal angina, or prolonged angina onset
- Major surgical or interventional procedure unrelated to repair planned within �b1 30 days of aneurysm repair
- History of aortopathic connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome)
- Known hypersensitivity or contraindication to anticoagulation or contrast media not amenable to pre-treatment
- Allergy or intolerance to stainless steel, nitiol, or gold (gold-plated tungsten)
- Body habitus that inhibits X-ray visualization of the aorta
- Limited life expectancy of less than 1 year
- Current participation in another investigational device or drug clinical trial
- Medical, social, or psychological conditions precluding treatment or evaluations as judged by investigator
- Thrombus or excessive calcification within aneurysm neck
- Branch vessel stenosis 63 80 %
- Patients treatable with FDA-approved EVAR or FEVAR devices who can wait for device availability
- Willing and eligible to enroll in manufacturer-sponsored or other investigational device studies at any institution
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
Research Team
A
Akhilesh K Jain, MD
CONTACT
V
Vicky McLeod, BS
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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