Actively Recruiting
Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts
Led by University of California, Los Angeles · Updated on 2025-12-15
50
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate safety and effectiveness of endovascular treatment of juxtarenal, pararenal and thoracoabdominal aortic aneurysms (with or without iliac artery involvement) using physician-modified stent grafts with a combination of fenestrations and/or branches.
CONDITIONS
Official Title
Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is considered appropriate for treatment with a physician-modified stent graft
- Patient is high risk for traditional open surgical repair due to physiological or anatomical factors
- Physiological high risk includes age over 75 years, chronic obstructive pulmonary disease, congestive heart failure, previous myocardial infarction, coronary stent or bypass, chronic renal insufficiency with baseline eGFR < 40 ml/min, or ASA score greater than 3
- Anatomical high risk includes prior intraabdominal operations, prior abdominal wall reconstructions, prior radiation therapy targeting abdomen or pelvis, or history of intraabdominal sepsis
- Arm 1: Juxtarenal, pararenal, suprarenal, or extent IV thoracoabdominal aortic aneurysm or dissection with diameter ≥ 5.5 cm or twice normal size, or aneurysm growth ≥ 0.5 cm in one year, or high risk saccular aneurysm, or common iliac artery aneurysm ≥ 3.5 cm or saccular morphology without suitable landing zone
- Arm 2: Extent I, II, or III thoracoabdominal aortic aneurysm or dissection with diameter ≥ 5.5 cm or twice normal size, or aneurysm growth ≥ 0.5 cm in one year, or high risk saccular aneurysm, or common iliac artery aneurysm ≥ 3.5 cm or saccular morphology without suitable landing zone
- Arm 3: Urgent or emergent ruptured, contained ruptured, or symptomatic juxtarenal, pararenal, suprarenal, or thoracoabdominal aortic aneurysm planned for repair within 48 hours, suitable for informed consent and unsuitable for open surgery or other devices
You will not qualify if you...
- Younger than 18 years of age
- Unwilling to comply with follow-up schedule
- Unable or unwilling to give informed consent
- Pregnant or breastfeeding
- Life expectancy less than 2 years
- Prior open surgical or interventional procedure within 30 days before planned stent graft procedure, except planned staged procedures for access or revascularization
- Eligible for FDA-approved device treatment within instructions for use
- Currently enrolled or eligible for other manufacturer-sponsored studies with similar devices
- Participation in other investigational clinical or device trials not allowed unless specified exceptions apply
- Known allergies or sensitivities to device materials including stainless steel, nitinol, polyester, solder, polypropylene, PTFE, urethane, or gold
- History of severe allergic reaction to contrast material not manageable by pre-medication
- Uncorrectable bleeding disorders
- Active systemic infection or mycotic aneurysm
- History of connective tissue disorders except specific conditions as outlined
- Body size or shape that prevents X-ray visualization of aorta and branches
- Inadequate femoral or iliac artery access for device delivery
- Inability to perform temporary or permanent surgical or endovascular access procedures
- Absence of suitable non-aneurysmal aortic segment above diaphragm meeting size and condition requirements
- Visceral vessel anatomy unsuitable for device placement due to disease or size
- Unsuitable distal iliac artery anatomy for device fixation as per instructions for use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
K
Kate M Horiuchi, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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