Actively Recruiting
Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic
Led by University of Washington · Updated on 2024-09-19
290
Participants Needed
1
Research Sites
834 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An investigator-initiated, prospective, consecutively enrolling, non-randomized single institution clinical evaluation of the safety and effectiveness of branched and fenestrated-branched endovascular stent grafts to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic aneurysms. The study evaluates non-FDA-approved off the shelf and custom made branched and fenestrated-branched stent grafts manufactured by Cook Medical. The primary objectives of this study are to determine whether fenestrated-branched and branched endovascular grafts are a safe and effective method of treating patients with thoraco-abdominal aortic aneurysms.
CONDITIONS
Official Title
Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is over 18 years of age
- Male or non-pregnant female with a negative pregnancy test if of childbearing potential
- Signed informed consent approved by the Institutional Review Board
- Considered high risk for open surgery due to major medical conditions with ASA score of 3 or higher
- Life expectancy greater than 1 year
- Thoraco-abdominal aortic aneurysm involving necessary visceral branch vessels
- Aneurysm size greater than 5.5 cm, or increased by 0.5 cm in the last 6 months, or causing symptoms
- Sufficient arterial access for device delivery
- Suitable proximal and distal arteries for fixation and seal with specified size requirements
- No more than 5 visceral arteries needing flow preservation
- All target visceral artery seal zones larger than 4 mm in diameter
- Willingness to comply with all follow-up exams
You will not qualify if you...
- Active systemic infection
- Presence of a mycotic aneurysm
- Known hypersensitivity to contrast media not treatable
- Absolute contraindication to anticoagulation
- Allergy to stainless steel, nickel, or gold
- Body size preventing adequate X-ray visualization of the aorta
- Dominant spinal artery arising from stent graft coverage area that cannot be preserved
- Participation in another investigational device or drug trial
- Other medical, social, or psychological conditions preventing treatment or evaluations
- Freely ruptured aneurysm with hemodynamic instability
- Unstable angina or recent major surgery unrelated to aneurysm treatment within 30 days
- History of connective tissue disorders such as Marfan or Ehlers Danlos syndromes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Washington/Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
S
Sandra Mata-Diaz, MPH
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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