Actively Recruiting
Repair of Thoracoabdominal Aortic Aneurysms
Led by The Christ Hospital · Updated on 2024-02-08
15
Participants Needed
1
Research Sites
613 weeks
Total Duration
On this page
Sponsors
T
The Christ Hospital
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
CONDITIONS
Official Title
Repair of Thoracoabdominal Aortic Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has an aneurysm with maximum diameter greater than 5.5 cm or twice the normal diameter proximal to the aneurysm
- Patient has an aneurysm that grew more than 0.5 cm in 6 months
- Patient has a saccular aneurysm at significant risk for rupture
- Patient has a symptomatic aneurysm greater than 4.5 cm
- Patient has compatible axillary or brachial and iliac or femoral vessel anatomy for vascular access
- Proximal landing zone for the thoracic bifurcation stent graft with at least 2.5 cm of nonaneurysmal aortic segment distal to the left subclavian artery, diameter 26-42 mm
- Adequate distance from the celiac artery for device cannulation
- Minimum branch vessel diameter of at least 5 mm
- Iliac artery or aortic distal fixation site at least 15 mm in length and diameter 8-25 mm
- Patient is 18 years of age or older
- Patient has a life expectancy longer than 1 year
You will not qualify if you...
- Patient is a good candidate for and chooses open surgical repair
- Patient can be treated with an FDA-approved endovascular prosthesis according to instructions
- Patient is eligible for enrollment in another manufacturer-sponsored IDE at the site
- Patient is unwilling or unable to comply with follow-up schedule
- Patient refuses or cannot give informed consent
- Patient requires urgent or emergency treatment
- Patient is pregnant or breastfeeding
- Patient has a contained or ruptured aneurysm
- Patient has a dissection in the treated aorta portion
- Patient has obstructive stenting of visceral vessels
- Patient has poor performance status with two major system failures
- Patient has allergies to device materials like nitinol, polyester, or stainless steel
- Patient has hypersensitivity to anticoagulation or contrast media that cannot be managed
- Patient has uncorrectable coagulopathy
- Patient's body size inhibits x-ray visualization or exceeds equipment capacity
- Patient had major surgery unrelated to aneurysm treatment within 30 days before repair
- Patient has unstable angina
- Patient has infection increasing risk of graft infection
- Patient has baseline creatinine greater than 2.0 mg/dL
- Patient has connective tissue disorders such as Marfan or Ehler's Danlos syndromes
- Patient has thrombus or excessive calcification in aneurysm neck
- Patient anatomy does not allow maintaining at least one patent hypogastric artery
- Patient anatomy does not allow primary or assisted patency of left subclavian artery
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
G
Geoffrey Answini, MD
CONTACT
D
Darlene Rock
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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