Status:
SUSPENDED
Physician-modified Endovascular Graft for Repair of Complex Thoracoabdominal and Abdominal Aortic Aneurysms
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Juxtarenal Aortic Aneurysm
Suprarenal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms ...
Detailed Description
This study is a prospective, single-center, non-randomized, single-arm study. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, computed tomography angiograph...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Life expectancy \> 2 year(s)
- Patient is considered to be at high risk of morbidity and mortality with open surgical repair
- A patient may be entered into the study if the patient has at least one of the following:
- Juxtarenal, suprarenal or a thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter
- Aneurysm with a history of growth ≥ 0.5 cm per year
- Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation
- Symptomatic juxtarenal, suprarenal or a thoracoabdominal aortic aneurysm
- Thoracoabdominal aortic aneurysms secondary to aortic dissection meeting above criteria
- Patient is considered to be at high risk of morbidity and mortality with open surgical repair
- Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
- Nonaneurysmal aortic segment proximal to the aneurysm (neck) with a:
- Minimum neck length of 20mm
- Diameter in the range of 21-38mm
- Angle less than 60° relative to the axis of the aneurysm
- Angle less than 60° relative to the axis of the suprarenal aorta
- Minimum branch vessel diameter greater than 5 mm
- Iliac artery distal fixation site greater than 10mm in length and diameter in the range of 8-21mm.
Exclusion
- Under the age of 18 years
- Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
- Willing to participate in a sponsor-investigator IDE with access to a non-physician modified endovascular prostheses at the investigational site
- Willing to travel to an investigational site with access to a non-physician modified endovascular prosthesis
- Unwilling or unable to comply with the follow-up schedule
- Inability or refusal to give informed consent by patient or legal representative
- Patient is pregnant or breastfeeding
- Life expectancy \< 2-years despite successful aneurysm exclusion
- Free rupture with hemodynamic instability
- Ongoing infection
- Diagnosis of, or suspected connective tissue disease
- Known sensitivities or allergies to the materials of construction of the devices
- Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
- Uncorrectable coagulopathy
- Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
- Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
- Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
- Systemic or local infection that may increase the risk of endovascular graft infection
- Leaking or free rupture of aneurysm associated with hemodynamic instability.
- Baseline creatinine greater than 3.0 mg/dL
- Known history of, or suspected connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
- Anatomical exclusion criteria:
- Inadequate femoral or iliac access compatible with the required delivery systems, not amenable to open surgical or endovascular conduit placement
- Absence of a non-aneurysmal aortic segment for proximal seal zone with:
- A diameter measured outer wall to outer wall of no greater than 38mm and no less than 21 mm;
- Parallel aortic wall with \<20% diameter change and without significant calcification and/or thrombus in the selected area of seal zone
- Visceral vessel anatomy not compatible with physician-modified Zenith® Alpha Endovascular Graft due to excessive occlusive disease or small size not amenable to stent graft placement
- Unsuitable distal iliac artery fixation site and anatomy:
- Common iliac artery fixation site diameter measured outer wall to outer wall on a sectional image (CT) \<8.0 mm with inability to perform open surgical conduit
- Iliac artery diameter measured outer wall to outer wall on a sectional image (CT) \>21 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft
- Iliac artery distal fixation site \<10 mm in length
- Inability to preserve at least one hypogastric artery
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04526938
Start Date
September 20 2021
End Date
September 1 2028
Last Update
August 29 2025
Active Locations (1)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010