Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Conditions
Brief summary
The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.
Interventions
DEVICEPMEG
All devices that will be modified in this study protocol are commercially available in the United States. The commercially available endografts will be used to construct a fenestrated/branched device for this intervention.
Sponsors
Konstantinos Dean Arnaoutakis, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form 2. Male or female, aged ≥18 years 3. Expected survival beyond 1 year following successful aneurysm repair 4. Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and/or renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length 5. Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection 6. Adequate proximal zone of fixation 7. Adequate distal zone of fixation 8. No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm 9. Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary
Exclusion criteria
1. Moderate-to-severe aortic neck calcification, thrombus, or tortuosity 2. Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit 3. Proximal landing within zone 0 or 1 4. Inability to maintain at least one patent hypogastric artery 5. Freely ruptured aneurysm with hemodynamic instability 6. Non-ambulatory status 7. Severe CHF 8. Baseline eGFR \< 30ml/min, unless currently on or to be initiating dialysis 9. Unstable angina 10. Stroke or MI within 3 months of planned treatment date 11. Active systemic infection and/or mycotic aneurysm 12. Uncorrectable coagulopathy or other bleeding diathesis 13. Known allergy to device material or contrast material that cannot be adequately pre-medicated 14. Body habitus that would preclude adequate fluoroscopic visualization of aorta 15. Pregnancy or lactation (confirmed per standard of care surgical practice) 16. Major, unrelated surgical procedure planned ≤30 days from endovascular repair 17. Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial 18. Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study 19. Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device 20. Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with 30-day major adverse events from primary procedure | Day 30 | Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation \>72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc |
| Number of subjects with treatment success | Month 12 | Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with mortality, major adverse events, spinal cord ischemia | Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 | Mortality includes all-cause mortality. Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation \>72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc. Spinal cord ischemia data will include all incidence and degree of spinal cord ischemia. |
| Number of subjects with treatment success and freedom from secondary intervention | Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 | Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality. Freedom from secondary interventions includes interventions to treat malperfusion, rupture, aneurysm formation, aortic expansion, endoleak, device stenosis/occlusion, or access site complication. |
Countries
United States
Contacts
Primary ContactBeth Montera
Backup ContactKonstantinos Arnaoutakis, MD
Outcome results
None listed