PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts

Conditions
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Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm

Intervention / Treatment
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* Device: PMEG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Male or female, aged ≥18 years Expected survival beyond 1 year following successful aneurysm repair 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 Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection Adequate proximal zone of fixation Adequate distal zone of fixation No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary Exclusion Criteria: Moderate-to-severe aortic neck calcification, thrombus, or tortuosity Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit Proximal landing within zone 0 or 1 Inability to maintain at least one patent hypogastric artery Freely ruptured aneurysm with hemodynamic instability Non-ambulatory status Severe CHF Baseline eGFR < 30ml/min, unless currently on or to be initiating dialysis Unstable angina Stroke or MI within 3 months of planned treatment date Active systemic infection and/or mycotic aneurysm Uncorrectable coagulopathy or other bleeding diathesis Known allergy to device material or contrast material that cannot be adequately pre-medicated Body habitus that would preclude adequate fluoroscopic visualization of aorta Pregnancy or lactation (confirmed per standard of care surgical practice) Major, unrelated surgical procedure planned ≤30 days from endovascular repair Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physician-modified endografts<br>For this clinical protocol, endografts which are commercially available will be modified in a sterile fashion on a back-table in the operating room. | Device: PMEG<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with 30-day major adverse events from primary procedure | 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 | Day 30 | 
| Number of subjects with treatment success | 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. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with mortality, major adverse events, spinal cord ischemia | 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. | Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 | 
| Number of subjects with treatment success and freedom from secondary intervention | 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. | Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60 |