The purpose of this study is to assess the effects of a physician-modified endovascular graft (PMEG) for juxtarenal aortic aneurysms by collecting data on its performance. Participants in the study will undergo surgery to repair their juxtarenal aortic aneurysm using the PMEG device. After the surgery, participants will attend several follow-up visits to monitor their recovery and the device's effectiveness. These follow-up visits will take place at hospital discharge, then at 1 month, 6 months, 12 months, and once a year for up to 5 years after surgery.
A juxtarenal aortic aneurysm is an aneurysm that occurs near the renal arteries, which bring blood to the kidneys. This research study will evaluate if the physician-modified endovascular graft (PMEG) is safe and effective in the treatment of juxtarenal aortic aneurysms. The PMEG device is an investigational device, which means it has not been approved by the FDA. The device is designed to create a pathway through the aneurysm for blood flow to the arteries, reducing the blood pressure that the aneurysm experiences. There are several types of endovascular devices depending on how big the aneurysm is, where the aneurysm is located in relation to the kidney, or other physical measurements of the blood vessels. The upper portion of the device, or stent graft, will include between one and four holes (fenestrations). The holes allow the device to be located above the renal arteries (the blood vessels that supply blood to the kidneys) without blocking the blood flow to them. Smaller grafts are then placed in the blood vessels to the kidneys, the intestines, and liver to be connected to the main aortic graft, allowing blood to flow to the organs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The surgeon will make an incision to access the femoral artery and insert a thin wire to guide the catheter to the juxtarenal aortic aneurysm. The main graft will be modified by hand to match the participant's anatomy, then reloaded and guided through the artery to the aorta. Once in place, the graft will be deployed, and additional stents will be inserted into vital arteries that supply the kidneys and bowels. Two smaller grafts will be placed into the iliac arteries.This allows blood to flow to the target organs and legs, protecting the aneurysm from rupture. All catheters will then be removed, leaving the graft in place, and the incisions will be closed.
University of Utah Hospital
Salt Lake City, Utah, United States
All Cause Mortality
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including all-cause mortality.
Time frame: 30 days post index procedure
Myocardial Infarction
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including myocardial infarction.
Time frame: 30 days post index procedure
Stroke
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including stroke.
Time frame: 30 days post index procedure
Renal Failure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including renal failure.
Time frame: 30 days post index procedure
Respiratory Failure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including respiratory failure.
Time frame: 30 days post index procedure
Paraplegia
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including paraplegia.
Time frame: 30 days post index procedure
Bowel Ischemia
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including bowel ischemia.
Time frame: 30 days post procedure
Procedural Blood Loss (>1000 cc)
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including procedural blood loss (\>1000 cc).
Time frame: 30 days post procedure
Treatment Success
The primary effectiveness endpoint is the proportion of subjects that achieve Treatment Success. Treatment Success is a composite endpoint assessed at 12 months that requires the following criteria to be met: Technical Success (at the index procedure) is defined by the following: 1. The physician was able to insert the delivery catheter and deliver the physician modified endovascular graft to the treatment site and preserve blood flow into the vessels intended to have blood flow preserved. 2. Freedom from Type I \& III endoleaks at 12 months 3. Freedom from stent graft migration at 12 months 4. Freedom from aortic aneurysm enlargement at 12 months 5. Freedom from aortic aneurysm rupture and conversion to open repair through 12 months
Time frame: 12 months post index procedure
Mortality
Secondary safety endpoints will be evaluated at 30 days, 6 months, \& 12 months following the initial implant procedure and annually through 5 years, including mortality.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure
Aneurysm related mortality
Secondary safety endpoints will be evaluated at 30 days, 6 months, \& 12 months following the initial implant procedure and annually through 5 years, including aneurysm related mortality.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure
Aneurysm Rupture
Secondary safety endpoints will be evaluated at 30 days, 6 months, \& 12 months following the initial implant procedure and annually through 5 years, including aneurysm rupture.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure.
Major Adverse Events (MAE)
Secondary safety endpoints will be evaluated at 30 days, 6 months, \& 12 months following the initial implant procedure and annually through 5 years, including major adverse events.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure
Renal failure with or without permanent dialysis
Secondary safety endpoints will be evaluated at 30 days, 6 months, \& 12 months following the initial implant procedure and annually through 5 years, including renal failure with or without permanent dialysis.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure.
Graft Infection
Secondary safety endpoints will be evaluated at 30 days, 6 months, \& 12 months following the initial implant procedure and annually through 5 years, including graft infection.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure.
Technical Success
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Secondary effectiveness endpoints will be evaluated including technical success. Technical Success (evaluated at 30-days) is a composite of the following: a. Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits; b. Successful delivery and deployment at the intended implantation site; c. Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels; d. Successful withdrawal of the delivery system; e. Patency of all endovascular graft and stent components; f. Absence of device deformations requiring unplanned placement of an additional device; g. Absence of Type I and III endoleaks at completion angiography that extends beyond 30 days by confirmatory imaging
Time frame: 30 days, 6 months, and annually through 5 years post index procedure
Stent graft migration > 10 mm
Secondary effectiveness endpoints will be evaluated including stent graft migration \> 10 mm.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure.
All endoleaks
Secondary effectiveness endpoints will be evaluated including all endoleaks.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure.
AAA enlargement
Secondary effectiveness endpoints will be evaluated including AAA enlargement.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure.
Patency related events
Secondary effectiveness endpoints will be evaluated including patency related events.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure.
Device integrity failure
Secondary effectiveness endpoints will be assessed including device integrity failure.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure.
Conversion to open repair
Secondary effectiveness endpoints will be evaluated including conversion to open repair.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure.
Secondary Intervention
Secondary effectiveness endpoints will be evaluated including secondary interventions.
Time frame: 30 days, 6 months, and annually through 5 years post index procedure.