Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physician Modified Endograft | Experimental | Surgical procedure to repair the juxtarenal abdominal aortic aneurysm, during which the physician-modified endovascular graft (PMEG) device will be used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Aneurysm Repair with Physician Modified Endograft | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | 30 days post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days, 6 months, and annually through 5 years post index procedure |
| Aneurysm related mortality |
Not provided
Inclusion Criteria:
Patient is ≥ 18 years of age
Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:
Patient has patent iliac or femoral arteries, with or without the use of conduit, that will allow endovascular access with the physician modified endovascular graft.
Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.
Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15mm. The resultant repair should preserve patency in at least one hypogastric artery.
Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32 mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.
Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
Patient has juxtarenal aortic neck angulation ≤ 60°
Target branch vessel diameter ≥ 5 mm.
Patient must be willing to comply with all required follow-up exams.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Hales, MSN, RN, CCRC | Contact | 801-587-1450 | Julie.Hales@hsc.utah.edu | |
| Cali Johnson, MD, EdD | Contact | 801-213-6585 | cali.johnson@hsc.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cali Johnson, MD, EdD | University of Utah | Principal Investigator |
| Nathan Droz, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Hospital | Recruiting | Salt Lake City | Utah | 84112 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, single center, nonrandomized, single arm study.
Not provided
Not provided
Not provided
Not provided
|
| 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. |
| 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). | 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:
| 12 months post index procedure |
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. |
| 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. | 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. | 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. | 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. | 30 days, 6 months, and annually through 5 years post index procedure. |
| Technical Success | 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 | 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. | 30 days, 6 months, and annually through 5 years post index procedure. |
| All endoleaks | Secondary effectiveness endpoints will be evaluated including all endoleaks. | 30 days, 6 months, and annually through 5 years post index procedure. |
| AAA enlargement | Secondary effectiveness endpoints will be evaluated including AAA enlargement. | 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. | 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. | 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. | 30 days, 6 months, and annually through 5 years post index procedure. |
| Secondary Intervention | Secondary effectiveness endpoints will be evaluated including secondary interventions. | 30 days, 6 months, and annually through 5 years post index procedure. |
| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |
Not provided
Not provided