University of Utah PS-IDE: Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms

Cali Johnson

Status: Not yet enrolling

Conditions: Juxtarenal Abdominal Aortic Aneurysm

Treatments: Device: Endovascular Aneurysm Repair with Physician Modified Endograft

Study type: Interventional

Funder types: Other

Identifiers

NCT07065760

00185860

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is ≥ 18 years of age

2. 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)

3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form

4. Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:

   1. An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
   2. Aneurysm with a history of growth > 0.5 cm in 6 months
   3. Saccular aneurysm deemed at significant risk for rupture
   4. Symptomatic aneurysm
   5. Ruptured aneurysm

5. 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.

6. Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.

7. 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.

8. 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.

9. Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.

10. Patient has juxtarenal aortic neck angulation ≤ 60°

11. Target branch vessel diameter ≥ 5 mm.

12. Patient must be willing to comply with all required follow-up exams.

Exclusion criteria

1. Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection
2. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
3. Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
4. Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).
5. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
6. Patient has known allergy or intolerance to stainless steel, nitinol or gold (gold-coated tungsten).
7. Patient has a body habitus that would inhibit X-ray visualization of the aorta
8. Patient has a limited life expectancy of less than 1 year
9. Patient is currently participating in another investigational device or drug clinical trial
10. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
11. Thrombus or excessive calcification within the neck of the aneurysm
12. Branch vessel stenosis ≥ 80%
13. Patient treatable on label with FDA approved EVAR or FEVAR device and can wait for device availability.
14. Subject is willing and eligible to enroll in a manufacturer-sponsored study at the investigational site, or the subject is willing and eligible to participate in a study with a manufacturer-made device at another institution.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Physician Modified Endograft

Experimental group

Description:

Surgical procedure to repair the juxtarenal abdominal aortic aneurysm, during which the physician-modified endovascular graft (PMEG) device will be used.

Treatment:

Device: Endovascular Aneurysm Repair with Physician Modified Endograft