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

Official title

Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms

Overview

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.

Detailed 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.

Interventions

• Device Endovascular Aneurysm Repair with Physician Modified Endograft
  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 t

Primary outcome measures

• All Cause Mortality [Time frame: 30 days post index procedure]
• Myocardial Infarction [Time frame: 30 days post index procedure]
• Stroke [Time frame: 30 days post index procedure]
• Renal Failure [Time frame: 30 days post index procedure]
• Respiratory Failure [Time frame: 30 days post index procedure]
• Paraplegia [Time frame: 30 days post index procedure]
• Bowel Ischemia [Time frame: 30 days post procedure]
• Procedural Blood Loss (>1000 cc) [Time frame: 30 days post procedure]
• Treatment Success [Time frame: 12 months post index procedure]

Secondary outcome measures (12)

• Mortality [Time frame: 30 days, 6 months, and annually through 5 years post index procedure]
• Aneurysm related mortality [Time frame: 30 days, 6 months, and annually through 5 years post index procedure]
• Aneurysm Rupture [Time frame: 30 days, 6 months, and annually through 5 years post index procedure.]
• Major Adverse Events (MAE) [Time frame: 30 days, 6 months, and annually through 5 years post index procedure]
• Renal failure with or without permanent dialysis [Time frame: 30 days, 6 months, and annually through 5 years post index procedure.]
• Graft Infection [Time frame: 30 days, 6 months, and annually through 5 years post index procedure.]
• Technical Success [Time frame: 30 days, 6 months, and annually through 5 years post index procedure]
• Stent graft migration > 10 mm [Time frame: 30 days, 6 months, and annually through 5 years post index procedure.]
• All endoleaks [Time frame: 30 days, 6 months, and annually through 5 years post index procedure.]
• AAA enlargement [Time frame: 30 days, 6 months, and annually through 5 years post index procedure.]
• Patency related events [Time frame: 30 days, 6 months, and annually through 5 years post index procedure.]
• Device integrity failure [Time frame: 30 days, 6 months, and annually through 5 years post index procedure.]

Eligibility criteria

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:

• 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
• Aneurysm with a history of growth > 0.5 cm in 6 months
• Saccular aneurysm deemed at significant risk for rupture
• Symptomatic aneurysm
• Ruptured aneurysm
• 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

• Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection
• 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)
• Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
• Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).
• Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
• Patient has known allergy or intolerance to stainless steel, nitinol or gold (gold-coated tungsten).
• Patient has a body habitus that would inhibit X-ray visualization of the aorta
• Patient has a limited life expectancy of less than 1 year
• Patient is currently participating in another investigational device or drug clinical trial
• 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.
• Thrombus or excessive calcification within the neck of the aneurysm
• Branch vessel stenosis ≥ 80%
• Patient treatable on label with FDA approved EVAR or FEVAR device and can wait for device availability.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Utah Hospital — Salt Lake City

Identifiers

NCT: NCT07065760 · 00185860

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗