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

NCT07065760 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 00185860
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Juxtarenal Abdominal Aortic Aneurysm

Keywords

physician modified endovascular graft; juxtarenal abdominal aortic aneurysm; PMEG; FEVAR; Endovascular Aortic Repair

Outcome Measures

Primary Outcomes (9)

• 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

• 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: 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

  12 months post index procedure

Secondary Outcomes (14)

• Mortality

  30 days, 6 months, and annually through 5 years post index procedure

• Aneurysm related mortality

  30 days, 6 months, and annually through 5 years post index procedure

• Aneurysm Rupture

  30 days, 6 months, and annually through 5 years post index procedure.

• Major Adverse Events (MAE)

  30 days, 6 months, and annually through 5 years post index procedure

• Renal failure with or without permanent dialysis

  30 days, 6 months, and annually through 5 years post index procedure.

Study Arms (1)

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.

Device: Endovascular Aneurysm Repair with Physician Modified Endograft

Interventions

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.

Physician Modified Endograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cali Johnson: lead

Study Sites (1)

University of Utah Hospital

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

Endovascular Aneurysm Repair

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Cali Johnson, MD, EdD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Nathan Droz, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective, single center, nonrandomized, single arm study.

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 15, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2032
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)