Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms (PMEG)

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

The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device:

• acutely (i.e., treatment success and technical success);
• at 30 days (i.e., the rate of major adverse events (MAE)); and
• at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).

Study Overview

• Status: Recruiting
• Conditions: Aortic Rupture; Juxtarenal Aortic Aneurysm
• Intervention / Treatment: Device: Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system

Detailed Description

The primary objective of the clinical investigation Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuki Kuramochi, BSN, RN; Phone Number: 216-445-4063; Email: kuramoy@ccf.org
• Study Contact Backup: Name: Jeannine Ramsey, BSN, RN; Email: RAMSEYJ8@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Principal Investigator: Francis Caputo, MD
      • Contact: Yuki Kuramochi, BSN, RN; Email: kuramoy@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

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:

Patients that meet ANY of the following are not eligible for enrollment into the study:

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 pretreatment, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system

Device: Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system; A Physician Modified Endograft is a commercially available, off-the-shelf endograft that has been altered at the time of the procedure by creating fenestrations in the seal zone of the graft to preserve blood flow into vital branch vessels. These fenestrations are marked with medical grade gold markers to facilitate fluoroscopic visualization during the procedure. In order to prevent branch vessel occlusion, these branch vessels are typically stented with covered balloon expandable stents using standardized techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Events	The proportion of patients that experience a rate of Major Adverse Events	Up to 30 days
Effectiveness	Technical Success, defined as successful delivery and deployment of the physician modified endovascular graft with preservation of those branch vessels intended to be preserved.; Freedom from Type I & III endoleaks; Freedom from stent graft migration; Freedom from abdominal aortic aneurysm enlargement; Freedom from Aortic aneurysm rupture and conversion to open repair	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of the safety events	Mortality; Aneurysm related mortality; Aneurysm rupture; Major Adverse Events; Renal failure with or without permanent dialysis; Graft infection	Up to 5 years
Technical Success	Technical Success is a composite of the following: Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits; Successful delivery and deployment at the intended implantation site; Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels; Successful withdrawal of the delivery system; Patency of all endovascular graft and stent components; Absence of device deformations requiring unplanned placement of an additional device; Absence of Type I and III endoleaks at completion angiography	Up to 30 days
Stent Graft Migratoin	Occurrence of stent graft migration >10 mm	Up to 5 years
All Endoleaks	Occurrence of endoleaks (all types, including Type I and III)	Up to 5 years
AAA Enlargement	Occurrence of AAA enlargement	Up to 5 years
Patency Related Events	Occurrence of patency related events	Up to 5 years
Device Integrity Failure	Occurrence of device integrity failure	Up to 5 years
Conversion to Open Repair	Occurrence of Conversion to open repair	Up to 5 years
Secondary Intervention	Occurrence of Secondary intervention (reason and type)	Up to 5 years

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Study Chair: Sean P Lyden, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Aortic Diseases; Aneurysm, Ruptured; Rupture; Aneurysm; Aortic Aneurysm; Aortic Rupture
• Other Study ID Numbers: 25-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes