Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms

NCT06657794 | Recruiting DMC FDA Device

• 1 other identifier: 25-009
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Juxtarenal Aortic Aneurysm; Aortic Rupture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Occurrence of the safety events

  Up to 5 years

• Technical Success

  Up to 30 days

• Stent Graft Migratoin

  Up to 5 years

• All Endoleaks

  Up to 5 years

• AAA Enlargement

  Up to 5 years

Study Arms (1)

Intervention

EXPERIMENTAL

Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system

Device: Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system

Interventions

Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system DEVICE

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.

Intervention

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:

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

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Aortic Rupture

Condition Hierarchy (Ancestors)

Aneurysm, Ruptured; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Aortic Diseases; Rupture; Wounds and Injuries

Study Officials

• Sean P Lyden, MD

  The Cleveland Clinic

  STUDY CHAIR

Central Study Contacts

Yuki Kuramochi, BSN, RN

CONTACT

216-445-4063; kuramoy@ccf.org

Jeannine Ramsey, BSN, RN

CONTACT

RAMSEYJ8@ccf.org

Study Design

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

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 24, 2024
• Study Start: February 17, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)