Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06657794

Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms

Led by The Cleveland Clinic · Updated on 2025-06-24

15

Participants Needed

1

Research Sites

306 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18 years of age or older
  • Patient is male or non-pregnant female (females of childbearing potential must have a negative pregnancy test before enrollment)
  • Patient or legally authorized representative has signed an IRB-approved informed consent form
  • Patient has a juxtarenal abdominal aortic aneurysm meeting at least one of the following: maximum diameter ≥ 5.5 cm for males or ≥ 5.0 cm for females, aneurysm growth > 0.5 cm in 6 months, saccular aneurysm at significant risk for rupture, symptomatic aneurysm, or ruptured aneurysm
  • Patient has patent iliac or femoral arteries allowing endovascular access with the modified graft
  • Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm below the most distal renal artery ostium
  • Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm preserving patency in at least one hypogastric artery
  • Patient has a suitable proximal aortic neck diameter between 20 and 32 mm averaged at specified locations
  • Patient has suitable distal common iliac diameters between 8 and 20 mm
  • Patient has juxtarenal aortic neck angulation ≤ 60°
  • Target branch vessel diameter ≥ 5 mm
  • Patient is willing to comply with all required follow-up exams
Not Eligible

You will not qualify if you...

  • Patient has a mycotic aneurysm or active systemic or local infection increasing risk of endovascular infection
  • Patient has unstable angina with recent worsening symptoms or new onset at rest or night
  • Patient has a major surgical or interventional procedure planned within ±30 days of the aneurysm repair
  • Patient has a history of aortopathic connective tissue disease such as Marfan's or Ehler's-Danlos syndrome
  • Patient has known hypersensitivity or contraindication to anticoagulation or contrast media not manageable by pre-treatment
  • Patient has known allergy or intolerance to stainless steel, nitinol, or gold (gold-coated tungsten)
  • Patient has a body habitus that prevents adequate X-ray visualization of the aorta
  • Patient has a life expectancy less than 1 year
  • Patient is currently participating in another investigational device or drug trial
  • Patient has medical, social, or psychological conditions that preclude treatment and evaluations
  • Patient has thrombus or excessive calcification within the aneurysm neck
  • Patient has branch vessel stenosis ≥ 80%
  • Patient can be treated on-label with existing FDA-approved devices and can wait for device availability
  • Patient is willing and eligible to enroll in manufacturer-sponsored studies at the site or elsewhere

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

Y

Yuki Kuramochi, BSN, RN

CONTACT

J

Jeannine Ramsey, BSN, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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