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Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms

Study acronym: PMEG
StatusWithdrawn
PhaseNot applicable
Started
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Record History

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  1. Stopped Trial status changed: Recruiting → Withdrawn Sponsor's reason: Physician-Sponsor Retirment Show 5 more changesShow less
    • Enrollment target: estimated 15 to confirmed 0
    • Primary completion date changed from estimate of Dec 31, 2030 to Sep 15, 2026
    • Study sites: 1 to 0
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 3 of 9 entries
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Minor Site contact updatedv6
  4. Notable Lead sponsor: [Redacted] to The Cleveland Clinicv5 Show 4 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary and study completion dates: Dec 31, 2030
    • Start date: Feb 17, 2025
    • Study title shortened, about 2 words
  5. Minor 3 versions Re-verified since Dec 19, 2024, no change to tracked fieldsv2-v4
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06657794
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)
Juxtarenal Aortic Aneurysm, Aortic Rupture
Related terms Aortic Rupture
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov