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Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

Study acronym: CARPE-CMD
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv16
  2. Notable Enrollment target: 400 to 600v15
  3. Notable Lead sponsor: University of Massachusetts, Worcester to Andres Schanzerv14
  4. Minor Re-verified, no change to tracked fieldsv13
  5. Minor Enrollment target: 300 to 400v12
Show 10 earlier versionsHide 10 earlier versions
  1. Notable Primary completion date: Mar 2020 to Mar 2030v11 Show 4 more changesShow less
    • Study completion date: Mar 2024 to Mar 2030
    • Interventions: Physician modified stent graft (Device) to Custom Made Fenestrated or Branched Stent Graft (Device)
    • Eligibility criteria shortened, about 32 words
    • Study description shortened, about 15 words
  2. Notable Enrollment target: 200 to 300v10
  3. Notable Enrollment target: 50 to 200
    • Eligibility criteria shortened, about 5 words
    v9
  4. Minor 3 versions Re-verified since Dec 15, 2015, no change to tracked fieldsv6-v8
  5. Notable Enrollment target: 25 to 50
    • Study description expanded, about 207 words
    • Study title expanded, about 4 words
    v5
  6. Minor 2 versions Re-verified since Sep 18, 2014, no change to tracked fieldsv3-v4
  7. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.
Trial Details
NCT Number NCT02050113
Lead Sponsor Andres Schanzer
Conditions
(from sponsor)
Complex Aortic Aneurysms, Thoracoabdominal Aneurysms, Pararenal Aneurysms, Juxtarenal Aneurysms, Marfan Syndrome, Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Aortic Arch Aneurysm
Related terms Aneurysm, Aortic Arch, Aortic Aneurysm, Abdominal, Aortic Dissection, Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Marfan Syndrome
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov