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MBA Early Feasibility Study

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 2 to 3
  2. Recruitment opened Show 8 more changesShow less
    • Primary completion moved earlier from Nov 2029 to Aug 2028
    • Lead sponsor: W.L.Gore & Associates to W.L.Gore & Associates
    • Primary endpoints: details revised at 1 of 2 entries
    • Study completion moved earlier from Nov 2034 to Aug 2033
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 2026 to Sep 2, 2026
    • Eligibility criteria expanded, about 54 words
    • Study description expanded, about 2 words
  3. Study description revisedv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 MBA 25-04 study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to assess the initial safety of the MBA device through five years following the index endovascular procedure.
Trial Details
NCT Number NCT07564375
Lead Sponsor W.L.Gore & Associates
Collaborators: NAMSA
Conditions
(from sponsor)		 Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs), Thoracic Aortic Dissection, Pseudoaneurysm
Related terms Aneurysm, False, Aortic Aneurysm, Thoracic, Dissection, Thoracic Aorta, Penetrating Atherosclerotic Ulcer
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov