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Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date changed from estimate of Jan 2024 to Jan 31, 2024
    • Study site revised
    • Collaborators expanded, about 2 words
    v12
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v11
  3. Enrollment target: 100 to 250
    • Primary completion date: Jan 2022 to Jan 2024
    • Study completion date: Dec 2024 to Dec 2029
    v10
  4. Primary completion date: Dec 2019 to Jan 2022v9
  5. Enrollment target: 25 to 100v8 Show 4 more changesShow less
    • Primary completion date: Dec 2017 to Dec 2019
    • Study completion date: Dec 2022 to Dec 2024
    • Eligibility criteria expanded, about 113 words
    • Study description expanded, about 104 words
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Feb 2017 to Dec 2017
    • Study completion date: Feb 2022 to Dec 2022
    • Eligibility criteria expanded, about 41 words
    v7
  2. Enrollment target: 15 to 25v6 Show 4 more changesShow less
    • Interventions: TAAA Debranching Stent Graft (Device) to Unitary Manifold (Device), Visceral Manifold and Thoracic Bifurcation (Device)
    • Eligibility criteria expanded, about 215 words
    • Study arms: 1 to 2
    • Study title expanded, about 3 words
  3. Eligibility criteria shortened, about 8 words
    • Site contact updated
    v5
  4. Eligibility criteria expanded, about 7 wordsv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  6. Enrollment target: 15v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Trial Details
NCT Number NCT02294435
Lead Sponsor Sanford Health
Collaborators: Dakota Vascular
Conditions
(from sponsor)		 Thoracoabdominal Aneurysms
Related terms Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Thoracic, Aortic Diseases, Aortic Dissection, Cardiovascular Diseases, Vascular Diseases
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov