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Thoraflex Hybrid and Relay Extension Post-Approval Study

Study acronym: EXTEND
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv9 Show 4 more changesShow less
    • Enrollment target: estimated 200 to confirmed 352
    • Primary completion date: Dec 2035 to Jul 2035
    • Study completion date: Dec 2036 to Mar 2036
    • Site details revised at 27 of 27 sites
  2. Primary endpoints: 4 to 2
    • Study sites: 25 to 27
    v8
  3. Site contacts updated at 25 of 25 sitesv7
  4. Study sites: 17 to 25v6
  5. Study sites: 15 to 17v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 13 to 15v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 13
    • Start date changed from estimate of Mar 2023 to Mar 17, 2023
    v3
  3. Start date: Dec 2022 to Mar 2023
    • Study sites: 1 to 2
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Vascutek Ltd.
7 trials monitored
See 1 trial at risk
The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site. Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.
Trial Details
NCT Number NCT05639400
Lead Sponsor Vascutek Ltd.
Collaborators: Bolton Medical
Conditions
(from sponsor)		 Thoracic Diseases, Aortic Aneurysm, Aortic Dissection, Thoracic Aortic Aneurysm, Thoracic Aortic Dissection
Related terms Aortic Aneurysm, Aortic Aneurysm, Thoracic, Aortic Dissection, Dissection, Thoracic Aorta, Thoracic Diseases
Enrollment 352 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov