Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05800743 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Evaluation of the GORE® Ascending Stent Graft

Study acronym: ARISEII
StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 40 to 41v25
  2. Study sites: 39 to 40v24
  3. Re-verified, no change to tracked fieldsv23
  4. Study sites: 38 to 39v22
  5. Study sites: 36 to 38v21
Show 19 earlier versionsHide 19 earlier versions
  1. Re-verified, no change to tracked fieldsv20
  2. Study sites revised (36)v19
  3. Study sites: 34 to 36
    • Eligibility criteria shortened, about 4 words
    v18
  4. Study sites: 29 to 34v17
  5. Re-verified, no change to tracked fieldsv16
  6. Study sites: 27 to 29v15
  7. Study sites: 20 to 27v14
  8. Study sites: 18 to 20v13
  9. Study sites: 14 to 18v12
  10. Study sites: 10 to 14v11
  11. Study sites: 6 to 10v10
  12. Study sites: 4 to 6
    • Eligibility criteria revised
    v9
  13. Study sites: 3 to 4v8
  14. Study sites: 1 to 3v7
  15. Trial status: Not Yet Recruiting to Enrolling by Invitationv6 Show 4 more changesShow less
    • Start date changed from estimate of Nov 2023 to Nov 28, 2023
    • Interventions: GORE® Ascending Stent Graft (ASG device) (Device), GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) (Device), Surgery (Procedure) to GORE® Ascending Stent Graft (ASG device) (Device), GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device) (Device)…
    • Secondary endpoints revised (2)
    • Site contact updated
  16. Eligibility criteria revised
    • Site contact updated
    v5
  17. Study sites: 0 to 1
    • Start date: Oct 2023 to Nov 2023
    • Secondary endpoints: 1 to 2
    • Eligibility criteria shortened, about 1 word
    v4
  18. Secondary endpoints: details revised at 1 of 1 entryv3
  19. Primary endpoints revised (2)
    • Secondary endpoint revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.
Trial Details
NCT Number NCT05800743
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Aortic Aneurysm, Thoracic, Pseudoaneurysm, Aortic Dissection, Aorta; Lesion
Related terms Aneurysm, False, Aortic Aneurysm, Thoracic, Aortic Dissection
Enrollment 370 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov