Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03214601 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System

Study acronym: RelayBranch
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv14
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 30
    • Primary completion date changed from estimate of Sep 2023 to Sep 18, 2023
    • Site details revised at 12 of 12 sites
    v13
  3. Re-verified, no change to tracked fieldsv12
  4. Primary completion date: Sep 2022 to Sep 2023
    • Enrollment target: 30 to 40
    • Study completion date: Aug 31, 2024 to Aug 31, 2028
    • Eligibility criteria expanded, about 3 words
    v11
  5. Primary completion date: Sep 2021 to Sep 2022v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date: Sep 2020 to Sep 2021
    • Eligibility criteria expanded, about 68 words
    • Secondary endpoint revised
    • Site contacts updated at 7 of 12 sites
    v9
  2. Study sites: 5 to 12v8
  3. Study sites: 4 to 5v7
  4. Enrollment target: 10 to 30
    • Primary completion date: Sep 30, 2019 to Sep 2020
    v6
  5. Primary endpoints: 2 to 1v5 Show 4 more changesShow less
    • Study sites: 2 to 4
    • Eligibility criteria shortened, about 17 words
    • Secondary endpoints expanded, about 9 words
    • Study title shortened, about 17 words
  6. Study sites: 1 to 2v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 17, 2017 to Dec 4, 2017
    • Study title shortened, about 1 word
    v3
  8. Start date: Jul 31, 2017 to Oct 17, 2017v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device. This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at the index procedure and at 30-day follow-up. The study will evaluate the delivery and deployment of the device, patency of branches and branch vessels, and exclusion of the aortic pathology. The data will help determine if modifications need to be made to the device, the procedural steps, operator technique, or the indications for use.
Trial Details
NCT Number NCT03214601
Lead Sponsor Bolton Medical
Conditions
(from sponsor)		 Thoracic Aorta Aneurysm, Aneurysm, Ruptured, Aortic Aneurysm
Related terms Aneurysm, Ruptured, Aortic Aneurysm, Aortic Aneurysm, Thoracic
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov