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The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis Study

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Mar 2024 to Oct 18, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 29 of 29 sites
    v18
  2. Study sites: 27 to 29v17
  3. Study sites: 24 to 27v16
  4. Site details revised at 6 of 24 sitesv15
  5. Primary completion date: May 2022 to Mar 2024
    • Study completion date: Sep 2022 to Mar 2028
    v14
Show 12 earlier versionsHide 12 earlier versions
  1. Site details revised at 9 of 24 sitesv13
  2. Site details revised at 8 of 24 sitesv12
  3. Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 2 of 24 sites
    v11
  4. Study sites: 16 to 24v10
  5. Site details revised at 1 of 16 sitesv9
  6. Site details revised at 2 of 16 sitesv8
  7. Study sites: 18 to 16v7
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2021 to Aug 27, 2021
    • Site details revised at 18 of 18 sites
    v6
  9. Start date: Jul 2021 to Sep 2021
    • Study completion date: Jun 2022 to Sep 2022
    v5
  10. Lead sponsor: [Redacted] to Hancock Jaffe Laboratiores, Incv4 Show 6 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: May 2022
    • Study completion date: Jun 2022
    • Start date: Jul 2021
    • Collaborators expanded, about 5 words
    • Study title shortened, about 4 words
  11. 2 versions Re-verified since Jun 28, 2021, no change to tracked fieldsv2-v3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A prospective, non blinded, single arm, multicenter study designed to assess the safety and effectiveness of the bioprosthetic, VenoValve, which is surgically implanted into the deep venous system for treatment of patients with deep venous valvular insufficiency ( C4b-C6 patients).
Trial Details
NCT Number NCT04943172
Lead Sponsor Hancock Jaffe Laboratiores, Inc
Collaborators: AXIOM Real Time Metrics, Syntactx
Conditions
(from sponsor)		 Deep Venous Insufficiency (Diagnosis)
Related terms Disease
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov