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Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease

Study acronym: SIRONA
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 26 to 22v12
  2. Re-verified, no change to tracked fieldsv11
  3. Study sites revised (26)
    • Collaborators: 4 to 3
    • Publications: details revised at 1 of 2 entries
    v10
  4. Primary completion date: Dec 31, 2027 to Dec 31, 2023
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 28 to 26
    • Study completion date: May 31, 2028 to Dec 31, 2027
    v9
  5. Site details revised at 2 of 28 sitesv8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 27 to 28
    • Eligibility criteria revised
    v7
  2. Eligibility criteria expanded, about 95 words
    • Study sites revised (27)
    • Collaborators revised (4)
    v6
  3. Start date: Mar 13, 2021 to Apr 13, 2021v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 15, 2021 to Mar 13, 2021
    • Site details revised at 27 of 27 sites
    v4
  5. Start date: Jan 1, 2021 to Feb 15, 2021v3
  6. Start date: Oct 1, 2020 to Jan 1, 2021v2 Show 4 more changesShow less
    • Study sites: 3 to 27
    • Primary completion date: Oct 31, 2027 to Dec 31, 2027
    • Secondary endpoints: details revised at 2 of 10 entries
    • Study title expanded, about 6 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with PTX drug-coated balloon (control device) in patients with femoropopliteal artery disease.
Trial Details
NCT Number NCT04475783
Lead Sponsor Jena University Hospital
Collaborators: Concept Medical Inc., Vascuscience, CoreLab Black Forest
Conditions
(from sponsor)		 Peripheral Artery Disease
Related terms Peripheral Arterial Disease
Enrollment 478 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov