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Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System

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

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 1859 to confirmed 1861 · Site details revisedv7 Show 2 more changesShow less
    • Enrollment target: estimated 1859 to confirmed 1861
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of May 2024 to May 13, 2024 · Interventions: DREAMS 3G RMS (Device), Xience DES (Device) to Freesolve RMS (Device), Xience DES (Device) · 2 morev6 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2024 to May 13, 2024
    • Interventions: DREAMS 3G RMS (Device), Xience DES (Device) to Freesolve RMS (Device), Xience DES (Device)
    • Study description shortened, about 2 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jan 2027 to Feb 2027 Completion date: Jan 2032 to Feb 2032 · Start date: Apr 2024 to May 2024 · Eligibility criteria shortened, about 1 wordv5 Show 3 more changesShow less
    • Completion date: Jan 2032 to Feb 2032
    • Start date: Apr 2024 to May 2024
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria expanded, about 45 wordsv4 See this version in full on ClinicalTrials.gov ↗
  5. Lead sponsor: Biotronik, Inc. to Biotronik AG Primary completion date: Mar 2026 to Jan 2027 · Start date: Jun 2023 to Apr 2024 · Enrollment target: 1728 to 1859 · 4 morev3 Show 7 more changesShow less
    • Primary completion date: Mar 2026 to Jan 2027
    • Start date: Jun 2023 to Apr 2024
    • Enrollment target: 1728 to 1859
    • Completion date: Mar 2030 to Jan 2032
    • Eligibility criteria shortened, about 19 words
    • Study description shortened, about 1 word
    • Collaborators shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  6. Collaborators: 2 to 1v2 See this version in full on ClinicalTrials.gov ↗
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of this study is to assess the safety and efficacy of the Freesolve in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).
Trial Details
NCT Number NCT05540223
Lead Sponsor Biotronik AG
Conditions Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease, Acute Coronary Syndrome, Angina Pectoris
Enrollment 1,861 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov