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BIOTRONIK-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects With up to Two de Novo Coronary Artery Lesions - IV

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Trial Profile

BIOTRONIK-A Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Stent in the Treatment of Subjects With up to Two de Novo Coronary Artery Lesions - IV

Status: Active, no longer recruiting
Phase of Trial: Phase IV

Latest Information Update: 15 Sep 2023

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At a glance

  • Drugs Sirolimus (Primary) ; Everolimus
  • Indications Coronary artery disease; Coronary artery restenosis
  • Focus Therapeutic Use
  • Acronyms BIOFLOW-IV
  • Sponsors BIOTRONIK
  • Most Recent Events

    • 01 Sep 2023 Results of pooled analysis from BIOFLOW-II, -IV, and -V assessing the outcomes of patients with higher atherothrombotic risk (H-ATR) versus lower atherothrombotic risk (L-ATR) undergoing percutaneous coronary intervention (PCI) with either bioresorbable-polymer sirolimus-eluting stent (BP-SES) or durable-polymer everolimus-eluting stent (DP-EES published in the Clinical Research in Cardiology.
    • 01 Jul 2022 Results comparing the clinical outcomes after complex PCI with a bioresorbable-polymer sirolimus-eluting stent (BP-SES) versus a durable-polymer everolimus-eluting stent (NCT01356888, NCT01939249, NCT02389946) published in the Clinical Research in Cardiology
    • 01 Nov 2021 Results of pooled analysis (n=3717) assessing the safety and efficacy of a bioresorbable polymer sirolimus eluting stent system (BP-SES; Orsiro) compared to a durable polymer everolimus eluting stent system (DP-EES; Xience) in the pooled population as well as in subgroups from BIOFLOW-II (NCT01356888), -IV (NCT01939249), and -V (NCT02389946) as well as the all comers registry BIOFLOW-III (NCT01553526) studies, published in the Catheterization and Cardiovascular Interventions.
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