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A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions - The BIFSORB Pilot Study II (NCT03027856)

The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.
  • Device: Magmaris
    Implantation of a sirolimus eluting bioresorbable magnesium stent
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Stable angina pectoris
    • Stabilized non-ST elevation myocardial infarction
    • Silent angina pectoris
    • Age > 18 years
    • De novo coronary bifurcation lesion at LAD/diagonal, CX/obtuse marginal or RCA-PDA/posterolateral branch
    • All Medina classes except Medina x.x.1.
    • Diameter of side branch ≥ 2.5 mm
    • Side branch diameter stenosis less than 50%
    • Signed informed consent
    Exclusion Criteria:
    • ST-elevation infarction within 48 hours
    • Expected survival < 1 year
    • Severe heart failure (NYHA≥III)
    • S-creatinine > 120 µmol/L or GFR < 0.45 mL/min per 1.73 m2
    • Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine or sirolimus
    • Unable to cover main vessel lesion with one stent
    • Severe tortuosity
    • Severe calcification
    Bioresorbable stents are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time.

    The aim of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.

    Hypothesis: treatment of coronary bifurcation lesions using the Magmaris BRS is safe and feasible.

    Methods:

    The study is a proof-of-concept, prospective, single arm study with inclusion of 20 patients. Planned 1-and 12-month follow-up by optical coherence tomography (OCT) and follow-up for clinical endpoints until 5 years.

    Written informed consent is required before the procedure is performed. Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the stent.

    At baseline, the target lesion is assessed by OCT before, during and after implantation of the Magmaris BRS. OCT assessment is performed again at 1- and 12-month follow-up, or before if the patient is readmitted with a possible target lesion failure.

    The operator is not blinded to the OCT images as pre-PCI images should be used for sizing and positioning of the stent, and procedural OCT images are used to optimize stent implantation before performing final OCT.

    1 locations

    Denmark (1)
    • Aarhus University Hospital
      recruiting
      Aarhus N, Denmark, 8000
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    31 August, 2016
    Updated:
    16 August, 2017
    Participants:
    20
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