Registry of Patients With a Bioabsorbable Magnesium Stent Implant MAGMARIS in Usual Clinical Practice
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational [Patient Registry]

Summary: 
      The safety and efficacy of percutaneous coronary revascularization has been progressively
      increasing since its inception, and the problem of restenosis has been minimized.

      The efficacy and safety data of the Magmaris stent are quite high, in selected cases.

      The objective is to evaluate the efficacy and safety of the bioabsorbable stent MAGMARIS in
      the percutaneous treatment of severe coronary disease (in vessels between 2.7mm and 3.75 mm)
      in routine clinical practice in poorly selected populations.
    

Detailed description: 
      This is a multicentre, observational, prospective registry of patients without a control
      group designed to evaluate the efficacy and safety of the bioabsorbable coronary device,
      according to the indications for use, in routine clinical practice in a consecutive number of
      patients undergoing percutaneous coronary intervention (PCI) in de novo coronary arteries
      lesions in a native coronary artery.

      After the implantation of the device, a telephone or face-to-face follow-up will be carried
      out in the first month, at 12 months and at 24 months.

      A total of 445 patients are expected to be included in the registry. Patients, will be
      included consecutively in each center over a year. A selection period of 23 months or until
      the estimated sample size has been planned, with a follow-up of two years. Subsequently, it
      will take at least 3 months for data analysis, another 2 months for the final report and at
      least 3 more months for the publication of the results for publication. This implies that the
      total duration of the study will be 55 months counted from the inclusion of the first
      patient.

      The procedure will be carried out according to the usual practice of each center, paying
      special attention to the correct expansion of the scaffold, postdilating with non-compliant
      balloons when necessary.

      The collection of information from the study will be carried out on a data collection
      template in electronic format, which will include clinical, anatomical, procedural and
      follow-up data; in baseline circumstances, during hospitalization, after discharge and
      throughout follow-up at 1, 12, and 24 months. The source documents will be the patient's
      medical records collected at the center.

      The monitoring will be done monthly and online. Two face-to-face monitoring will be done to
      20% of the patients, during the inclusion and follow-up phases. Afterwards, a face-to-face
      monitoring will be carried out for the closing visit.

      Descriptive and univariate statistics will be performed. The primary variable is the MACE
      rate at 12 months, composed of cardiac death, myocardial infarction and TLR induced by
      ischemia (primary objectives). The secondary variables will be combined indices of events
      both in the hospital phase, and after discharge in the follow-up at 1, 12 and 24 months.

      A final report will be prepared containing all the results of the study, in a period of 6
      months once the same one finalized. The participating researchers and the Ethical Committees
      of the hospitals will be informed about this.
    

Intervention name(s): Magmaris
Intervention type(s): Device
Intervention description(s): Severe stenosis de novo, in native coronary arteries, treated with percutaneous coronary intervention with scaffold implantation.
Other intervention name(s): Bioresorbable scaffold
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with ischemic heart disease by de novo lesions in native coronary arteries,
        candidates for revascularization with coronary stent.
      
Keywords: Magmaris