TARGET FIRST is a prospective, international, multicentre, open-label, randomized (1:1) post-market study to evaluate the impact of Firehawk stent, a drug eluting stent (DES) with high biocompatibility feature, associated with a complete revascularization when needed and short post-procedural Dual Antiplatelet Therapy (DAPT) (consisting of a reduced duration of DAPT followed by P2Y12 inhibitor monotherapy up to 12 months), in reaching non-inferior Net Adverse Clinical and Cerebral Events (NACCE) among clinically stable, low to moderate complexity acute Myocardial Infarction (MI) patients. The secondary objective is to evaluate the impact of Firehawk stent, associated with a complete revascularization when needed and a short post-procedural DAPT, in reducing bleeding events among clinically stable, low to moderate complexity acute MI patients.
Net Adverse Clinical and Cerebral Events (NACCE) defined as a composite of all cause death, non-fatal myocardial infarction, definite/probable stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding at 11 months post randomization (12 months post index procedure).
- Site qualification
- Regulatory Submissions (except in France)
- Project Management
- Data Management
- Contracts Management (except in France)
- SAE Reporting
8 (Austria, Belgium, France, Italy, The Netherlands, Portugal, Spain, Switzerland)
Approximately 50 sites