DIRECTOR Study Design

Title: DIRECT Stenting Study with the OrbusNeich R stent .
Objective: To demonstrate clinical safety and efficacy with the R stent using a direct stenting strategy.
Clinics: Multi-center prospective registry of 20 international sites.
Design: Controlled, multi-center, prospective registry using the OrbusNeich R stent on the EVOLUTION Delivery System.
Size: A total of 128 patients were included.
Patient Population: Patients with stenotic lesions in native coronary arteries that can be treated with a single 18 mm R stent and with objective evidence of ischemia.
Treatment Direct stenting using a single 18 mm R stent with diameters from 3.0 to 4.0 mm.
Primary Endpoint: Procedural success at one month [DS < 30% post procedure without major adverse cardiac and cerebrial events (MACCE)].
Secondary Endpoints:
  1. Clinical success:
    MACCE and anginal status at six and nine months.
    Justified and non-justified revascularization.

  2. Safety parameters:
    Major bleeding and major vascular complications at 30 days.

  3. Angiographic results (by independent core lab):
    Optimal and suboptimal stent result.
    In- stent and vessel segment diameter stenosis (DS) post-procedure.
    In- stent and vessel segment DS, minimum lumen diameter (MLD), and restenosis rate at six months.
Sponsor: OrbusNeich
CRO: Cardialysis B.V. Rotterdam, The Netherlands
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