RESTOR Study Design

Title: RESTOR, R stent Efficacy and Safety Trial ORbusNeich.
Objective: To demonstrate efficacy and safety of the OrbusNeich R stent in patients with single de novo lesions in native coronary arteries.
Clinics: Amphia Hospital, Breda. The Heart Center, Rotterdam.
Design: Multicenter, prospective registry.
Size: A total of 121 patients were included.
Patient Population: Patients with a single de novo lesion (max. 25 mm in length) in a native coronary artery with objective evidence of ischemia.
Treatment: PCI using a single R stent placement with lengths 9, 13, 18, 23 or 28 mm and diameters between 2.5 and 4.0 mm.
Primary Endpoint: Major adverse cardiac events (MACE) at six months. MACE includes cardiac death, myocardial infarction (MI), coronary artery bypass graft (CABG) and target lesion revascularization (TLR)..
Secondary Endpoints:
  1. Angiographic success:
    Percentage diameter stenosis (DS), minimum lumen diameter (MLD), and restenosis rate at six months by independent core lab.
  2. Clinical parameters:
    MACE at one and six months.
  3. Safety parameters:
    Major bleeding and major vascular complications at 30 days.
Sponsor: OrbusNeich
CRO: Cardialysis B.V. Rotterdam, The Netherlands