title: First-in-Man Experience With the ClearLumen Thrombectomy System as an Adjunctive Therapy in Primary Percutaneous Coronary Interventions.
abstract: OBJECTIVE
  To describe the first-in-man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI.
  
  
  BACKGROUND
  Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal.
  
  
  METHODS
  Prospective, single-centre, non-randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement of at least two of the following three criteria-TIMI flow 3 and/or myocardial blush grade ≥2 at completion of the case and ST-resolution >70% at 90 minutes after vessel reperfusion-was also evaluated.
  
  
  RESULTS
  Over a 3 months period 20 patients were enrolled in the study. Culprit lesion was successfully reached with the investigational device in 19 patients (95%). The pre-specified combined endpoint was met in 16 out of 19 patients (84.2%). Three patients not meeting the combined end point had procedure related, non TA associated, adverse event. Only 2 minor procedural adverse event occurred after thrombus aspiration.
  
  
  CONCLUSIONS
  This first-in-man experience with the ClearLumen Thrombectomy System demonstrates initial promising results on safety and efficacy when used as an adjunctive therapy during primary PCI.
authors.affiliation: The Heart Centre, Rigshospitalet, Copenhagen, Denmark.|Fondazione Cardiocentro Ticino, University of Zurich, Lugano, Switzerland.
authors.forename: Luigi
authors.initials: L
authors.lastname: Biasco
authors.affiliation: Department of Cardiology, Skåne University Hospital-Lund University, Lund, Sweden.
authors.forename: Matthias
authors.initials: M
authors.lastname: Götberg
authors.affiliation: Department of Cardiology, Skåne University Hospital-Lund University, Lund, Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Harnek
authors.affiliation: Department of Cardiology, Skåne University Hospital-Lund University, Lund, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Lundin
authors.affiliation: Piedmont Heart Institute, Atlanta, Georgia.
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.affiliation: The Heart Centre, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Ole
authors.initials: O
authors.lastname: De Backer
authors.affiliation: The Heart Centre, Rigshospitalet, Copenhagen, Denmark.|Department of Cardiology, Skåne University Hospital-Lund University, Lund, Sweden.
authors.forename: Göran K
authors.initials: GK
authors.lastname: Olivecrona
mesh_terms: D000368:Aged; D003131:Combined Modality Therapy; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D017131:Thrombectomy / Q000009:adverse effects / Q000295:instrumentation*; D016896:Treatment Outcome