title: First clinical experiences with an endovascular clamping system for neuroprotection during carotid stenting.
abstract: OBJECTIVE
  This report evaluates the feasibility and efficacy of an endovascular blood flow blockage technique to prevent intracerebral embolization of plaque debris during carotid artery stenting.
  
  
  METHODS
  Forty-two patients were enrolled in five clinical sites in Germany and Italy with either an asymptomatic internal carotid artery stenosis > or =75% (mean 87%) or a symptomatic stenosis > or =60% (mean 85%). Cerebral protection during the stenting procedure was achieved using an endovascular clamping technique, obtained by occlusion of the external and common carotid artery via two independently inflatable balloons integrated in the Mo.Ma system. Blood with particulate plaque debris was aspirated before flow was restored. The patient's clinical and the neurological status were assessed during intervention, at discharge, and at 3 months follow-up.
  
  
  RESULTS
  Stenting was performed in all but one patient. The mean flow occlusion time was 10.6+/-6.5 min. Transient clamping intolerance was observed in five patients (12%). In two patients, neurological deficits persisted for 2 and 12 h, respectively. Two minor strokes (4,7%) occurred at 5 and 72 h after the procedure. No major strokes or deaths were observed at 3 months follow-up.
  
  
  CONCLUSIONS
  This first clinical experience with the Mo.Ma device substantiates the feasibility of endovascular clamping in preventing cerebral embolization during carotid artery stenting.
authors.affiliation: University of Leipzig, Heart Center, Leipzig, Germany. d.diederich@medizin.uni-leipzig.de
authors.forename: K-W
authors.initials: KW
authors.lastname: Diederich
authors.forename: D
authors.initials: D
authors.lastname: Scheinert
authors.forename: A
authors.initials: A
authors.lastname: Schmidt
authors.forename: S
authors.initials: S
authors.lastname: Scheinert
authors.forename: B
authors.initials: B
authors.lastname: Reimers
authors.forename: H
authors.initials: H
authors.lastname: Sievert
authors.forename: K
authors.initials: K
authors.lastname: Rabe
authors.forename: G
authors.initials: G
authors.lastname: Coppi
authors.forename: R
authors.initials: R
authors.lastname: Moratto
authors.forename: F-J
authors.initials: FJ
authors.lastname: Hoffmann
authors.forename: G C
authors.initials: GC
authors.lastname: Schuler
authors.forename: G
authors.initials: G
authors.lastname: Biamino
mesh_terms: D002343:Carotid Artery, Internal / Q000000981:diagnostic imaging; D016893:Carotid Stenosis / Q000628:therapy*; D002404:Catheterization / Q000009:adverse effects; D003250:Constriction; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D020766:Intracranial Embolism / Q000517:prevention & control; D008297:Male; D011859:Radiography; D015607:Stents; D020521:Stroke / Q000517:prevention & control