title: First clinical experience with the GARDEX EPD: a novel embolic protection device for carotid artery stenting.
abstract: OBJECTIVE
  Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy in the treatment of carotid artery disease. The use of an embolic protection device (EPD) can reduce the frequency of embolic events during CAS. Difficult vascular anatomy may complicate current generation EPD placement. This problem is addressed by a new EPD, the GARDEX System. The aim of this study was to assess the safety and performance of the GARDEX EPD during CAS.
  
  
  RESULTS
  Thirty-eight patients underwent CAS with the GARDEX EPD in two medical centres. All patients were prospectively followed up for 30 days. Device performance and procedural details were collected and analysed prospectively. Vessel anatomy and lesion morphology were evaluated and stratified into a scoring system for anatomic difficulty. More than a third of the patients were considered to have difficult vascular anatomy for CAS. All enrolled patients were successfully treated. There was one (2.6%) minor periprocedural stroke and there were two (5.3%) periprocedural TIAs which resolved within 24 hours. No additional complications were noted during the 30-day follow-up period.
  
  
  CONCLUSIONS
  In this first experience, CAS under cerebral protection with the GARDEX EPD was safe and feasible. Our data suggest that the use of the GARDEX EPD is simple and shows high success rates even in challenging anatomies. The role of this new device in CAS needs to be further confirmed in a larger patient population.
authors: Center for Vascular Medicine, Park Hospital Leipzig, Park Hospital Leipzig, Strümpellstrasse 41, Leipzig, Germany. office@drwerner.eu
authors: Martin
authors: M
authors: Werner
authors: Dierk
authors: D
authors: Scheinert
authors: Raffaello
authors: R
authors: Borghesi
authors: Alberto
authors: A
authors: Cremonesi
authors: Uri
authors: U
authors: Rosenschein
authors: Susanne
authors: S
authors: Scheinert
authors: Sven
authors: S
authors: Bräunlich
authors: Yvonne
authors: Y
authors: Bausback
authors: Matthias
authors: M
authors: Ulrich
authors: Andrej
authors: A
authors: Schmidt
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D017130:Angioplasty / Q000295:instrumentation* / Q000379:methods; D062906:Cardiac Catheters; D016893:Carotid Stenosis / Q000628:therapy*; D057505:Embolic Protection Devices; D004617:Embolism / Q000150:complications / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D020521:Stroke / Q000453:epidemiology / Q000517:prevention & control; D016896:Treatment Outcome