title: A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet).
abstract: OBJECTIVE
  This study sought to evaluate the feasibility of the CGuard Carotid Embolic Protective Stent system-a novel thin strut nitinol stent combined with a polyethylene terephthalate mesh covering designed to prevent embolic events from the target lesion in the treatment of carotid artery lesions in consecutive patients suitable for carotid artery stenting.
  
  
  BACKGROUND
  The risk of cerebral embolization persists throughout the carotid artery stenting procedure and remains during the stent healing period.
  
  
  METHODS
  A total of 30 consecutive patients (age 71.6 ± 7.6 years, 63% male) meeting the conventional carotid artery stenting inclusion criteria were enrolled in 4 centers in Germany and Poland.
  
  
  RESULTS
  The primary combined endpoint was the procedure success of the CGuard system and the number and volume of new lesions on the ipsilateral side assessed by diffusion-weighted magnetic resonance imaging at 48 h post-procedure and at 30 days. The secondary endpoint was 30-day major adverse cardiac or cerebrovascular events (death, stroke, or myocardial infarction). Protection devices were used in all procedures. Procedure success was 100%, with 0% procedural complications. The 30-day major adverse cardiac or cerebrovascular events rate was 0%. New ipsilateral ischemic lesions at 48 h occurred in 37.0% of patients and the average lesion volume was 0.039 ± 0.08 cm(3). The 30-day diffusion-weighted magnetic resonance imaging showed complete resolution of all but 1 periprocedural lesion and only 1 new minor (0.116 cm(3)) lesion in relation to the 48-h scan.
  
  
  CONCLUSIONS
  The use of the CGuard system in patients undergoing carotid artery stenting is feasible. In addition, the benefit of using CGuard may extend throughout the stent healing period.
authors: Medical Care Center, Hamburg University Cardiovascular Center, Hamburg, Germany. Electronic address: Schofer@herz-hh.de.
authors: Joachim
authors: J
authors: Schofer
authors: Jagiellonian University Department of Cardiac and Vascular Diseases, John Paul II Hospital, Krakow, Poland.
authors: Piotr
authors: P
authors: Musiałek
authors: Medical Care Center, Hamburg University Cardiovascular Center, Hamburg, Germany.
authors: Klaudija
authors: K
authors: Bijuklic
authors: Augusta Hospital, Dusseldorf, Germany.
authors: Ralf
authors: R
authors: Kolvenbach
authors: Jagiellonian University Department of Cardiac and Vascular Diseases, John Paul II Hospital, Krakow, Poland.
authors: Mariusz
authors: M
authors: Trystula
authors: Jagiellonian University Department of Cardiac and Vascular Diseases, John Paul II Hospital, Krakow, Poland; Krakow Cardiovascular Research Institute, Krakow, Poland.
authors: Zbigniew
authors: Z
authors: Siudak
authors: CardioVascular Center, Frankfurt, Germany.
authors: Horst
authors: H
authors: Sievert
mesh_terms: D000368:Aged; D000497:Alloys; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation*; D002340:Carotid Artery Diseases / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D038524:Diffusion Magnetic Resonance Imaging; D057505:Embolic Protection Devices; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D006801:Humans; D020766:Intracranial Embolism / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011044:Poland; D011093:Polyethylene Terephthalates; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D015607:Stents; D020521:Stroke / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D013526:Surgical Mesh; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000497:Alloys; D011093:Polyethylene Terephthalates; C013616:nitinol
keywords: carotid artery stenting; diffusion-weighted magnetic resonance imaging; embolic protection; mesh stent