title: European carotid PROCAR Trial: prospective multicenter trial to evaluate the safety and performance of the ev3 Protégé stent in the treatment of carotid artery stenosis--1- and 6-month follow-up.
abstract: BACKGROUND
  The purpose of the European PROCAR Trial was to evaluate the safety and performance of the Protégé stent in the treatment of common and/or internal carotid artery stenoses with adjunctive use of a filter embolic protection device.
  
  
  METHODS
  The Protégé GPS stent is a self-expanding Nitinol stent system mounted on a 6 Fr 0.018'' (6-9 mm stent) or 7 Fr 0.035'' (10 mm stent) over-the-wire delivery system. Study patient assessments were conducted at baseline, periprocedure, discharge, and 1 and 6 months postprocedure. A total of 77 patients have been enrolled in the trial.
  
  
  RESULTS
  In the 77 lesions treated (31 symptomatic, 46 asymptomatic), the procedure was technically successful in 76 (99%), with an average residual stenosis of less than 30%. One procedure failed because the embolic protection device could not be retrieved and the patient was sent to surgery. Within 30 days, there were four (5.2%) major adverse neurological events (MANEs). Three of the MANEs were major strokes (3.9%), one a minor stroke. The fifth MANE occurred prior to the 6-month follow-up visit; this patient had a major stroke 75 days after the procedure and died 36 days later. One additional death occurred because of urosepsis.
  
  
  CONCLUSIONS
  The PROCAR trial shows that the Protégé stent with adjuvant use of a filter embolic protection device satisfies safety and performance criteria for the treatment of carotid artery stenosis. The incidence of MANEs for the Protégé stent is comparable to the incidence of these events in other recent carotid stent studies and standard carotid endarterectomy (CEA).
authors.affiliation: Cardiovascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Sugita
authors.forename: Alberto
authors.initials: A
authors.lastname: Cremonesi
authors.forename: Francis
authors.initials: F
authors.lastname: Van Elst
authors.forename: Luc
authors.initials: L
authors.lastname: Stockx
authors.forename: Klaus
authors.initials: K
authors.lastname: Mathias
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.forename: Maarten-Jan
authors.initials: MJ
authors.lastname: Suttorp
authors.forename: J
authors.initials: J
authors.lastname: Reul
authors.forename: Stephan
authors.initials: S
authors.lastname: Lowens
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon; D019917:Blood Vessel Prosthesis Implantation; D016893:Carotid Stenosis / Q000503:physiopathology / Q000628:therapy*; D005060:Europe; D005260:Female; D005263:Femoral Artery; D006440:Hemofiltration / Q000295:instrumentation; D006801:Humans; D015994:Incidence; D008297:Male; D011446:Prospective Studies; D018570:Risk Assessment; D015607:Stents / Q000009:adverse effects*; D016896:Treatment Outcome; D014654:Vascular Patency