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.
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).
Sugita
Jennifer
J
Cardiovascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany.
Cremonesi
Alberto
A
Van Elst
Francis
F
Stockx
Luc
L
Mathias
Klaus
K
Schofer
Joachim
J
Suttorp
Maarten-Jan
MJ
Reul
J
J
Lowens
Stephan
S
Sievert
Horst
H
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