Objective The trial was designed to evaluate the safety and performance of the ev3 Protégé TM stent in the treatment of de novo or re-stenotic common and/or internal carotid artery stenoses with adjunctive u...Objective The trial was designed to evaluate the safety and performance of the ev3 Protégé TM stent in the treatment of de novo or re-stenotic common and/or internal carotid artery stenoses with adjunctive use of a CE-marked filter embolic protection device.Methods This study was a prospective multi-center, single-arm trial. Between June and October 2003, 77 patients were enrolled in 8 investigational centers throughout Europe. The primary endpoint was the incidence of Major Neurological Events (MANE) through one month. Other endpoints were the ability to properly place the stent, and primary patency and MANE after six months. Eligible for the study were patients with a de novo or restenotic target lesion located in the common and/or internal carotid artery (>70% stenosis for asymptomatic and >50% stenosis for symptomatic patients). The ev3 Spider (Embolic Protection Filter was used in 75 of 77 cases. Results In 76 out of the 77 patients (99%), the stent could be successfully implanted with a residual stenosis ≤30% as criterion. Of the 74 patients that had a carotid ultrasound at one month follow-up, none had a re-stenosis of the target lesion. There were three MANEs during or immediately after the procedure (3.9%), two were major and one was a minor stroke. There were eight severe complications (9.1%); six of these happened during or immediately after the procedure and were related to the procedure, none was related to the device. They are resolved without sequelae. No deaths have occurred.Conclusions The Protégé stent is safe and performs well in the treatment of carotid artery stenosis. The technical success rate for placement of the Protégé stent as assessed by the residual stenosis post implant was very high and all stents were successfully deployed. The incidence of MANE was comparable with that in other recent carotid stent studies and still lower than standard CEA.展开更多
文摘Objective The trial was designed to evaluate the safety and performance of the ev3 Protégé TM stent in the treatment of de novo or re-stenotic common and/or internal carotid artery stenoses with adjunctive use of a CE-marked filter embolic protection device.Methods This study was a prospective multi-center, single-arm trial. Between June and October 2003, 77 patients were enrolled in 8 investigational centers throughout Europe. The primary endpoint was the incidence of Major Neurological Events (MANE) through one month. Other endpoints were the ability to properly place the stent, and primary patency and MANE after six months. Eligible for the study were patients with a de novo or restenotic target lesion located in the common and/or internal carotid artery (>70% stenosis for asymptomatic and >50% stenosis for symptomatic patients). The ev3 Spider (Embolic Protection Filter was used in 75 of 77 cases. Results In 76 out of the 77 patients (99%), the stent could be successfully implanted with a residual stenosis ≤30% as criterion. Of the 74 patients that had a carotid ultrasound at one month follow-up, none had a re-stenosis of the target lesion. There were three MANEs during or immediately after the procedure (3.9%), two were major and one was a minor stroke. There were eight severe complications (9.1%); six of these happened during or immediately after the procedure and were related to the procedure, none was related to the device. They are resolved without sequelae. No deaths have occurred.Conclusions The Protégé stent is safe and performs well in the treatment of carotid artery stenosis. The technical success rate for placement of the Protégé stent as assessed by the residual stenosis post implant was very high and all stents were successfully deployed. The incidence of MANE was comparable with that in other recent carotid stent studies and still lower than standard CEA.
