CaRESS: carotid revascularization using endarterectomy or stenting systems.
The primary objective of the CaRESS Phase I trial is to determine the sample size needed to reliably test the hypothesis that carotid stenting systems with distal embolic protection (CAS) is equivalent to carotid endarterectomy (CEA) in the treatment of symptomatic and asymptomatic carotid artery disease in a broad-risk population. A total of 397 patients were treated at 14 clinical centers. The primary endpoint results of combined all-cause mortality and stroke at 30-days and 1-year are presented. The CaRESS Phase I study was able to closely resemble clinical practice and results suggest equivalence between treatment groups.
Diethrich
Edward
E
Arizona Heart Institute, Pheonix, USA.
Fogarty
Thomas J
TJ
Zarins
Christopher K
CK
Hopkins
L Nick
LN
Roubin
Gary S
GS
Wholey
Mark H
MH
Nimsky
Shirley
S
McKinlay
Sonja
S
Siami
Flora Sandra
FS
D000800:Angioplasty, Balloon; D016893:Carotid Stenosis / Q000628:therapy*; D017321:Clinical Trials, Phase I as Topic; D004617:Embolism / Q000517:prevention & control; D016894:Endarterectomy, Carotid; D006801:Humans; D015337:Multicenter Studies as Topic; D015607:Stents