Stent-protected angioplasty in asymptomatic carotid artery stenosis: SPACE-2

• Applicant: Professor Dr. Werner Hacke
• Subject Area: Clinical Neurology; Neurosurgery and Neuroradiology
• Term: from 2008 to 2019
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 44273906

Patients with asymptomatic carotid stenosis have an increased stroke risk and are at also higher risk of non-stroke vascular events. Treatment of individuals with asymptomatic carotid artery stenosis is handled controversially. The advantage of carotid endarterectomy (CEA) compared to conservative treatment in asymptomatic patients is less well established because of improved medical treatment options. Carotid artery stenting (CAS) has been developed as an alternative to CEA and is done frequently, although superiority or noninferiority of CAS has not been demonstrated. SPACE-2 is planned to close this lack of knowledge. The study is a randomized, controlled three-arm trial with approximately 3,640 patients to be enrolled. On the first level, a superiority trial of intervention (CAS or CEA) versus state of the art conservative treatment is designed. In case of superiority of the interventions, a non-inferiority endpoint will be tested between CAS and CEA. The study will be performed in about 100 study centers Germany, Austria and Switzerland. The study will have a Steering Committee, a DSMB, an endpoint Adjudication Committee and an independent monitoring. The core group of investigators has also performed the successful SPACE trial, in which 1,200 patients where randomized with symptomatic disease, a condition that is less frequent than asymptomatic disease. Therefore, we believe that it will be possible to randomize more than 3.500 patients in three years.

• DFG Programme: Clinical Trials
• Participating Persons: Professor Dr. Hans-Henning Eckstein; Professor Dr. Olav Jansen