High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcandis GmbH

About this trial

Goal is to analyse the clinical safety and efficacy of the CARESTO® heal Stent within standard clinical routine for the treatment of patients with symptomatic non-stenotic carotid disease (SyNC) and with high-risk plaque features for stroke recurrence compared to medical treatment alone with respect to the mid- and long-term clinical outcomes.

Eligibility criteria

Qualifiers

Patients diagnosed with acute ischemic stroke or acute retinal artery ischemia within the last two weeks related to symptomatic non-stenotic carotid disease (SyNC) and high-risk carotid plaque features

Ipsilateral acute ischemic stroke must be determined by acute ischemic infarct on DWI or CT OR

by neurological symptoms indicating ipsilateral cortical deficits consistent with ischemia in the territory of the internal carotid artery and after exclusion of a significant microangiopathy

Acute retinal artery ischemia must be determined by ophthalmologic examination

Disqualifiers

Patients with acute complete occlusion of the carotid artery in an emergency setting

Incidence of acute infarcts in other vascular (i.e., not ipsilateral carotid) territories

Small vessel disease

Large vessel atherosclerotic disease ≥ 50%

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

536 Participants
are grouped into 2 trial groups

Sponsors and collaborators