Status:
NOT_YET_RECRUITING
High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)
Lead Sponsor:
Acandis GmbH
Conditions:
Carotid Artery Disease
Symptomatic Carotid Artery Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
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 w...
Detailed Description
The purpose of the CARESTAR study 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...
Eligibility Criteria
Inclusion
- 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
- Patients with no other identifiable cause of stroke, evaluated using standard echocardiographic examinations to exclude cardiogenic or aortogenic sources of embolism
- Symptomatic non-stenotic carotid disease defined as one or more plaques in the ipsilateral internal carotid artery causing 10-49% luminal narrowing AND
- Presence of high-risk plaque features which must be determined through visual inspection on CTA or MRI (Ultrasound findings alone are insufficient; features must be confirmed by CTA or MRI to meet the criteria):
- Identification of at least two of the following characteristics Plaque thickness ≥ 3mm Irregular plaque surface Ulceration \<50% plaque calcification Lipid-rich necrotic core
- and/or identification of at least one of the following characteristics Intraplaque haemorrhage
- Presence of carotid web characterized as shelf-like/linear, smooth filling defects
- Plaque assessment including evaluation of the presence of high-risk features by routine imaging (CTA, MRI) confirmed by an independent CoreLab
- Signed Informed Consent Form
- Patient ≥ 18 years
- mRS ≤ 3 at time of randomisation
- Dual antiplatelet therapy (DAPT) according to standard of care before endovascular treatment
Exclusion
- 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
- Patients in whom the stroke was likely caused by one of the following diseases:
- Small vessel disease
- Large vessel atherosclerotic disease ≥ 50%
- Cardioembolism
- Other known disease e.g. vasculitis
- Predominantly calcified Plaques (≥50% calcified plaque components on CT-Angio)
- Patients presenting with intraluminal carotid thrombus (e.g. characterized by 'donut sign' on CTA)
- Patients with highly tortuous vessels (\>90°) which may prevent access or safe insertion of the stent
- Patients with post-CEA re-stenosis or post-CAS re-stenosis
- Patients with blood coagulation disorders
- Patients in whom access to the carotid lesion is impossible or associated with an increased risk of procedural complications
- Patients with lesions in the ostium of the common carotid artery
- Patients with known hypersensitivity to nickel-titanium
- Patients who are allergic to heparin
- Any known conditions that affect life expectancy to less than 12 months
- Any known conditions associated with an increased risk of endovascular treatment
- Patients not able to visit the outpatient clinic for annual follow-up
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2032
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT07166731
Start Date
November 1 2025
End Date
January 1 2032
Last Update
September 17 2025
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