RecruitingNCT07166731

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

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


Sponsor

Acandis GmbH

Enrollment

536 participants

Start Date

Mar 1, 2026

Study Type

OBSERVATIONAL

Conditions

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 with high-risk plaque features for stroke recurrence compared to medical treatment alone with respect to the mid- and long-term clinical outcomes.


Eligibility

Min Age: 18 Years

Inclusion Criteria15

  • 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 Criteria19

  • 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

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Locations(1)

Städtisches Klinikum Solingen

Solingen, North Rhine-Westphalia, Germany

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NCT07166731


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