High-coverage carotid stent versus medical treatment to prevent embolism from symptomatic non-stenotic carotid disease (SyNC)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, randomized, parallel-group, open-label study with blinded safety endpoints compares the CARESTO® heal stent plus routine care to medical management alone in patients with symptomatic non‑stenotic carotid disease (<50% narrowing) and high‑risk plaque features. Eligible participants have had an ipsilateral ischemic stroke or retinal ischemia within the prior two weeks and no other identifiable embolic source. Patients are randomly assigned to carotid stenting or to contemporary medical therapy and followed for mid- and long-term clinical and safety outcomes, including recurrent embolic events. The aim is to produce unbiased data to clarify the optimal treatment approach for vulnerable low‑grade carotid plaques.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Städtisches Klinikum Solingen
  Solingen, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Study coordinator: Acandis GmbH
• Email: info@acandis.com
• Phone: +49 (0) 7231 - 155 00 171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.