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

NCT07166731 | Recruiting DMC

• 1 other identifier: CARESTAR Study
• Study Type: observational
• Target: 536
• Locations: 1 country
• Sites: 1

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

Conditions

Carotid Artery Disease; Symptomatic Carotid Artery Stenosis; Carotid Artery Stenting; Carotid Plaque Imaging; Embolic Stroke of Undetermined Source; Carotid Artery Thrombosis

Keywords

SyNC; Carotid artery disease; carotid artery stenting; symptomatic non-stenotic carotid artery disease; carotid artery stenosis; symptomatic carotid artery stenosis

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint as rate of events of ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia analysed as time to first occurence

  Ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia during follow-up analysed as time to first occurence

  Through study completion, an average of 54 months

Secondary Outcomes (2)

• Secondary Endpoint of Incidence of events and change from functional status

  Through study completion, an average of 54 months

• Secondary Endpoint of Incidence of events and change from functional status

  Through study completion, an average of 54 months

Other Outcomes (3)

• Safety Endpoint as rate of symptomatic stroke, death, or myocardial infarktion as safety endpoint

  30 ± 10 days after randomisation

• Treatment Endpoints as rate of (Peri-)procedural complications

  Periprocedural

• Exploratory outcomes as rate of morphological changes

  Through study completion, an average of 54 months

Study Arms (2)

Endovascular Treatment Group

This group will be both given medical treatment according to standard clinical routine and treated by carotid artery stenting with the high coverage carotid stent (CARESTO® heal, Acandis® Pforzheim)

Best medical treatment group

This group will be given medical treatment according to standard clinical routine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with \<50% symptomatic non-stenotic carotid disease (SyNC) who were treated after randomisation by: Endovascular Treatment Group: Stenting + medical management o This group will be both given medical treatment according to standard clinical routine and treated by carotid artery stenting with the high coverage carotid stent (CARESTO® heal, Acandis® Pforzheim) Best medical treatment group: Medical management alone o This group will be given medical treatment according to standard clinical routine

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acandis GmbH: lead

Study Sites (1)

Städtisches Klinikum Solingen

Solingen, North Rhine-Westphalia, 42653, Germany

RECRUITING

Related Links

• Complicated Carotid Artery Plaques as a Cause of Cryptogenic Stroke

MeSH Terms

Conditions

Carotid Artery Diseases; Carotid Artery Thrombosis; Carotid Stenosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Embolism and Thrombosis; Thromboembolism; Embolism and Thrombosis; Arterial Occlusive Diseases

Central Study Contacts

Acandis GmbH

CONTACT

+49 (0) 7231 - 155 00 171; info@acandis.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 10, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 31, 2032
• Study Completion (Estimated): June 1, 2032
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

DE (1)