An observational study in Carotid Artery Disease, Symptomatic Carotid Artery Stenosis and Carotid Artery Stenting, sponsored by Acandis GmbH. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Acandis GmbH · Observational
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.
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 carotid disease (SyNC) \<50% and with high-risk plaque features for stroke recurrence compared to the medical treatment group and with respect to the mid- and long-term clinical outcomes. By randomly assigning participants to the two treatment arms, the aim is to generate bias-free and reliable data that can provide information on the optimal treatment approach in this patient group. Despite advances in medical therapy and endovascular treatment, the optimal treatment strategy for low-grade vulnerable plaques remains unclear. There is therefore an urgent need to evaluate the efficacy and safety of minimally invasive procedures such as carotid stenting against medical treatment according to clinical routine in this specific patient group. With CARESTAR, a multicentre, prospective, randomised, parallel-grouped open label and blinded safety endpoint study this gap shall be closed. Given the considerations outlined above, symptomatic non-stenotic carotid disease (SyNC) \<50% with neurological symptoms represents a desperate situation, where all available options for contribution to the improvement of the patient's state of health or to the prevention of secondary diseases should be considered.
248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.
This study's planned enrollment of 536 is above the median of 224 across 108 observational studies indexed under Carotid Artery Diseases.
Browse Carotid Artery Diseases studies →Acandis GmbH is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
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
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):
Exclusion Criteria:
Small vessel disease
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)
This group will be given medical treatment according to standard clinical routine
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
Time frame: Through study completion, an average of 54 months
Secondary Endpoint of Incidence of events and change from functional status
* Each of the components of the primary outcome: Rate of Ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia * A composite of rate of ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia during follow-up or any symptomatic stroke, death, or myocardial infarction within 30 ± 10 days after randomisation * A composite of rate of disabling ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia during follow-up or disabling stroke, death, or disabling myocardial infarction within 30 ± 10 days after randomisation, where disabling is defined as any event resulting in a worsening by at least one point on the modified Rankin Scale (mRS) (e.g. 0-6) * Rate of any change in functional status from admission to follow-up visits, assessed using the Canadian Outcome Scale for MinOr Stroke (COSMOS), comparing post-stroke functioning at follow-up to the patient's functional status recorded at hospital admission (e.g. 0-6)
Time frame: Through study completion, an average of 54 months
Secondary Endpoint of Incidence of events and change from functional status
* Occurrence of stroke between randomisation and treatment initiation for both groups * Occurrence of further complications during follow-up: * Rate of any stroke (ischemic or haemorrhagic) as time to the first occurrence * Rate of death (any) as time to event endpoint * Rate of transient ischemic attack (TIA) as time to the first occurrence * Rate of ipsilateral transient ocular symptoms, e.g., Amaurosis fugax, as time to the first occurrence * Rate pf myocardial infarction as time to the first occurrence * Rate of device- and procedure-related (S)AEs * Rate of plaque progression or re-stenosis requiring (further) treatment (e.g., carotid artery stenting, carotid endarterectomy) * Change in the modified Rankin Scale (mRS) score at 30±10 days and during annual status checks at 12-72 months, as compared to mRS pre-randomisation (Delta mRS) (e.g. mRS 0-6)
Time frame: Through study completion, an average of 54 months
Safety Endpoint as rate of symptomatic stroke, death, or myocardial infarktion as safety endpoint
Any symptomatic stroke, death, or myocardial infarction within 30 ± 10 days after randomisation, evaluated through blinded functional assessment based on in-hospital follow-up and/or telephone interviews with statistical comparison of the endovascular treatment arm to a performance goal derived from the best available evidence in previous stenting studies
Time frame: 30 ± 10 days after randomisation
Treatment Endpoints as rate of (Peri-)procedural complications
•(Peri-)procedural complications related to endovascular treatment, assessed up to in-hospital follow-up/discharge and based on clinical routine measurements * Examination of functional status (mRS - e.g. 0-6) and neurological status (NIHSS e.g. Number) * Symptomatic intracranial haemorrhage (SICH) defined as any intracranial haemorrhage causing any clinical deterioration and/or SICH as defined in SITS-MOST: Local or remote parenchymal hematoma type 2 on the imaging scan, plus neurological deterioration, as indicated by a score on the NIHSS ≥ 4 points, or leading to death * Lumen narrowing post-stent placement per NASCET criteria (%) * Major bleeding defined as occurring when at least one of the following conditions is met: * Fatal bleeding * Symptomatic bleeding in a critical organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular bleeding associated with compartment syndrome. * A hemoglobin drop of ≥2 g/dL.
Time frame: Periprocedural
Exploratory outcomes as rate of morphological changes
•Rate of morphological changes observed in high-risk plaques due to their progression and potential implications for patient management strategies at annual follow-up related to ultrasound examination
Time frame: Through study completion, an average of 54 months
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acandis GmbH