Carotid Artery DiseaseCARESTARNCT07166731
High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)
An observational study of Carotid Artery Disease and Symptomatic Carotid Artery Stenosis, run by Acandis GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Disease, Symptomatic Carotid Artery Stenosis, Carotid Artery Stenting
- How many people
- 536 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2026to Jun 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Städtisches Klinikum Solingen
Solingen, North Rhine-Westphalia, 42653
PD Dr. Hannes Nordmeyer, Nordmeyer.Hannes@klinikumsolingen.de
Prof. Dr. Marcel Dihné, dihne.marcel@klinikumsolingen.de
About this study
Official title: High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC) - CARESTAR
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.
Read the 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 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.
- 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
- Medical subject headings
- Carotid Artery Diseases, Carotid Artery Thrombosis, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 54 months
Secondary outcomes (2)
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)
Measured: 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)
Measured: Through study completion, an average of 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Mar 2026
- Primary completion31 May 2032 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acandis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166731
- Sponsor's protocol ID
- CARESTAR Study
- Acronym
- CARESTAR
- Status last verified
- Mar 2026
- First submitted
- 7 Aug 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC) - CARESTAR
- ClinicalTrials.gov ID
- NCT07166731
- Acronym / sponsor ID
- CARESTAR / CARESTAR Study
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Acandis GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 May 2032 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (15 listed)
- 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
- 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):
- Presence of carotid web characterized as shelf-like/linear, smooth filling defects
Key exclusion criteria (19 listed)
- 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
- Predominantly calcified Plaques (≥50% calcified plaque components on CT-Angio)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Endpoint as rate of events of ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia analysed as time to first occurence
Time frame: Through study completion, an average of 54 months
Ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia during follow-up analysed as time to first occurence
2 secondary outcomes
Secondary Endpoint of Incidence of events and change from functional status
Time frame: Through study completion, an average of 54 months
Secondary Endpoint of Incidence of events and change from functional status
Time frame: Through study completion, an average of 54 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Complicated Carotid Artery Plaques as a Cause of Cryptogenic StrokeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Disease and Symptomatic Carotid Artery Stenosis, run by Acandis GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Acandis GmbH (+49 (0) 7231 - 155 00 171, info@acandis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint as rate of events of ipsilateral recurrent ischemic stroke or ipsilateral retinal artery ischemia analysed as time to first occurence (time frame: Through study completion, an average of 54 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.