Stent Placement Clinical Trials

Clinical trials related to Stent Placement Procedure

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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Städtisches Klinikum Solingen
RECRUITING
Solingen
Contact Information
Primary
Acandis GmbH
info@acandis.com
+49 (0) 7231 - 155 00 171
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2032-06
Participants
Target number of participants: 536
Treatments
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
Sponsors
Leads: Acandis GmbH

This content was sourced from clinicaltrials.gov