Carotid StenosisRICSICASNCT07412249
Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis
A study testing Remote ischemic conditioning in people with Carotid Stenosis, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Remote ischemic conditioning (RIC) has emerged as a promising non-invasive strategy to protect the brain, with evidence suggesting its benefit in patients with carotid artery stenting (CAS). However, the long-term benefit and safety of chronic RIC in this population remain unknown. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2026to 30 Nov 2027
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years old;
- Patients with symptomatic moderate to severe stenosis of the internal carotid artery;
- History of ipsilateral cerebral ischemic symptoms within the past 180 days;
- Planned for carotid artery stent;
- Essen Score ≥ 3;
- Modified Rankin Scale score of 0 or 1;
- Signed informed consent.
Who cannot join
- Uncontrolled severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg despite medication)
- Subclavian artery stenosis ≥ 50% or presence of subclavian steal syndrome
- Severe hematological disorders or significant coagulation abnormalities
- Contraindications to remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limbs, or peripheral vascular disease in the distal upper limbs
- Severe comorbid conditions with a life expectancy of less than 1 year
- Participation in another clinical trial within the past 3 months or ongoing participation
- Any other circumstances deemed by the investigator as unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
Hui-Sheng Chen, Ph.D., +86 13352452086, chszh@aliyun.com
About this study
Official title: Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis (RICSICAS): A Prospective, Randomized Controlled, Blind Endpoint, Single-Center Study
Remote ischemic conditioning (RIC) has emerged as a promising non-invasive strategy to protect the brain, with evidence suggesting its benefit in patients with carotid artery stenting (CAS). However, the long-term benefit and safety of chronic RIC in this population remain unknown. This trial aims to evaluate whether chronic RIC reduces the incidence of major vascular events and improves clinical outcomes in high-risk patients with carotid artery stenosis who received CAS.
- Conditions
- Carotid Stenosis
- Being tested
- Remote ischemic conditioning
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningDevice
The RIC protocol involves bilateral upper-arm cuff inflation to 200 mmHg (5-min inflation/5-min deflation, 5 cycles) performed 1-2 times daily, starting 3 days before CAS and continuing for 12 months post-procedure.
| Study group | Role | What they receive |
|---|---|---|
| RIC group | Experimental | The RIC protocol involves bilateral upper-arm cuff inflation to 200 mmHg (5-min inflation/5-min deflation, 5 cycles) performed 1-2 times daily, starting 3 days before CAS and continuing for 12 months post-procedure. Receives: Device: Remote ischemic conditioning |
| Control group | No intervention | no RIC treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to the first occurrence of any component of the composite endpoint within 12 months post-randomization
the composite endpoint includes ischemic stroke, hemorrhagic stroke, myocardial infarction [including coronary revascularization], TIA, or vascular death
Measured: 1 year
Secondary outcomes (12)
composite of periprocedural death, stroke, or myocardial infarction
Measured: 30±3 days
occurence of non-fatal stroke and TIA
Measured: 1 year
occurence of nonfatal myocardial infarction
Measured: 1 year
numbers of new silent cerebral infarcts on Magnetic Resonance Imaging
Measured: 1 year
occurence of ipsilateral (to the stented artery) nonfatal stroke and transient ischemic attack
Measured: 1 year
degree of in-stent restenosis (≥50%) on Computed Tomography Angiography
Measured: 1 year
change in collateral circulation status (assessed by Computed Tomography Angiography or Digital Subtraction Angiograph) from baseline to 12 months
Measured: 1 year
all-cause mortality
Measured: 1 year
changes in modified Rankin Scale (mRS) scores over time
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Measured: 1 year
occurrence of contrast staining on brain computerized tomography
Measured: 1 hours and 24 hours after carotid artery stenting
occurrence of cerebral hyperperfusion syndrome
Measured: 24 hours after carotid artery stenting
occurence of new infarct on brain magnetic resonance imaging
Measured: 24 hours after carotid artery stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start4 Mar 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412249
- Sponsor's protocol ID
- Y (2026) 14
- Acronym
- RICSICAS
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qiu J, Li W, Zhao YG, Wang JQ, Wang L, Chen HS. Remote ischemic conditioning plus stenting for symptomatic carotid artery stenosis (RICSICAS): rationale and design. Front Neurol. 2026 Sep 30;17:1915534. doi: 10.3389/fneur.2026.1915534. eCollection 2026.
PubMed 42876495
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis (RICSICAS): A Prospective, Randomized Controlled, Blind Endpoint, Single-Center Study
- ClinicalTrials.gov ID
- NCT07412249
- Acronym / sponsor ID
- RICSICAS / Y (2026) 14
- Conditions
- Carotid Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 17 Feb 2026 (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.
Remote ischemic conditioning (RIC) has emerged as a promising non-invasive strategy to protect the brain, with evidence suggesting its benefit in patients with carotid artery stenting (CAS). However, the long-term benefit and safety of chronic RIC in this population remain unknown. This trial aims to evaluate whether chronic RIC reduces the incidence of major vascular events and improves clinical outcomes in high-risk patients with carotid artery stenosis who received CAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIC group | Experimental | Device: Remote ischemic conditioningThe RIC protocol involves bilateral upper-arm cuff inflation to 200 mmHg (5-min inflation/5-min deflation, 5 cycles) performed 1-2 times daily, starting 3 days before CAS and continuing for 12 months post-procedure. |
| Control group | No intervention | –no RIC treatment |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 40 years old;
- Patients with symptomatic moderate to severe stenosis of the internal carotid artery;
- History of ipsilateral cerebral ischemic symptoms within the past 180 days;
- Planned for carotid artery stent;
- Essen Score ≥ 3;
Key exclusion criteria (7 listed)
- Uncontrolled severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg despite medication)
- Subclavian artery stenosis ≥ 50% or presence of subclavian steal syndrome
- Severe hematological disorders or significant coagulation abnormalities
- Contraindications to remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limbs, or peripheral vascular disease in the distal upper limbs
- Severe comorbid conditions with a life expectancy of less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioningThe RIC protocol involves bilateral upper-arm cuff inflation to 200 mmHg (5-min inflation/5-min deflation, 5 cycles) performed 1-2 times daily, starting 3 days before CAS and continuing for 12 months post-procedure. | Device | RIC group |
Primary outcome
time to the first occurrence of any component of the composite endpoint within 12 months post-randomization
Time frame: 1 year
the composite endpoint includes ischemic stroke, hemorrhagic stroke, myocardial infarction [including coronary revascularization], TIA, or vascular death
12 secondary outcomes
composite of periprocedural death, stroke, or myocardial infarction
Time frame: 30±3 days
occurence of non-fatal stroke and TIA
Time frame: 1 year
occurence of nonfatal myocardial infarction
Time frame: 1 year
numbers of new silent cerebral infarcts on Magnetic Resonance Imaging
Time frame: 1 year
occurence of ipsilateral (to the stented artery) nonfatal stroke and transient ischemic attack
Time frame: 1 year
degree of in-stent restenosis (≥50%) on Computed Tomography Angiography
Time frame: 1 year
change in collateral circulation status (assessed by Computed Tomography Angiography or Digital Subtraction Angiograph) from baseline to 12 months
Time frame: 1 year
all-cause mortality
Time frame: 1 year
changes in modified Rankin Scale (mRS) scores over time
Time frame: 1 year
occurrence of contrast staining on brain computerized tomography
Time frame: 1 hours and 24 hours after carotid artery stenting
occurrence of cerebral hyperperfusion syndrome
Time frame: 24 hours after carotid artery stenting
occurence of new infarct on brain magnetic resonance imaging
Time frame: 24 hours after carotid artery stenting
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 3 Apr 2026.
- Derived from this study: PubMed 42876495Qiu J, Li W, Zhao YG, Wang JQ, Wang L, Chen HS. Remote ischemic conditioning plus stenting for symptomatic carotid artery stenosis (RICSICAS): rationale and design. Front Neurol. 2026 Sep 30;17:1915534. doi: 10.3389/fneur.2026.1915534. eCollection 2026.
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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.
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Carotid Stenosis, run by General Hospital of Shenyang Military Region at 1 site in China.
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 7 inclusion and 7 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 3 Apr 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to the first occurrence of any component of the composite endpoint within 12 months post-randomization (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07412249, which also lists 1 linked publication.
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 3 Apr 2026.