Safety and Efficacy of Remote Ischemic Conditioning in Patients With Severe Stenosis or Occlusion of Anterior Intracranial Circulation Vessels (RICASO)

June 8, 2026 updated by: Wei Hu, The First Affiliated Hospital of University of Science and Technology of China
The primary purpose of this study is to examine whether remote ischemic treatment can better the 90 - day neurological outcomes in acute ischemic stroke patients having severe stenosis or occlusion of anterior intracranial circulation vessels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
458

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Hefei, China
        • The First Affiliated Hospital of University of Science and Technology of China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age is 18 years old or above.
  2. Severe stenosis (70% - 99%) or occlusion of anterior intracranial circulation vessels, mainly including the intracranial segment of the internal carotid artery, middle cerebral artery (M1, M2) and anterior cerebral artery (A1, A2), which is confirmed by digital subtraction angiography (DSA), computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
  3. Patients with clinically diagnosed acute ischemic stroke who received remote ischemic treatment within 72 hours after the onset.
  4. The NIHSS score ranges from 4 to 24.
  5. The mRS score before stroke is less than or equal to 1.
  6. informed consent.

Exclusion Criteria:

  1. Patients with vessel recanalization after mechanical thrombectomy (TICI grade ≥ 2b).
  2. Patients planning to receive intracranial endovascular treatment within 3 months.
  3. Patients diagnosed with acute posterior circulation cerebral infarction.
  4. Symptoms caused by non - culprit vessels.
  5. Ipsilateral extracranial vessel stenosis ≥ 70%.
  6. Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and uncontrollable by antihypertensive drugs.
  7. Intracranial tumors, arteriovenous malformations or aneurysms.
  8. Cerebral venous thrombosis or stenosis.
  9. Severe coagulation abnormalities.
  10. Any contraindications to remote ischemic conditioning: severe soft tissue injury, fracture or vascular injury of the upper limb, perivascular lesions of the distal upper limb, etc.
  11. Patients with any serious diseases and a life expectancy of less than 1 year.
  12. Patients who participated in other clinical trials within 3 months before enrollment or are currently participating in other clinical trials.
  13. Patients who cannot be followed up (such as those without a fixed residence, overseas patients, etc.).
  14. Pregnant or lactating women.
  15. Patients who have previously received remote ischemic treatment or similar treatments.
  16. Patients whom the researchers consider unsuitable for this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RIC group+Guideline-based therapy
RIC is given twice a day with 200mmHg pressure.
Device: RIC
Remote Ischemic Conditioning is given twice a day with 200mmHg pressure,last for 7 to 10 days.
Other: Guideline-based therapy
Guideline-based therapy
Active Comparator: Sham group+Guideline-based therapy
RIC is given twice a day with 60mmHg pressure.
Other: Guideline-based therapy
Guideline-based therapy
Device: Sham
RIC is given twice a day with 60mmHg pressure, last for 7 to 10 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Distribution of 90-day mRS scores
Time Frame: 90±14 days after procedure
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
90±14 days after procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distribution of 360-day mRS scores (to be analyzed separately in the subsequent study)
Time Frame: 90±14 days after procedure
The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death
90±14 days after procedure
Proportion of patients with functional independence outcome (mRS 0-1) at 90-day
Time Frame: 90 (± 14 days) after procedure
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
90 (± 14 days) after procedure
Proportion of patients with functional independence outcome (mRS 0-2) at 90-day
Time Frame: 90 (± 14 days) after procedure
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
90 (± 14 days) after procedure
Proportion of patients with functional independence outcome (mRS 0-3) at 90-day
Time Frame: 90 (± 14 days) after procedure
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
90 (± 14 days) after procedure
The proportion of early neurological deterioration
Time Frame: 7 (± 1 day) after procedure
It is defined as an increase of ≥ 2 points in the NIHSS score on the 7th day compared to the baseline (excluding intracerebral hemorrhage).
7 (± 1 day) after procedure
Activities of Daily Living of Participants Assessed by Bathel Index at 90-day
Time Frame: 90 (± 14 days) after procedure
10 rating items, each of which is categorized into 2-3 out of 5 levels: Unable, Needs major help, Needs help, Needs minor help, and Independent, and each item has a different score for each level. Independence was positively correlated with the final score.
90 (± 14 days) after procedure
Activities of Daily Living of Participants Assessed by Bathel Index at 360-day
Time Frame: 360(± 14 days) after procedure
10 rating items, each of which is categorized into 2-3 out of 5 levels: Unable, Needs major help, Needs help, Needs minor help, and Independent, and each item has a different score for each level. Independence was positively correlated with the final score.
360(± 14 days) after procedure
Incidences of adverse cardiovascular and cerebrovascular events, and recurrent ischemic events
Time Frame: 360 (± 14 days) after procedure
Adverse cardiovascular and cerebrovascular events include myocardial infarction, heart failure, severe arrhythmia, cerebral infarction, cerebral hemorrhage, transient ischemic attack (TIA), and recurrent ischemic events include recurrent myocardial infarction and recurrent cerebral infarction.
360 (± 14 days) after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of University of Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RICASO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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