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

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: Terminated
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: RIC; Other: Guideline-based therapy; Device: Sham

• Study Type: Interventional
• Enrollment (Actual): 458
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Distribution of 90-day mRS scores	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

Outcome Measure	Measure Description	Time Frame
Distribution of 360-day mRS scores (to be analyzed separately in the subsequent study)	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	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	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	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	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	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	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	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

• Sponsor: The First Affiliated Hospital of University of Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2025
• Primary Completion (Actual): February 28, 2026
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Occlusion; stenosis; Acute Ischemic Stroke; Remote ischemic conditioning; anterior circulation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathological Conditions, Anatomical; Chemically-Induced Disorders; Poisoning; Stroke; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Constriction, Pathologic; Bites and Stings
• Other Study ID 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