Remote Ischemic Conditioning Combined With Endovascular Stenting for Symptomatic Intracranial Atherosclerotic Stenosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTianjin Huanhu Hospital

About this trial

The purpose of this registry is to evaluate the safety and efficacy of RIC for patients with symptomatic intracranial atherosclerotic stenosis (sICAS) undergoing endovascular therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient admitted from Jan. 1st 2023 to Jan. 1st 2025;

Age ≥ 18;

Intracranial atherosclerosis stenosis measured as ≥70% by digital subtraction angiography or by other noninvasive methods, such as transcranial doppler, computed tomography angiography, or magnetic resonance angiography;

A history of stroke/transient ischemic attack attributed to ICAS;

Disqualifiers

Stenosis of other causes;

Prior ipsilateral stroke with residual deficits;

Uncontrolled hypertension (defined as systolic blood pressure ≥200 mm Hg despite medications at enrollment);

Peripheral vascular disease (especially subclavian arterial and upper limb artery stenosis or occlusion).

Trial population

This study prospectively collects data of patients with sICAS who receive endovascular therapy in the Comprehensive Neurovascular Ward of Tianjin Huanhu Hospital. Depending on their preference, patients enrolled in this registry will be divided into 2 groups, receiving either endovascular therapy alone or endovascular therapy plus RIC respectively.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Remote Ischemic Conditioning

    Other intervention

    Remote ischaemic conditioning (RIC) refers to a process whereby periods of intermittent ischemia, typically via the cyclical application of a blood pressure cuff to a limb at above systolic pressure, confers systemic protection against ischemia in spatially distinct vascular territories.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Endovascular therapy0 interventions
Group B: Endovascular therapy+Remote ischemic conditioning1 intervention

Trial outcomes

Primary outcomes

1

The presence of ≥1 new brain lesions on DWI within 48 hours after endovascular stenting

A new brain lesion was diagnosed if increased signal intensity was visible on DWI with correspondent decreased signal on apparent diffusion coefficient.

Time frame
48 hours
2

Incidence of clinical adverse events within 12 months after endovascular stenting

Clinical adverse events include ischemic stroke, TIA, acute myocardial infarction,hemorrhagic stroke, hyperperfusion syndrome, and death.

Time frame
12 months

Secondary outcomes

1

Number of new brain lesions on DWI within 48 hours after endovascular stenting

The number of new DWI lesions

Time frame
48 hours
2

The volume of new brain lesions on DWI within 48 hours after endovascular stenting

The volume of single lesions, and volume of all lesions were measured on DWI.

Time frame
48 hours
3

National Institutes of Health Stroke Scale (NIHSS) scores at 12 months

The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

Time frame
12 months
4

Modified Rankin Scale (mRS) scores at 12 months

The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.functional disability.

Time frame
12 months

Other outcomes

Sponsors and contacts

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