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Efficacy and Safety of Enhanced External Counterpulsation in Symptomatic Intracranial Atherosclerotic Stenosis: A Single-Center Prospective Exploratory Trial(EECP-SICAS Trial)

Efficacy and Safety of Enhanced External Counterpulsation in Symptomatic Intracranial Atherosclerotic Stenosis: A Single-Center Prospective Exploratory Trial(EECP-SICAS Trial)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102104
Enrollment
Unknown
Registered
2025-05-08
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Intracranial Atherosclerotic Stenosis

Interventions

Experimental group:Best medical therapy combined with enhanced external counterpulsation therapy

Sponsors

Guangzhou Red Cross Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1)Between the ages of 18 and 80, male or female; 2) Clinically diagnosed as symptomatic intracranial atherosclerotic stenosis; 3) The degree of intracranial vascular stenosis is 50%-99%, and meets one of the following conditions: ischemic stroke and/or TIA that occurred within 3 months or 6 months, the lesion is located in the blood supply area of the responsible artery or the symptoms of TIA attack match the neurological function of the brain tissue in the blood supply area of the responsible artery; Imaging evidence of ischemia in brain tissue in the narrowed area (MRI-DWI sequence shows acute cerebral infarction lesions corresponding to symptoms (high signal on DWI, low signal on ADC), CT/MRI perfusion imaging evaluates abnormal blood perfusion in the ischemic area (such as prolonged peak time); 4) Modified Rankin Scale (mRS) score before stroke: 0-1 point; 5) Obtain the informed consent.

Exclusion criteria

Exclusion criteria: 1) Large-area cerebral infarction with severe neurological deficits, with a NIHSS score more than 24 points, especially those combined with consciousness disorders, severe cerebral edema or unstable conditions; 2) Patients who need endovascular treatment urgently and in the near future (within 90 days); 3) Cerebral embolism, including those caused by cardiogenic, non-cardiogenic and emboli of unknown origin; 4) Intracranial and extracranial vasculitis caused by various reasons; 5) Cerebral infarction caused by Moyamoya disease and arterial dissection, traumatic cerebral infarction, and cerebral infarction of unknown cause; 6) Cerebral hemorrhage caused by various reasons currently includes intracranial hemorrhage and subarachnoid hemorrhage. 7) Other hemorrhagic diseases or obvious bleeding tendencies; 8) Moderate to severe aortic insufficiency; 9) Significant pulmonary arterial hypertension; 10) Decompensated heart failure 11) Active thrombophlebitis, deep vein thrombosis of the lower extremities; 12) There are infection foci or other active infection lesions in the counterpulsating limb; 13) Uncontrolled hypertension (BP>180/100 MMHG); 14) Uncontrolled arrhythmias (P > 100 beats per minute), and other electrocardiogram abnormalities that may interfere with electrocardiogram triggering; 15) Malignant tumors in non-clinical remission stage; 16) Pregnant or lactating women; 17) Unstable vital signs; 18) Those who cannot cooperate (or are not suitable) to undergo DSA, MR, and TCD examinations; 19) Other individuals who are not suitable for EECP therapy.

Design outcomes

Primary

MeasureTime frame
Recurrence rate of stroke;The improvement rate of collateral circulation in the responsible vascular area;The incidence of symptomatic intracranial hemorrhage;

Secondary

MeasureTime frame
MRS Score;The improvement rate of the degree of stenosis of the responsible blood vessels;The improvement rate of cerebral blood flow in the responsible vascular area;The improvement rate of cerebral blood flow velocity in the responsible vascular area;The improvement rate of brain tissue perfusion;All-cause mortality rate;Serious adverse events;

Countries

China

Contacts

Public ContactHongxing Fan

Guangzhou Red Cross Hospital of Jinan University

fhxchina@126.com+86 189 2890 0487

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026