Wingspan Stent System for Intracranial Artery Stenosis

Last updated: April 22, 2025
Sponsor: The First People's Hospital of Changzhou
Overall Status: Completed

Phase

N/A

Condition

Claudication

Stent

Treatment

Wingspan stent system

Clinical Study ID

NCT06618222
Wingspan PMS
  • Ages 30-80
  • All Genders

Study Summary

The primary objective of this trial is to evaluate the safety and efficacy of Wingspan Stent System in "real world" patients with intracranial atherosclerotic stenosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 30 to 80 years of age;

  2. Patients with symptomatic intracranial atherosclerotic stenosis who failedantiplatelet therapy or poor collateral circulation compensation or hypoperfusion inthe territory of the culprit artery;

  3. Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in targetintracranial artery;

  4. The target lesion was in the internal carotid artery (intracranial segment), middlecerebral artery, vertebral artery (intracranial segment), basilar artery, and it wasa single lesion that required surgical treatment;

  5. The patient voluntarily underwent treatment with the Wingspan stent system;

  6. mRS < 3 (if any);

  7. The onset of the latest transient ischemic attack (TIA) was not limited or ischemicstroke occurred within 2 weeks prior to stenting procedure;

  8. Willingness to participate in this clinical trial and signing the consent form, andbe able to complete the corresponding inspections, follow ups, etc. according to therequirements of the clinical protocol during the clinical trial.

Exclusion

Exclusion Criteria:

  1. The target vessels was complete occlusion;

  2. >70% stenosis observed at the intracranial large-vessel distal to the target vesselor >70% stenosis observed at the intracranial/extracranial large-vessel proximal tothe target vessel;

  3. Preoperative magnetic resonance showed perforating infarction in the target lesionarea;

  4. Preoperative CT showed that there was hemorrhage transformation after infarction inthe target vessel area, or a history of primary cerebral hemorrhage, or a history ofsubarachnoid, subdural and epidural hemorrhage within 30 days before operation, orthere was no treatment Chronic subdural hematoma ≥5mm;

  5. Hospitalized surgical treatment within 30 days before operation, or plannedhospitalized surgical treatment within 6 months after surgery;

  6. CT showed Severe calcified lesions;

  7. Previously received endovascular treatment or surgical intervention at the targetvessel (except for patients with simple balloon dilatation);

  8. Non-atherosclerosis lesions;

  9. Patients with potential sources of cardiac embolism (such as atrial fibrillation,left ventricular thrombosis, myocardial infarction within 6 weeks);

  10. Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;

  11. Known hypersensitivity to aspirin, heparin, clopidogrel, rapamycin (sirolimus),lactic acid polymer, poly-n-butyl methacrylate, nickel-titanium alloy, orcontraindications to anesthetics and contrast agents;

  12. Hemoglobin <100g/L, platelet count <100*109/L, International normalized ratio (INR) >1.5 (irreversible) or uncorrectable hemorrhagic factors;

  13. Uncontrollable severe hypertension (systolic blood pressure>180 millimetres ofmercury (mmHg) or diastolic blood pressure>110mmHg);

  14. Known liver or renal insufficiency (aspartate transaminase (ALT)> 3x upper limit oraspartate transaminase > 3x upper limit, Serum creatinine#250μmol/L);

  15. Life expectancy < 1 year;

  16. Pregnant/lactating female patients;

  17. Patients with cognitive impairment or mental diseases (except for those withcognitive impairment due to arterial stenosis);

  18. Patients who were participated in other clinical trials within 3 months orparticipating in other clinical trials who had not yet reached the primary clinicalendpoint.

Study Design

Total Participants: 43
Treatment Group(s): 1
Primary Treatment: Wingspan stent system
Phase:
Study Start date:
October 17, 2023
Estimated Completion Date:
February 10, 2025

Study Description

This study is an ambispective, multicenter clinical study design and consecutively included patients with symptomatic intracranial atherosclerotic arterial stenosis (stenosis rate of 70%-99%) with the Wingspan stent system between December 2022 and June 2023.

All included patients underwent preoperative DSA to clarify the diagnosis, and were followed up within 6 months after the procedure with DSA to clarify in-stent restenosis. The main observations endpoints included revascularization within 30 days after the procedure, revascularization within 31 days to 6 months, symptomatic in-stent restenosis within 6 months after the procedure, stroke or death within 30 days or ischaemic stroke in the qualifying artery beyond 30 days through 6 months, stroke (ischaemic or hemorrhagic stroke) or death in the qualifying artery within 30 days, ischaemic stroke that occurs beyond the lesion arterial territory from 31 days to 6 months after the procedure, any cerebral parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage from 31 days to 6 months after the procedure, all-cause death (cerebrovascular death and non-cerebrovascular death) from 31 days to 6 months after the procedure.

Connect with a study center

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu
    China

    Site Not Available

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