CompletedNot Applicable

Wingspan Stent System for Intracranial Artery Stenosis

China43 participantsStarted 2023-10-17

Plain-language 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.

Who can participate

Age range30 Years – 80 Years

SexALL

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Inclusion criteria

✓. 30 to 80 years of age;
✓. Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery;
✓. Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery;
✓. The target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment;
✓. The patient voluntarily underwent treatment with the Wingspan stent system;
✓. mRS \< 3 (if any);
✓. The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure;
✓. Willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow ups, etc. according to the requirements of the clinical protocol during the clinical trial.

Exclusion criteria

✕. The target vessels was complete occlusion;
✕. \>70% stenosis observed at the intracranial large-vessel distal to the target vessel or \>70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel;
✕. Preoperative magnetic resonance showed perforating infarction in the target lesion area;
✕. Preoperative CT showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment Chronic subdural hematoma ≥5mm;
✕. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery;
✕. CT showed Severe calcified lesions;
✕. Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation);
✕. Non-atherosclerosis lesions;

What they're measuring

The incidence of In-stent restenosis within 6 months after operation

Timeframe: 6 months after operation

Trial details

NCT IDNCT06618222

SponsorThe First People's Hospital of Changzhou

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-02-10

View on ClinicalTrials.gov More Intracranial Artery Stenosis trials