Clinical trial NCT06618222: Wingspan Stent System for Intracranial Artery Stenosis
Official title: An Ambispective, Multicenter Clinical Study to Evaluate the Safety and Efficacy of the Wingspan Stent System for Clinical Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Artery Stenosis
Stent
Endovascular Therapy
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 43
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: symptomatic ICAS (stenosis rate of 70%-99%) with the Wingspan stent system between December 2022 and June 2023

Brief summary: The primary objective of this trial is to evaluate the safety and efficacy of Wingspan Stent System in \&#34;real world\&#34; patients with intracranial atherosclerotic stenosis.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. 30 to 80 years of age;
2. Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery;
3. Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery;
4. 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;
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 ischemic stroke occurred within 2 weeks prior to stenting procedure;
8. 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:

1. The target vessels was complete occlusion;
2. \>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;
3. Preoperative magnetic resonance showed perforating infarction in the target lesion area;
4. 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;
5. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery;
6. CT showed Severe calcified lesions;
7. Previously received endovascular treatment or surgical intervention at the target vessel (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, or contraindications 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 of mercury (mmHg) or diastolic blood pressure\>110mmHg);
14. Known liver or renal insufficiency (aspartate transaminase (ALT)\> 3x upper limit or aspartate 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 with cognitive impairment due to arterial stenosis);
18. Patients who were participated in other clinical trials within 3 months or participating in other clinical trials who had not yet reached the primary clinical endpoint.

Primary outcomes:
measure: The incidence of In-stent restenosis within 6 months after operation
timeFrame: 6 months after operation
Secondary outcomes:
measure: Stent success / Procedure success
timeFrame: Immediately after operative
measure: Rate of good functional outcomes measured by Modified Rankin Score (mRS)
timeFrame: 30days, 6 months after operation
measure: Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up
timeFrame: 6 months after operation
measure: Rate of all revascularization and target lesion revascularization
timeFrame: 30days, 31days to 6 months after operation
measure: Symptomatic ISR within 6 months
timeFrame: within 6 months
measure: Any stroke or death within 30 days after operation, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months after operation.
timeFrame: 30days, 31days to 6 months after operation
measure: Any stroke or death within 30 days after operation
timeFrame: Within 30days after operation
measure: Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel
timeFrame: Within 30days after operation
measure: The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months after operation
timeFrame: 31days to 6 months after operation
measure: The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months after operation
timeFrame: 31days to 6 months after operation
measure: Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage
timeFrame: 31days to 6 months after operation
measure: All cause death
timeFrame: 31days to 6 months after operation
Other outcomes:
Locations:
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
Study officials:
affiliation: The First People's Hospital of Changzhou
name: Ya Deng
role: PRINCIPAL_INVESTIGATOR
References: