Wingspan Stent System for Intracranial Artery Stenosis

NCT06618222 | Completed

• 1 other identifier: Wingspan PMS
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Artery Stenosis; Stent; Endovascular Therapy

Outcome Measures

Primary Outcomes (1)

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

  In-Stent Restenosis (ISR) is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.

  6 months after operation

Secondary Outcomes (12)

• Stent success / Procedure success

  Immediately after operative

• Rate of good functional outcomes measured by Modified Rankin Score (mRS)

  30days, 6 months after operation

• Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up

  6 months after operation

• Rate of all revascularization and target lesion revascularization

  30days, 31days to 6 months after operation

• Symptomatic ISR within 6 months

  within 6 months

Study Arms (1)

Wingspan stent

All patients had received Percutaneous transluminal angioplasty and stenting with Wingspan stent system.

Device: Wingspan stent system

Interventions

Wingspan stent system DEVICE

All patients had received Percutaneous transluminal angioplasty and stenting with Wingspan stent system.

Wingspan stent

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks);
• Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;
• 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;
• Hemoglobin \<100g/L, platelet count \<100\*109/L, International normalized ratio (INR) \>1.5 (irreversible) or uncorrectable hemorrhagic factors;
• Uncontrollable severe hypertension (systolic blood pressure\>180 millimetres of mercury (mmHg) or diastolic blood pressure\>110mmHg);
• Known liver or renal insufficiency (aspartate transaminase (ALT)\> 3x upper limit or aspartate transaminase \> 3x upper limit, Serum creatinine#250μmol/L);
• Life expectancy \< 1 year;

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

Study Sites (1)

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Location

Study Officials

• Ya Deng

  The First People's Hospital of Changzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 17, 2023
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-02

Locations

CN (1)