Intracranial Artery StenosisNCT06618222
Wingspan Stent System for Intracranial Artery Stenosis
An observational study of Intracranial Artery Stenosis and Stent, run by The First People's Hospital of Changzhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Intracranial Artery Stenosis, Stent, Endovascular Therapy
- What is being tested?
- Wingspan stent system
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2023to 10 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: symptomatic ICAS (stenosis rate of 70%-99%) with the Wingspan stent system between December 2022 and June 2023
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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;
- Pregnant/lactating female patients;
- Patients with cognitive impairment or mental diseases (except for those with cognitive impairment due to arterial stenosis);
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Ambispective, Multicenter Clinical Study to Evaluate the Safety and Efficacy of the Wingspan Stent System for Clinical Use
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.
Read the 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.
- Conditions
- Intracranial Artery Stenosis, Stent, Endovascular Therapy
- Being tested
- Wingspan stent system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wingspan stent systemDevice
All patients had received Percutaneous transluminal angioplasty and stenting with Wingspan stent system.
| Study group | Role | What they receive |
|---|---|---|
| Wingspan stent | All patients had received Percutaneous transluminal angioplasty and stenting with Wingspan stent system. Receives: Device: Wingspan stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after operation
Secondary outcomes (12)
Stent success / Procedure success
Stent success is defined as Wingspan is successfully implanted into the vascular site of the target lesion with balloon pretreatment and the delivery system was successfully withdrawn.
Procedure success is defined as a reduction in the degree of stenosis to ≤ 30% after the application of any interventional treatment method.
Measured: Immediately after operative
Rate of good functional outcomes measured by Modified Rankin Score (mRS)
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a "good"; functional outcome with a score ranging from 0-2.
Measured: 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
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Measured: 6 months after operation
Rate of all revascularization and target lesion revascularization
The proportion of patients who had revascularization in target lesion or not.
Measured: 30days, 31days to 6 months after operation
Symptomatic ISR within 6 months
Symptomatic ISR is defined as ISR associated with ischemic event in the territory.
Measured: within 6 months
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.
As a composite endpoint include any stroke or death within 30 days, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months after operation.
Measured: 30days, 31days to 6 months after operation
Any stroke or death within 30 days after operation
Any stroke, death means death from any cause, including stroke or cerebrovascular disease.
Measured: Within 30days after operation
Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel
The proportion of patients who had any stroke or died within 30 days after operation in association with stenting implantation.
Measured: Within 30days after operation
The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months after operation
There is clear imaging evidence to confirm that the target vessel area is occluded again, which leads to ischemic stroke.
Measured: 31days to 6 months after operation
The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months after operation
There is clear imaging evidence to confirm that outside the target vessel area is occluded again, which leads to ischemic stroke.
Measured: 31days to 6 months after operation
Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage
There is clear imaging evidence to confirm that the incidence of any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage.
Measured: 31days to 6 months after operation
All cause death
The proportion of patients who died from all causes is evaluated from 31 days to 6 months after operation.
Measured: 31days to 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start17 Oct 2023
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ya Deng, Principal investigator, The First People's Hospital of Changzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618222
- Sponsor's protocol ID
- Wingspan PMS
- Status last verified
- Feb 2025
- First submitted
- 26 Sep 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ambispective, Multicenter Clinical Study to Evaluate the Safety and Efficacy of the Wingspan Stent System for Clinical Use
- ClinicalTrials.gov ID
- NCT06618222
- Acronym / sponsor ID
- Wingspan PMS
- Conditions
- Intracranial Artery Stenosis, Stent, Endovascular Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wingspan stent | – | Device: Wingspan stent systemAll patients had received Percutaneous transluminal angioplasty and stenting with Wingspan stent system. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- symptomatic ICAS (stenosis rate of 70%-99%) with the Wingspan stent system between December 2022 and June 2023
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wingspan stent systemAll patients had received Percutaneous transluminal angioplasty and stenting with Wingspan stent system. | Device | Wingspan stent |
Primary outcome
The incidence of In-stent restenosis within 6 months after operation
Time frame: 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.
12 secondary outcomes
Stent success / Procedure success
Time frame: Immediately after operative
Rate of good functional outcomes measured by Modified Rankin Score (mRS)
Time frame: 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
Time frame: 6 months after operation
Rate of all revascularization and target lesion revascularization
Time frame: 30days, 31days to 6 months after operation
Symptomatic ISR within 6 months
Time frame: within 6 months
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.
Time frame: 30days, 31days to 6 months after operation
Any stroke or death within 30 days after operation
Time frame: Within 30days after operation
Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel
Time frame: Within 30days after operation
The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months after operation
Time frame: 31days to 6 months after operation
The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months after operation
Time frame: 31days to 6 months after operation
Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage
Time frame: 31days to 6 months after operation
All cause death
Time frame: 31days to 6 months after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya Deng principal investigator
The First People's Hospital of Changzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Artery Stenosis and Stent, run by The First People's Hospital of Changzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of In-stent restenosis within 6 months after operation (time frame: 6 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.