Clinical trial NCT05217459: The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease
Official title: A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of an Intracranial Self-expanding Drug Eluting Stent System for Symptomatic Intracranial Atherosclerotic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Arterial Diseases
Stent Restenosis
Percutaneous Transluminal Angioplasty
Keywords: Self-expanding intracranial stent
Symptomatic Intracranial Atherosclerotic Disease
In-stent restenosis
Lead sponsor: Sinomed Neurovita Technology Inc.
Sponsor class: INDUSTRY
Collaborators: name: Changhai Hospital
First posted: 2022-02-01
Enrollment: 128
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.

Detailed description: This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of intracranial self-expanding drug stent system in the treatment of symptomatic intracranial atherosclerotic stenosis. A total of 128 patients are planned to be included. The primary endpoint is the incidence of In-stent restenosis at 6 months after operation (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.). All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.

Eligibility criteria: Inclusion Criteria:

1. 30 to 75 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 target lesion reference diameter must be visually estimated to be ≥2.0 mm and \<4.5mm in diameter, and lesion length of ≤34 mm;
6. mRS \< 3;
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 only showed perforating infarction in the target lesion area;
4. Preoperative CT or MRI 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\>180mmHg or diastolic blood pressure\>110mmHg)；
14. Known liver or renal insufficiency (ALT\> 3x upper limit or AST \> 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;
19. Inapplicable for intravascular stenting treatment as per investigators judgment.

Primary outcomes:
measure: The incidence of In-stent restenosis within 6 months after operation
timeFrame: 6 months after operation
Secondary outcomes:
measure: Stent success
timeFrame: Immediately after operative
measure: Procedure success
timeFrame: Immediately after operative
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 good functional outcomes measured by Modified Rankin Score (mRS)
timeFrame: 30days, 6 months, 1 year after operation
measure: Rate of all revascularization and target lesion revascularization
timeFrame: 30days, 31days to 6 months, 1 year 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, 1 year after operation.
timeFrame: 30days, 31days to 6 months, 1 year after operation
measure: Any stroke or death within 30 days after operation
timeFrame: Within 30 days after operation
measure: Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel
timeFrame: Within 30 days after operation
measure: The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.
timeFrame: 31days to 6 months, 1 year after operation
measure: The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months, 1 year after operation.
timeFrame: 31 days to 6 months, 1 year after operation
measure: Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage
timeFrame: 31 days to 6 months, 1 year after operation
measure: All cause death
timeFrame: 31days to 6 months, 1 year after operation
measure: Adverse events or severe adverse event
timeFrame: 31 days to 6 months, 1 year after operation
measure: Incidence of device defects
timeFrame: During operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
city: Hangzhou
country: China
facility: Hangzhou First people's Hospital, Zhejiang University School of Medicine
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC Anhui provincial hospital
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Shanghai Fourth People's Hospital
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
city: Yantai
country: China
facility: Yantai Yu Huang Ding hospital
city: Zhengzhou
country: China
facility: The First Affiliated hospital of Zhengzhou hospital
Study officials:
affiliation: Changhai Hospital
name: jianming Liu, M.D/Ph.D
role: PRINCIPAL_INVESTIGATOR
References: