Status:
COMPLETED
The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease
Lead Sponsor:
Sinomed Neurovita Technology Inc.
Collaborating Sponsors:
Changhai Hospital
Conditions:
Intracranial Arterial Diseases
Stent Restenosis
Eligibility:
All Genders
30-80 years
Phase:
NA
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 symptom...
Eligibility Criteria
Inclusion
- 30 to 75 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 target lesion reference diameter must be visually estimated to be ≥2.0 mm and \<4.5mm in diameter, and lesion length of ≤34 mm;
- mRS \< 3;
- 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
- 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 only showed perforating infarction in the target lesion area;
- 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;
- 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\>180mmHg or diastolic blood pressure\>110mmHg)；
- Known liver or renal insufficiency (ALT\> 3x upper limit or AST \> 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;
- Inapplicable for intravascular stenting treatment as per investigators judgment.
Key Trial Info
Start Date :
July 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2024
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05217459
Start Date
July 4 2022
End Date
March 29 2024
Last Update
May 21 2025
Active Locations (14)
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1
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
2
The First Hospital of Jilin University
Changchun, China
3
The First People's Hospital of Changzhou
Changzhou, China
4
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China