Status:
ACTIVE_NOT_RECRUITING
SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis
Lead Sponsor:
B. Braun Medical International Trading Company Ltd.
Conditions:
Stroke
Intracranial Atherosclerotic Stenosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study is aiming to evaluate the safety and efficacy of SeQuent® Please CIS in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis and restenosis after interventional t...
Detailed Description
This study includes 2 sub-studies, sub-study A and sub-study B, namely. Sub-study A is a prospective, multicenter, randomized controlled, superior clinical trial to evaluate the safety and effectiven...
Eligibility Criteria
Inclusion
- Aged 18 to 80 years old (including boundary value), gender is not limited;
- The target lesion of the patient is a symptomatic intracranial atherosclerotic stenosis lesion (for part A only) or restenosis lesions after interventional therapy (for part B only);
- Symptomatic intracranial arterial stenosis (intracranial segment of internal carotid artery (Petrous segment and above), middle cerebral artery, intracranial segment of vertebral artery, basilar artery, etc.) within 6 months, the degree of stenosis of the diseased artery is between 70% and 99% (WASID method);
- Patients with symptoms occurring more than once (symptoms refer to stroke or transient ischemic attacks) after intensive drug therapy of internal medicine (including antiplatelet therapy, antihypertensive therapy, hypoglycemic therapy and lipid-lowering therapy);
- The intracranial arterial stenosis lesion to be treated is a single lesion;
- Patients with at least 1 risk factor for intracranial atherosclerotic plaque, including previous or existing hypertension, hyperlipidemia, diabetes, smoking;
- Preoperative mRS ≤ 2, and NIHSS≤8;
- Patients whose life expectancy is greater than 12 months as assessed by the investigator.
- Patients or their guardians can understand the trial purpose, voluntarily participate in and sign the informed consent form, and can accept follow-up visits.
Exclusion
- Severe calcification in the target vessel, severe distortion of the target vessel or anatomical factors that make it hard for interventional devices to be in place;
- Ischemic symptoms are only associated with branch events;
- Severe stenosis or occlusion of tandem extracranial or intracranial vessels at the proximal or distal end of the target vessel;
- Angioplasty or stenting procedures is planned for extracranial vascular lesions with tandem intracranial vessels;
- History of endarterectomy in the extracranial segment of carotid artery and vertebral artery within 30 days;
- The target vessel has previously been treated with stenting or angioplasty or other mechanical devices (for Part A only);
- Acute or subacute intraluminal thrombosis is found in the target vessel;
- Patients with intracranial stenosis combined with aneurysm, intracranial tumor or intracranial vascular malformation, or intracranial arterial spasm without significant stenosis;
- Intracranial hemorrhage (cerebral intraparenchymal hemorrhage, massive subarachnoid hemorrhage, and subdural/epidural hemorrhage) within 3 months;
- There are cardiogenic stroke or risk factors that may contribute to cardioembolism, such as fibrillation, left ventricular thrombosis or myocardial infarction within 6 weeks,;
- Patients with abnormal coagulation function or bleeding tendency (e.g., international normalized ratio (INR) \> 1.5);
- Patients with known hypersensitivity to iodine contrast medium, paclitaxel, or iopromide;
- Patients who are participating in clinical trials of other drugs or devices;
- Other conditions that the investigator deems the patient unsuitable for enrollment.
Key Trial Info
Start Date :
March 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2025
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT06047964
Start Date
March 23 2023
End Date
January 23 2025
Last Update
October 21 2024
Active Locations (9)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
2
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
3
Nanyang Central Hospital
Nanyang, Henan, China
4
The First Hospital of Jilin University
Changchun, Jilin, China