SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis (NCT06047964) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis
China281 participantsStarted 2023-03-23
Plain-language 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 therapy.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
✕
What they're measuring
1
restenosis incidence of target lesion
Timeframe: 6 months post-procedure
Trial details
NCT IDNCT06047964
SponsorB. Braun Medical International Trading Company Ltd.
. 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;