Clinical trial NCT06047964: SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis
Official title: A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the Intracranial Paclitaxel Drug-eluting Balloon Catheters (SeQuent® Please CIS) in the Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis and Restenosis After Interventional Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Intracranial Atherosclerotic Stenosis
Keywords: symptomatic intracranial atherosclerotic stenosis
DCB
Lead sponsor: B. Braun Medical International Trading Company Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 therapy.

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 effectiveness of paclitaxel drug-releasing intracranial balloon catheter (SeQuent® Please CIS) in the treatment of symptomatic intracranial atherosclerotic stenosis.

Sub-study B is a prospective, multicenter, single-arm clinical trial designed to evaluate the safety and efficacy of paclitaxel drug-releasing intracranial balloon catheter (SeQuent® Please CIS) for the treatment of restenosis following interventional treatment for symptomatic intracranial atherosclerotic stenosis.

A total of 277 subjects are expected to be enrolled, including 252 subjects in sub-study A and 25 subjects in sub-study B. Subjects enrolled in sub-study A will be randomized into the study arm and the control arm with the ratio of 1:1. The study arm will be treated with SeQuent® Please CIS (paclitaxel drug-releasing intracranial balloon catheter), while the control arm will be treated with intracranial PTA balloon catheter. Subjects enrolled in sub-study A will all be treated with SeQuent®, Please CIS.

All subjects will be followed up till 12 month post procedure.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 80 years old (including boundary value), gender is not limited;
2. 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);
3. 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);
4. 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);
5. The intracranial arterial stenosis lesion to be treated is a single lesion;
6. Patients with at least 1 risk factor for intracranial atherosclerotic plaque, including previous or existing hypertension, hyperlipidemia, diabetes, smoking;
7. Preoperative mRS ≤ 2, and NIHSS≤8;
8. Patients whose life expectancy is greater than 12 months as assessed by the investigator.
9. 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 Criteria:

1. 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;
2. Ischemic symptoms are only associated with branch events;
3. Severe stenosis or occlusion of tandem extracranial or intracranial vessels at the proximal or distal end of the target vessel;
4. Angioplasty or stenting procedures is planned for extracranial vascular lesions with tandem intracranial vessels;
5. History of endarterectomy in the extracranial segment of carotid artery and vertebral artery within 30 days;
6. The target vessel has previously been treated with stenting or angioplasty or other mechanical devices (for Part A only);
7. Acute or subacute intraluminal thrombosis is found in the target vessel;
8. Patients with intracranial stenosis combined with aneurysm, intracranial tumor or intracranial vascular malformation, or intracranial arterial spasm without significant stenosis;
9. Intracranial hemorrhage (cerebral intraparenchymal hemorrhage, massive subarachnoid hemorrhage, and subdural/epidural hemorrhage) within 3 months;
10. There are cardiogenic stroke or risk factors that may contribute to cardioembolism, such as fibrillation, left ventricular thrombosis or myocardial infarction within 6 weeks,;
11. Patients with abnormal coagulation function or bleeding tendency (e.g., international normalized ratio (INR) \> 1.5);
12. Patients with known hypersensitivity to iodine contrast medium, paclitaxel, or iopromide;
13. Patients who are participating in clinical trials of other drugs or devices;
14. Other conditions that the investigator deems the patient unsuitable for enrollment.

Primary outcomes:
measure: restenosis incidence of target lesion
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Device success rate
timeFrame: baseline procedure
measure: The changes of Modified Rankin Scale(mRS) score
timeFrame: 6 and 12 months post-procedure
measure: The changes of NIH Stroke Scale(NIHSS) score
timeFrame: 6 and 12 months post-procedure
measure: Number and incidence (%) of target vessel stroke events (including ischemic or hemorrhagic stroke), transient ischemic attack
timeFrame: 6 and 12 months post-procedure
measure: Recurrence incidence of ipsilateral ischemic stroke
timeFrame: 30 days, 6 and 12 months post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Jining
country: China
facility: Jining First People's Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University, School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liqun Jiao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xuanwu Hospital, Beijing
name: Yan Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: