SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis

NCT ID: NCT06047964

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-23
• Study Completion Date: 2025-01-23

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.

Conditions

Stroke; Intracranial Atherosclerotic Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

De-novo DCB group

Patients with de-novo symptomatic intracranial atherosclerotic stenosis and treated with DCB

Group Type: EXPERIMENTAL

DCB

Intervention Type: DEVICE

Intracranial paclitaxel drug-eluting balloon catheters (SeQuent® Please CIS)

De-novo POBA group

Patients with de-novo symptomatic intracranial atherosclerotic stenosis and treated with POBA

Group Type: ACTIVE_COMPARATOR

POBA

Intervention Type: DEVICE

Intracranial PTA balloon catheter

Restenosis group

Patients with symptomatic intracranial atherosclerotic re-stenosis after interventional therapy and treated with DCB

Group Type: EXPERIMENTAL

DCB

Intervention Type: DEVICE

Intracranial paclitaxel drug-eluting balloon catheters (SeQuent® Please CIS)

Interventions

DCB

Intracranial paclitaxel drug-eluting balloon catheters (SeQuent® Please CIS)

Intervention Type: DEVICE

POBA

Intracranial PTA balloon catheter

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Medical International Trading Company Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liqun Jiao, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Yan Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Nanyang Central Hospital

Nanyang, Henan, China

The First Hospital of Jilin University

Changchun, Jilin, China

Jining First People's Hospital

Jining, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Renji Hospital, Shanghai Jiaotong University, School of Medicine

Shanghai, Shanghai Municipality, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

SPINAS

Identifier Type: -

Identifier Source: org_study_id