SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis

Last updated: October 18, 2024
Sponsor: B. Braun Medical International Trading Company Ltd.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

POBA

DCB

Clinical Study ID

NCT06047964
SPINAS
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 atheroscleroticstenosis lesion (for part A only) or restenosis lesions after interventional therapy (for part B only);

  3. Symptomatic intracranial arterial stenosis (intracranial segment of internal carotidartery (Petrous segment and above), middle cerebral artery, intracranial segment ofvertebral artery, basilar artery, etc.) within 6 months, the degree of stenosis ofthe diseased artery is between 70% and 99% (WASID method);

  4. Patients with symptoms occurring more than once (symptoms refer to stroke ortransient ischemic attacks) after intensive drug therapy of internal medicine (including antiplatelet therapy, antihypertensive therapy, hypoglycemic therapy andlipid-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 theinvestigator.

  9. Patients or their guardians can understand the trial purpose, voluntarilyparticipate in and sign the informed consent form, and can accept follow-up visits.

Exclusion

Exclusion Criteria:

  1. Severe calcification in the target vessel, severe distortion of the target vessel oranatomical 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 theproximal or distal end of the target vessel;

  4. Angioplasty or stenting procedures is planned for extracranial vascular lesions withtandem intracranial vessels;

  5. History of endarterectomy in the extracranial segment of carotid artery andvertebral artery within 30 days;

  6. The target vessel has previously been treated with stenting or angioplasty or othermechanical 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 orintracranial vascular malformation, or intracranial arterial spasm withoutsignificant stenosis;

  9. Intracranial hemorrhage (cerebral intraparenchymal hemorrhage, massive subarachnoidhemorrhage, 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 6weeks,;

  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, oriopromide;

  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.

Study Design

Total Participants: 281
Treatment Group(s): 2
Primary Treatment: POBA
Phase:
Study Start date:
March 23, 2023
Estimated Completion Date:
January 23, 2025

Study 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.

Connect with a study center

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing 100000
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • Jining First People's Hospital

    Jining, Shandong
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiaotong University, School of Medicine

    Shanghai, Shanghai
    China

    Site Not Available

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

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