SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis

NCT06047964 | Active Not Recruiting

• 1 other identifier: SPINAS
• Study Type: interventional
• Target: 281
• Locations: 1 country
• Sites: 9

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.

Conditions

Stroke; Intracranial Atherosclerotic Stenosis

Keywords

symptomatic intracranial atherosclerotic stenosis; DCB

Outcome Measures

Primary Outcomes (1)

• restenosis incidence of target lesion

  angiographic restenosis measured by WASID ( Warfarin-Aspirin Symptomatic Intracranial Disease) method in core-lab

  6 months post-procedure

Secondary Outcomes (5)

• Device success rate

  baseline procedure

• The changes of Modified Rankin Scale(mRS) score

  6 and 12 months post-procedure

• The changes of NIH Stroke Scale(NIHSS) score

  6 and 12 months post-procedure

• Number and incidence (%) of target vessel stroke events (including ischemic or hemorrhagic stroke), transient ischemic attack

  6 and 12 months post-procedure

• Recurrence incidence of ipsilateral ischemic stroke

  30 days, 6 and 12 months post-procedure

Study Arms (3)

De-novo DCB group

EXPERIMENTAL

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

Device: DCB

De-novo POBA group

ACTIVE COMPARATOR

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

Device: POBA

Restenosis group

EXPERIMENTAL

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

Device: DCB

Interventions

DCB DEVICE

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

De-novo DCB group; Restenosis group

POBA DEVICE

Intracranial PTA balloon catheter

De-novo POBA group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• B. Braun Medical International Trading Company Ltd.: lead

Study Sites (9)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Nanyang Central Hospital

Nanyang, Henan, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

Jining First People's Hospital

Jining, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Renji Hospital, Shanghai Jiaotong University, School of Medicine

Shanghai, Shanghai Municipality, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Liqun Jiao, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

• Yan Ma, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 21, 2023
• Study Start: March 23, 2023
• Primary Completion: September 29, 2024
• Study Completion: January 23, 2025
• Last Updated: October 21, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)