Paclitaxel Drug-eluting Balloon Catheters in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis and Restenosis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Intracranial Atherosclerotic Stenosis
• Intervention / Treatment: Device: DCB; Device: POBA

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.

• Study Type: Interventional
• Enrollment (Estimated): 277
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iris Zhang; Phone Number: ＋86 10 5763 2775; Email: Iris.zhang@bbraun.com
• Study Contact Backup: Name: Jason Yan; Phone Number: +86 21 22163026; Email: jason.yan@bbraun.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Yan Ma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: De-novo DCB group; Patients with de-novo symptomatic intracranial atherosclerotic stenosis and treated with DCB	Device: DCB; Intracranial paclitaxel drug-eluting balloon catheters (SeQuent® Please CIS)
Active Comparator: De-novo POBA group; Patients with de-novo symptomatic intracranial atherosclerotic stenosis and treated with POBA	Device: POBA; Intracranial PTA balloon catheter
Experimental: Restenosis group; Patients with symptomatic intracranial atherosclerotic re-stenosis after interventional therapy and treated with DCB	Device: DCB; Intracranial paclitaxel drug-eluting balloon catheters (SeQuent® Please CIS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
restenosis incidence of target lesion	angiographic restenosis measured by WASID ( Warfarin-Aspirin Symptomatic Intracranial Disease) method in core-lab	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device success rate	Successful delivery, dilatation and withdraw of the balloon	baseline procedure
The changes of Modified Rankin Scale(mRS) score	Scores range from 0 to 6, with higher scores indicating more severe nerve damage; Change of mRS score = mRS score at 6 months (12 months) after surgery - mRS score at baseline	6 and 12 months post-procedure
The changes of NIH Stroke Scale(NIHSS) score	Scores range from 0 to 42, with higher scores indicating more severe nerve damage; Change of NIHSS score = NIHSS score at 6 months (12 months) after surgery - NIHSS score at baseline.	6 and 12 months post-procedure
Number and incidence (%) of target vessel stroke events (including ischemic or hemorrhagic stroke), transient ischemic attack	Incidence of target vessel stroke events (%) = (number of subjects with target vessel stroke events/total number of subjects) × 100%. Incidence of transient ischemic attacks (%) = (number of subjects with transient ischemic attacks/total number of subjects) × 100%.	6 and 12 months post-procedure
Recurrence incidence of ipsilateral ischemic stroke	Recurrence incidence of ipsilateral ischemic stroke (%) = (number of subjects with recurrent ipsilateral ischemic stroke/total number of subjects) × 100%.	30 days, 6 and 12 months post-procedure

Collaborators and Investigators

• Sponsor: B. Braun Medical International Trading Company Ltd.
• Investigators: Principal Investigator: Liqun Jiao, MD, Xuanwu Hospital, Beijing; Principal Investigator: Yan Ma, MD, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): July 23, 2024
• Study Completion (Estimated): January 23, 2025

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: DCB; symptomatic intracranial atherosclerotic stenosis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: SPINAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No