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

Primary Purpose

Stroke, Intracranial Atherosclerotic Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DCB
POBA
Sponsored by
B. Braun Medical International Trading Company Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring symptomatic intracranial atherosclerotic stenosis, DCB

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Xuanwu Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

De-novo DCB group

De-novo POBA group

Restenosis group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Device success rate
Successful delivery, dilatation and withdraw of the balloon
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
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.
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%.
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%.

Full Information

First Posted
August 30, 2023
Last Updated
September 19, 2023
Sponsor
B. Braun Medical International Trading Company Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06047964
Brief Title
Paclitaxel Drug-eluting Balloon Catheters in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis and Restenosis
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
July 23, 2024 (Anticipated)
Study Completion Date
January 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Medical International Trading Company Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Intracranial Atherosclerotic Stenosis
Keywords
symptomatic intracranial atherosclerotic stenosis, DCB

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
277 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
De-novo DCB group
Arm Type
Experimental
Arm Description
Patients with de-novo symptomatic intracranial atherosclerotic stenosis and treated with DCB
Arm Title
De-novo POBA group
Arm Type
Active Comparator
Arm Description
Patients with de-novo symptomatic intracranial atherosclerotic stenosis and treated with POBA
Arm Title
Restenosis group
Arm Type
Experimental
Arm Description
Patients with symptomatic intracranial atherosclerotic re-stenosis after interventional therapy and treated with DCB
Intervention Type
Device
Intervention Name(s)
DCB
Intervention Description
Intracranial paclitaxel drug-eluting balloon catheters (SeQuent® Please CIS)
Intervention Type
Device
Intervention Name(s)
POBA
Intervention Description
Intracranial PTA balloon catheter
Primary Outcome Measure Information:
Title
restenosis incidence of target lesion
Description
angiographic restenosis measured by WASID ( Warfarin-Aspirin Symptomatic Intracranial Disease) method in core-lab
Time Frame
6 months post-procedure
Secondary Outcome Measure Information:
Title
Device success rate
Description
Successful delivery, dilatation and withdraw of the balloon
Time Frame
baseline procedure
Title
The changes of Modified Rankin Scale(mRS) score
Description
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
Time Frame
6 and 12 months post-procedure
Title
The changes of NIH Stroke Scale(NIHSS) score
Description
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.
Time Frame
6 and 12 months post-procedure
Title
Number and incidence (%) of target vessel stroke events (including ischemic or hemorrhagic stroke), transient ischemic attack
Description
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%.
Time Frame
6 and 12 months post-procedure
Title
Recurrence incidence of ipsilateral ischemic stroke
Description
Recurrence incidence of ipsilateral ischemic stroke (%) = (number of subjects with recurrent ipsilateral ischemic stroke/total number of subjects) × 100%.
Time Frame
30 days, 6 and 12 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Zhang
Phone
+86 10 5763 2775
Email
Iris.zhang@bbraun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Yan
Phone
+86 21 22163026
Email
jason.yan@bbraun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liqun Jiao, MD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yan Ma, MD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Ma, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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