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Evaluating the Safety and Efficacy of the Maurora® DES in ICAS (Maurora ICAS)

Primary Purpose

Intracranial Arteriosclerosis, Stroke (CVA) or TIA

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Maurora® Sirolimus Eluting Stent System
APOLLO™ Intracranial Stent System
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Arteriosclerosis focused on measuring Intracranial Atherosclerotic stenosis, Drug-eluting stent, Ischemia stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age from 18 to 85 years; Symptomatic intracranial atherosclerosis (Definition: Stroke or transient ischemic attack [TIA] associated with intracranial atherosclerosis within 90 days of enrollment); A major intracranial artery (carotid artery, MCA stem [M1], vertebral artery, or basilar artery) with 70% to 99% stenosis on the angiography (According to WASID method); The target lesion length ≤15 mm and the vessel diameter between 2.5mm and 5.0mm, distal vessel diameter >1.5mm; Only one stent planned for the target lesion; A Modified Rankin Score of ≤ 3; Patients understand the purpose and requirements of the study, and can make him/herself understood, and has provided informed consent. Exclusion Criteria: Ischemic stroke within 2 weeks before the procedure; Tandem extracranial or intracranial stenosis (70%-99%) of the target lesion; Patients with stroke caused by perforating artery occlusion; Severe calcification at target lesion; Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 6 weeks; History of stenting or angioplasty of an intracranial artery; Intracranial tumor, aneurysm or intracranial arteriovenous malformation; Intracranial artery stenosis caused by non-atherosclerotic lesions, including: moya-moya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, post-partum vascular disease, suspected vasospasm, suspicious embolism recanalization; Presence of any unequivocal cardiac source of embolism (e.g. atrial fibrillation); Those who cannot tolerate general anesthesia due to insufficiency of cardiac or pulmonary function, not suitable for procedure; Known allergy or contraindication to heparin, aspirin, ticlopidine, ticagrelor, sirolimus, anaesthetics and contrast agents; Severe renal and hepatic insufficiency (ALTor AST > 3x upper limit, creatinine > 1.5x upper limit); Major surgery within the past 30 days or planned within 90 days, or requiring simultaneous intervention to renal artery, iliac artery, and coronary artery; Life expectancy <12 months; Pregnant or lactating women, or planning for pregnancy; Participated in another investigational device or drug study within 30 days; According to the judgement of the investigator, other situations that are not suitable for enrollment.

Sites / Locations

  • Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Maurora® Sirolimus Eluting Stent System

APOLLO™ Intracranial Stent System

Arm Description

Device: Maurora® Sirolimus Eluting Stent System A sirolimus eluting intracranial stent system with platform is made of L605 CoCr alloys.

Device: Apollo Intracranial Stent System A 316L stainless steel balloon-expandable intracranial stent system.

Outcomes

Primary Outcome Measures

In-stent restenosis rate(ISR) within 12 months after procedure
Angiographic evidence of in-stent stenosis ≥50% at 12 months after procedure

Secondary Outcome Measures

Implantation success rate
Implantation success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system.
Technical success rate
Technical success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system with a residual stenosis of <30%.
Clinical success rate
Clinical success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system with a residual stenosis of <30%, and free from major adverse event within 12 months after procedure. system with a residual stenosis of <30%
Stroke or death within 30 days after procedure
Any stroke included ischemic stroke or/and symptomatic brain hemorrhage and all-cause death.
Stroke in the target vessel territory or death within 30 days after procedure
Death or any stroke events related to target vessel after revascularization.
Ischemic stroke in the target vessel territory between 31 day to 1 year after procedure
Any ischemic stroke events related to target vessel after revascularization.
Ischemic stroke in other vessel territory between 31 day to 1 year after procedure
Any ischemic stroke events unrelated to target vessel after revascularization.Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery.
Any ischemic stroke between 31 day to 1 year after procedure
Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery.
Any subdural, epidural hemorrhage or a systemic hemorrhage between 31 day to 1 year after procedure
Any subdural or epidural hemorrhage or a systemic hemorrhage is required hospitalization, blood transfusion, or surgery.
Death between 31 day to 1 year after procedure
All-cause death.
Transient Ischemic Attack within 1 year after the procedure
A transient ischemic attack (TIA) is a temporary period of symptoms similar to those of a stroke. A TIA usually lasts only a few minutes up to 24 hours and doesn't cause permanent damage.
Functional outcome measured by the modified Rankin Scale
Focus on difference between 1 month and 12 months after procedure. The range of modified Rankin Scale was from 0 to 6. 0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6 -Dead. A higher score indicates worse a outcome.

Full Information

First Posted
January 31, 2023
Last Updated
September 19, 2023
Sponsor
Beijing Tiantan Hospital
Collaborators
Alain Medical (Beijing) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05719883
Brief Title
Evaluating the Safety and Efficacy of the Maurora® DES in ICAS
Acronym
Maurora ICAS
Official Title
A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of the Maurora® Sirolimus-Eluting Stent Versus the Apollo Stent in Intracranial Atherosclerotic Stenosis(Maurora ICAS Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Alain Medical (Beijing) Co., 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
The purpose of the RCT trial is to evaluate whether implantation of drug-eluting stent (DES) is more efficacious than bare metal stent (BMS) in prevention of in-stent restenosis (ISR) and improvement of outcomes for symptomatic intracranial atherosclerotic stenosis. This trial is prospective, multi-center, randomized 1:1 single blind trial using Maurora sirolimus eluting stent versus Apollo bare metal stent conducted in approximately 10 interventional neurology centers in China. The study is sponsored by Alain Medical (Beijing) Co., Ltd.
Detailed Description
This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent versus bare metal stent (BMS) to treat intracranial stenosis of 70-99% degree. The primary endpoint is in-stent restenosis rate(ISR) within 12 months after revascularization procedure of the qualifying lesion during follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arteriosclerosis, Stroke (CVA) or TIA
Keywords
Intracranial Atherosclerotic stenosis, Drug-eluting stent, Ischemia stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maurora® Sirolimus Eluting Stent System
Arm Type
Experimental
Arm Description
Device: Maurora® Sirolimus Eluting Stent System A sirolimus eluting intracranial stent system with platform is made of L605 CoCr alloys.
Arm Title
APOLLO™ Intracranial Stent System
Arm Type
Active Comparator
Arm Description
Device: Apollo Intracranial Stent System A 316L stainless steel balloon-expandable intracranial stent system.
Intervention Type
Device
Intervention Name(s)
Maurora® Sirolimus Eluting Stent System
Other Intervention Name(s)
Maurora
Intervention Description
The Maurora® for intracranial PTA treatment comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.
Intervention Type
Device
Intervention Name(s)
APOLLO™ Intracranial Stent System
Other Intervention Name(s)
APOLLO
Intervention Description
The Apollo stent system comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.
Primary Outcome Measure Information:
Title
In-stent restenosis rate(ISR) within 12 months after procedure
Description
Angiographic evidence of in-stent stenosis ≥50% at 12 months after procedure
Time Frame
12 months after procedure
Secondary Outcome Measure Information:
Title
Implantation success rate
Description
Implantation success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system.
Time Frame
During the procedure
Title
Technical success rate
Description
Technical success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system with a residual stenosis of <30%.
Time Frame
During the procedure
Title
Clinical success rate
Description
Clinical success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system with a residual stenosis of <30%, and free from major adverse event within 12 months after procedure. system with a residual stenosis of <30%
Time Frame
12 months after procedure
Title
Stroke or death within 30 days after procedure
Description
Any stroke included ischemic stroke or/and symptomatic brain hemorrhage and all-cause death.
Time Frame
within 30 days after procedure
Title
Stroke in the target vessel territory or death within 30 days after procedure
Description
Death or any stroke events related to target vessel after revascularization.
Time Frame
within 30 days after procedure
Title
Ischemic stroke in the target vessel territory between 31 day to 1 year after procedure
Description
Any ischemic stroke events related to target vessel after revascularization.
Time Frame
between 31 day to 1 year after procedure
Title
Ischemic stroke in other vessel territory between 31 day to 1 year after procedure
Description
Any ischemic stroke events unrelated to target vessel after revascularization.Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery.
Time Frame
between 31 day to 1 year after procedure
Title
Any ischemic stroke between 31 day to 1 year after procedure
Description
Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery.
Time Frame
between 31 day to 1 year after procedure
Title
Any subdural, epidural hemorrhage or a systemic hemorrhage between 31 day to 1 year after procedure
Description
Any subdural or epidural hemorrhage or a systemic hemorrhage is required hospitalization, blood transfusion, or surgery.
Time Frame
between 31 day to 1 year after procedure
Title
Death between 31 day to 1 year after procedure
Description
All-cause death.
Time Frame
between 31 day to 1 year after procedure
Title
Transient Ischemic Attack within 1 year after the procedure
Description
A transient ischemic attack (TIA) is a temporary period of symptoms similar to those of a stroke. A TIA usually lasts only a few minutes up to 24 hours and doesn't cause permanent damage.
Time Frame
1 year after the procedure
Title
Functional outcome measured by the modified Rankin Scale
Description
Focus on difference between 1 month and 12 months after procedure. The range of modified Rankin Scale was from 0 to 6. 0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6 -Dead. A higher score indicates worse a outcome.
Time Frame
1 and 12 months after procedure
Other Pre-specified Outcome Measures:
Title
Complications of stent implantation procedure
Description
Any complications including vascular complications of assess the intracranial arteries, Allergic reactions or hypersensitivity to agents or device in procedure, complications of intracranial arteries, infection, fever, bleeding and other events.
Time Frame
12 months after procedure
Title
Stroke
Time Frame
12 months after procedure
Title
adverse events (AE) and serious adverse events (SAE)
Time Frame
12 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 18 to 85 years; Symptomatic intracranial atherosclerosis (Definition: Stroke or transient ischemic attack [TIA] associated with intracranial atherosclerosis within 90 days of enrollment); A major intracranial artery (carotid artery, MCA stem [M1], vertebral artery, or basilar artery) with 70% to 99% stenosis on the angiography (According to WASID method); The target lesion length ≤15 mm and the vessel diameter between 2.5mm and 5.0mm, distal vessel diameter >1.5mm; Only one stent planned for the target lesion; A Modified Rankin Score of ≤ 3; Patients understand the purpose and requirements of the study, and can make him/herself understood, and has provided informed consent. Exclusion Criteria: Ischemic stroke within 2 weeks before the procedure; Tandem extracranial or intracranial stenosis (70%-99%) of the target lesion; Patients with stroke caused by perforating artery occlusion; Severe calcification at target lesion; Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 6 weeks; History of stenting or angioplasty of an intracranial artery; Intracranial tumor, aneurysm or intracranial arteriovenous malformation; Intracranial artery stenosis caused by non-atherosclerotic lesions, including: moya-moya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, post-partum vascular disease, suspected vasospasm, suspicious embolism recanalization; Presence of any unequivocal cardiac source of embolism (e.g. atrial fibrillation); Those who cannot tolerate general anesthesia due to insufficiency of cardiac or pulmonary function, not suitable for procedure; Known allergy or contraindication to heparin, aspirin, ticlopidine, ticagrelor, sirolimus, anaesthetics and contrast agents; Severe renal and hepatic insufficiency (ALTor AST > 3x upper limit, creatinine > 1.5x upper limit); Major surgery within the past 30 days or planned within 90 days, or requiring simultaneous intervention to renal artery, iliac artery, and coronary artery; Life expectancy <12 months; Pregnant or lactating women, or planning for pregnancy; Participated in another investigational device or drug study within 30 days; According to the judgement of the investigator, other situations that are not suitable for enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baixue Jia, MD
Phone
15010125093
Email
beckyberry@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning Ma, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baixue Jia, MD
Phone
15010125093
Email
beckyberry@163.com
First Name & Middle Initial & Last Name & Degree
Ning Ma
First Name & Middle Initial & Last Name & Degree
Baixue Jia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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31248666
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Results Reference
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Evaluating the Safety and Efficacy of the Maurora® DES in ICAS

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