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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2025-05-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intracranial Arteriosclerosis Stroke (CVA) or TIA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Maurora® Sirolimus Eluting Stent System

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

Group Type EXPERIMENTAL

Maurora® Sirolimus Eluting Stent System

Intervention Type DEVICE

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.

APOLLO™ Intracranial Stent System

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

Group Type ACTIVE_COMPARATOR

APOLLO™ Intracranial Stent System

Intervention Type DEVICE

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.

Interventions

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Maurora® Sirolimus Eluting Stent System

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

APOLLO™ Intracranial Stent System

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.

Intervention Type DEVICE

Other Intervention Names

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Maurora APOLLO

Eligibility Criteria

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Inclusion Criteria

1. Age from 18 to 80 years;
2. Symptomatic intracranial atherosclerosis (Definition: Stroke or transient ischemic attack \[TIA\] associated with intracranial atherosclerosis within 90 days of enrollment);
3. 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);
4. The target lesion length ≤15 mm and the vessel diameter between 2.5mm and 5.0mm, distal vessel diameter \>1.5mm;
5. Only one stent planned for the target lesion;
6. A Modified Rankin Score of ≤ 3;
7. Patients understand the purpose and requirements of the study, and can make him/herself understood, and has provided informed consent.

Exclusion Criteria

1. Ischemic stroke within 2 weeks before the procedure;
2. Tandem extracranial or intracranial stenosis (70%-99%) of the target lesion;
3. Patients with stroke caused by perforating artery occlusion;
4. Severe calcification at target lesion;
5. Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 6 weeks;
6. History of stenting or angioplasty of an intracranial artery;
7. Intracranial tumor, aneurysm or intracranial arteriovenous malformation;
8. 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;
9. Presence of any unequivocal cardiac source of embolism (e.g. atrial fibrillation);
10. Those who cannot tolerate general anesthesia due to insufficiency of cardiac or pulmonary function, not suitable for procedure;
11. Known allergy or contraindication to heparin, aspirin, ticlopidine, ticagrelor, sirolimus, anaesthetics and contrast agents;
12. Severe renal and hepatic insufficiency (ALTor AST \> 3x upper limit, creatinine \> 1.5x upper limit);
13. Major surgery within the past 30 days or planned within 90 days, or requiring simultaneous intervention to renal artery, iliac artery, and coronary artery;
14. Life expectancy \<12 months;
15. Pregnant or lactating women, or planning for pregnancy;
16. Participated in another investigational device or drug study within 30 days;
17. According to the judgement of the investigator, other situations that are not suitable for enrollment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No