Clinical trial NCT05719883: Evaluating the Safety and Efficacy of the Maurora® DES in 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intracranial Arteriosclerosis
Stroke (CVA) or TIA
Keywords: Intracranial Atherosclerotic stenosis
Drug-eluting stent
Ischemia stroke
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Alain Medical (Beijing) Co., Ltd.
First posted: 2023-02-09
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age from 18 to 85 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.

Primary outcomes:
measure: In-stent restenosis rate(ISR) within 12 months after procedure
timeFrame: 12 months after procedure
Secondary outcomes:
measure: Implantation success rate
timeFrame: During the procedure
measure: Technical success rate
timeFrame: During the procedure
measure: Clinical success rate
timeFrame: 12 months after procedure
measure: Stroke or death within 30 days after procedure
timeFrame: within 30 days after procedure
measure: Stroke in the target vessel territory or death within 30 days after procedure
timeFrame: within 30 days after procedure
measure: Ischemic stroke in the target vessel territory between 31 day to 1 year after procedure
timeFrame: between 31 day to 1 year after procedure
measure: Ischemic stroke in other vessel territory between 31 day to 1 year after procedure
timeFrame: between 31 day to 1 year after procedure
measure: Any ischemic stroke between 31 day to 1 year after procedure
timeFrame: between 31 day to 1 year after procedure
measure: Any subdural, epidural hemorrhage or a systemic hemorrhage between 31 day to 1 year after procedure
timeFrame: between 31 day to 1 year after procedure
measure: Death between 31 day to 1 year after procedure
timeFrame: between 31 day to 1 year after procedure
measure: Transient Ischemic Attack within 1 year after the procedure
timeFrame: 1 year after the procedure
measure: Functional outcome measured by the modified Rankin Scale
timeFrame: 1 and 12 months after procedure
Other outcomes:
measure: Complications of stent implantation procedure
timeFrame: 12 months after procedure
measure: Stroke
timeFrame: 12 months after procedure
measure: adverse events (AE) and serious adverse events (SAE)
timeFrame: 12 months after procedure
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ning Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
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