Intracranial Arteriosclerosis, Stroke (CVA) or TIA
Conditions
Keywords
Intracranial Atherosclerotic stenosis, Drug-eluting stent, Ischemia stroke
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.
Interventions
DEVICEMaurora® 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.
DEVICEAPOLLO™ 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.
Sponsors
Alain Medical (Beijing) Co., Ltd.
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent restenosis rate(ISR) within 12 months after procedure | 12 months after procedure | Angiographic evidence of in-stent stenosis ≥50% at 12 months after procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ischemic stroke in the target vessel territory between 31 day to 1 year after procedure | between 31 day to 1 year after procedure | Any ischemic stroke events related to target vessel after revascularization. |
| Death between 31 day to 1 year after procedure | between 31 day to 1 year after procedure | All-cause death. |
| Transient Ischemic Attack within 1 year after the procedure | 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 | 1 and 12 months after procedure | 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. |
| Implantation success rate | During the procedure | Implantation success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system. |
| Technical success rate | During the procedure | 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 | 12 months after procedure | 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 | 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 | within 30 days after procedure | Death or any stroke events related to target vessel after revascularization. |
| Ischemic stroke in other vessel territory between 31 day to 1 year after procedure | 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 | 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 | between 31 day to 1 year after procedure | Any subdural or epidural hemorrhage or a systemic hemorrhage is required hospitalization, blood transfusion, or surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse events (AE) and serious adverse events (SAE) | 12 months after procedure | — |
| Stroke | 12 months after procedure | — |
| Complications of stent implantation procedure | 12 months after procedure | 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. |
Countries
China
Outcome results
None listed