Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alain Medical (Beijing) Co., Ltd. | UNKNOWN |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maurora® Sirolimus Eluting Stent System | Experimental | Device: Maurora® Sirolimus Eluting Stent System A sirolimus eluting intracranial stent system with platform is made of L605 CoCr alloys. |
|
| APOLLO™ Intracranial Stent System | Active Comparator | Device: Apollo Intracranial Stent System A 316L stainless steel balloon-expandable intracranial stent system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maurora® Sirolimus Eluting Stent System | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent restenosis rate(ISR) within 12 months after procedure | Angiographic evidence of in-stent stenosis ≥50% at 12 months after procedure | 12 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Implantation success rate | Implantation success was defined as successful arrival of stent to the lesion and subsequent release of the stent delivery system. | During the procedure |
| Technical success rate |
| Measure | Description | Time Frame |
|---|---|---|
| Complications of stent implantation 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. | 12 months after procedure |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ning Ma, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31248666 | Background | Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24. | |
| 30871944 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| APOLLO™ Intracranial Stent System | 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. |
|
|
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%.
| During the procedure |
| 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% | 12 months after procedure |
| Stroke or death within 30 days after procedure | Any stroke included ischemic stroke or/and symptomatic brain hemorrhage and all-cause death. | within 30 days after procedure |
| Stroke in the target vessel territory or death within 30 days after procedure | Death or any stroke events related to target vessel after revascularization. | within 30 days after procedure |
| 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. | between 31 day to 1 year after procedure |
| 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. | between 31 day to 1 year after procedure |
| 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. | between 31 day to 1 year after procedure |
| 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. | between 31 day to 1 year after procedure |
| Death between 31 day to 1 year after procedure | All-cause death. | between 31 day to 1 year after procedure |
| 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. | 1 year after the procedure |
| 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. | 1 and 12 months after procedure |
| Stroke |
| 12 months after procedure |
| adverse events (AE) and serious adverse events (SAE) | 12 months after procedure |
| Background |
| GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11. |
| 15800226 | Background | Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033. |
| 21899409 | Background | Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7. |
| 23277374 | Background | Shin YS, Kim BM, Suh SH, Jeon P, Kim DJ, Kim DI, Kim BS, Kim KH, Heo JH, Nam HS, Kim YD. Wingspan stenting for intracranial atherosclerotic stenosis: clinical outcomes and risk factors for in-stent restenosis. Neurosurgery. 2013 Apr;72(4):596-604; discussion 604. doi: 10.1227/NEU.0b013e3182846e09. |
| 23963335 | Background | Jin M, Fu X, Wei Y, Du B, Xu XT, Jiang WJ. Higher risk of recurrent ischemic events in patients with intracranial in-stent restenosis. Stroke. 2013 Nov;44(11):2990-4. doi: 10.1161/STROKEAHA.113.001824. Epub 2013 Aug 20. |
| 42309809 | Derived | Yu Y, Wang X, Zhu L, Dai C, Deng W, Zhang Y, Han JT, Han J, Wei L, Tu J, Yang X, Wan J, Yin C, Shi H, Yuan J, Wang L, Chen C, Fu W, Jia B, Hou Z, Lou X, Miao Z, Wang Y, Li T, Ma N. Durable fluoropolymer drug-eluting stent versus bare-metal stent for the prevention of intracranial in-stent restenosis. J Neurol Neurosurg Psychiatry. 2026 Jun 17:jnnp-2026-338887. doi: 10.1136/jnnp-2026-338887. Online ahead of print. |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |