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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
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Prospective, multi-center, randomized 1:1 single blind trial using NOVA sirolimus eluting stent versus Apollo bare metal stent conducted in approximately 15 interventional neurology centers in China. The study was sponsored by Sino Medical Sciences Technology Inc.
The study will enroll 264 subjects overall in two groups (randomized 1:1). The study follow-up will occur at 1, 6 and 12 months post-stent implantation. All patients will undergo angiography assessment (DSA/CTA) at 12 months follow-up. Angiography assessment will be performed at baseline (pre- and post-procedure) and 12 months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | NOVA Intracranial sirolimus eluting stent system |
|
| Control | Active Comparator | Apollo Intracranial stent system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOVA Intracranial Sirolimus Eluting Stent System | Device | A sirolimus eluting intracranial stent system with polylactic-co-glycolic acid (PLGA) biodegradable drug carrier and electro-grated polybutyl methacrylate (PBMA) base coating. The stent platform is made of 316L stainless steel. |
| Measure | Description | Time Frame |
|---|---|---|
| In stent restenosis rate (> 50% restenosis) | Angiography assessment at 12 months post-procedure | 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke and death events | within 30 days after stenting | |
| Target vessel ischemic stroke event | between 30 days and 1 year post-procedure | |
| Acute procedural success rate (stenosis < 30%) |
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Inclusion Criteria:
18 to 75 years of age;
Primary or recurrent symptomatic intracranial arteriostenosis through the internal medicine treatment (i.e. stroke or transient ischemic attack within 90 days during the treatment with at least one anti-thrombotic drugs and vascular risk factor intervention e.g. hypertensors for hypertension and hypolipidemics for hyperlipidemia);
No transient ischemic attack (TIA) or ischemic stroke occurred within 2 weeks prior to stenting procedure;
≥70% stenosis of intracranial responsible vessel under the DSA angiography (as judged through the WASID method);
Poor blood circulation in the side branch of responsible vessel area under the angiography within one week prior to stenting procedure:
Score of blood circulation in the side branch under the DSA <3 or blood flow rate peak ≥200cm/s at the systolic phase under the transcranial doppler ultrasonic examination (TCD); or no apparent side branch compensation in the responsible vessel area under CTA or score of blood circulation in the side branch under the CTA <2;
The target lesion reference diameter must be visually estimated to be ≥2.0 mm in diameter, and lesion length must be <15 mm; no lesion observed in the distal vessel;
Atherosclerosis lesions;
mRS < 3;
Written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhongrong Miao, M.D. | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34982098 | Derived | Jia B, Zhang X, Ma N, Mo D, Gao F, Sun X, Song L, Liu L, Deng Y, Xu X, Zhang Y, Liu Z, Guan S, Zhang F, Li B, Zheng H, Liu X, Liu Y, Chen K, Shuai J, Wan J, Wang J, Shi X, Li T, Chang B, Liebeskind DS, Yu W, Miao Z; NOVA Trial Investigators. Comparison of Drug-Eluting Stent With Bare-Metal Stent in Patients With Symptomatic High-grade Intracranial Atherosclerotic Stenosis: A Randomized Clinical Trial. JAMA Neurol. 2022 Feb 1;79(2):176-184. doi: 10.1001/jamaneurol.2021.4804. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Apollo Intracranial Stent System | Device | A 316L stainless steel balloon-expandable intracranial stent system |
|
| 1 year |
| Target vessel stroke or death events | within 30 days after stenting |
| Non-target vessels ischemic stroke event | between 30 days and 1 year post-procedure |
| Recurrent ischemic stroke in the involved vascular area | between 30 days and 1 year post-procedure |
| Cerebral parenchyma hemorrhage, subarachnoid hemorrhage and intraventricular bleeding events | between 30 days and 1 year post-procedure |
| Death event | between 30 days and 1 year post-procedure |
| Transient ischemic attack event | within 1 year post-procedure |
| National Institutes of Health Stroke Scale (NIHSS) evaluation | at 1 and 12 months |
| modulate RANK score (mRS)evaluation | at 1 and 12 months |
| Montreal Cognitive Assessment (MoCA) evaluation | at 1 and 12 months |
| EQ-5D score evaluation | at 12 months |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |