Ischemic Stroke
Conditions
Keywords
Ischemic Stroke, Intracranial Stenting
Brief summary
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.
Detailed description
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.
Interventions
DEVICENOVA Intracranial Sirolimus Eluting Stent System
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.
DEVICEApollo Intracranial Stent System
A 316L stainless steel balloon-expandable intracranial stent system
Sponsors
Beijing Tiantan Hospital
Sino Medical Sciences Technology Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 75 years of age; 2. 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); 3. No transient ischemic attack (TIA) or ischemic stroke occurred within 2 weeks prior to stenting procedure; 4. ≥70% stenosis of intracranial responsible vessel under the DSA angiography (as judged through the WASID method); 5. 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; 6. 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; 7. Atherosclerosis lesions; 8. mRS \< 3; 9. Written informed consent.
Exclusion criteria
1. \>70% intracranial large-vessel stenosis beyond the responsible vessel; 2. \>70% stenosis observed at the intracranial large-vessel distal to the responsible vessel or \>70% stenosis observed at the intracranial/extracranial large-vessel proximal to the responsible vessel; 3. Acute ischemic stroke within 3 weeks; 4. Obstruction of perforating branch artery under the skull MRI; 5. Intracranial hemorrhage in the angiopathic area within 6 weeks; 6. Patient was treated by thrombolytic therapy within 24 hours; 7. Patients underwent surgery within 30 days or plan for surgery within 3 months post-stenting procedure; 8. Severe calcified lesions; 9. Patients have been treated by intracranial/extracranial stenting procedures prior to this study; 10. Nonatherosclerosis lesions; 11. Patients with potential sources for cardiac embolism; 12. Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation; 13. Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study, sirolimus, poly(lactic-co-glycolic acid) polymers, or poly(n-butyl methacrylate); 14. Hemoglobin \<100g/L, platelet count \<100,000 cells/mm3, International normalized ratio (INR) \>1.5 (irreversible) or uncorrectable hemorrhagic factors; 15. Serious neural dysfunction due to the responsible angiopathy as the sequel of cerebral infarction (mRS≥3); 16. Known liver or renal insufficiency (ALT\> 3x upper limit or AST \> 3x upper limit, creatinine \> 1.5x upper limit); 17. Life expectancy \< 2 years; 18. Pregnant/lactating female patients; 19. Patients with cognitive impairment or mental diseases; 20. The patient participated in another investigational device or drug study within 3 months; 21. Inapplicable for intravascular stenting treatment as per investigators judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In stent restenosis rate (> 50% restenosis) | 12 months post-procedure | Angiography assessment at 12 months post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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%) | 1 year |
| Cerebral parenchyma hemorrhage, subarachnoid hemorrhage and intraventricular bleeding events | between 30 days and 1 year post-procedure |
| Recurrent ischemic stroke in the involved vascular area | 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 |
| Death event | between 30 days and 1 year post-procedure |
Countries
China
Outcome results
None listed