First-in-man Trial Evaluating the Safety and Efficacy of the NOVA Intracranial Stent (NOVA Trial)

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.

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

• >70% intracranial large-vessel stenosis beyond the responsible vessel;
• >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;
• Acute ischemic stroke within 3 weeks;
• Obstruction of perforating branch artery under the skull MRI;
• Intracranial hemorrhage in the angiopathic area within 6 weeks;
• Patient was treated by thrombolytic therapy within 24 hours;
• Patients underwent surgery within 30 days or plan for surgery within 3 months post-stenting procedure;
• Severe calcified lesions;
• Patients have been treated by intracranial/extracranial stenting procedures prior to this study;
• Nonatherosclerosis lesions;
• Patients with potential sources for cardiac embolism;
• Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;
• 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);
• Hemoglobin <100g/L, platelet count <100,000 cells/mm3, International normalized ratio (INR) >1.5 (irreversible) or uncorrectable hemorrhagic factors;
• Serious neural dysfunction due to the responsible angiopathy as the sequel of cerebral infarction (mRS≥3);
• Known liver or renal insufficiency (ALT> 3x upper limit or AST > 3x upper limit, creatinine > 1.5x upper limit);
• Life expectancy < 2 years;
• Pregnant/lactating female patients;
• Patients with cognitive impairment or mental diseases;
• The patient participated in another investigational device or drug study within 3 months;
• Inapplicable for intravascular stenting treatment as per investigators judgment.