First-in-man Trial Evaluating the Safety and Efficacy of the NOVA Intracranial Stent (NOVA Trial)
NCT ID: NCT02578069
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
272 participants
INTERVENTIONAL
2015-04-27
2020-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental
NOVA Intracranial sirolimus eluting stent system
NOVA 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.
Control
Apollo Intracranial stent system
Apollo Intracranial Stent System
A 316L stainless steel balloon-expandable intracranial stent system
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NOVA 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.
Apollo Intracranial Stent System
A 316L stainless steel balloon-expandable intracranial stent system
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Tiantan Hospital
OTHER
Sino Medical Sciences Technology Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhongrong Miao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Tiantan Hospital
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NOVA-001
Identifier Type: -
Identifier Source: org_study_id