Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-04 @ 12:11 AM
Study NCT ID:
NCT02578069
Status:
COMPLETED
Last Update Posted:
2021-10-13
First Post:
2015-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-in-man Trial Evaluating the Safety and Efficacy of the NOVA Intracranial Stent (NOVA Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-10-14', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In stent restenosis rate (> 50% restenosis)', 'timeFrame': '12 months post-procedure', 'description': 'Angiography assessment at 12 months post-procedure'}], 'secondaryOutcomes': [{'measure': 'Stroke and death events', 'timeFrame': 'within 30 days after stenting'}, {'measure': 'Target vessel ischemic stroke event', 'timeFrame': 'between 30 days and 1 year post-procedure'}, {'measure': 'Acute procedural success rate (stenosis < 30%)', 'timeFrame': '1 year'}, {'measure': 'Target vessel stroke or death events', 'timeFrame': 'within 30 days after stenting'}, {'measure': 'Non-target vessels ischemic stroke event', 'timeFrame': 'between 30 days and 1 year post-procedure'}, {'measure': 'Recurrent ischemic stroke in the involved vascular area', 'timeFrame': 'between 30 days and 1 year post-procedure'}, {'measure': 'Cerebral parenchyma hemorrhage, subarachnoid hemorrhage and intraventricular bleeding events', 'timeFrame': 'between 30 days and 1 year post-procedure'}, {'measure': 'Death event', 'timeFrame': 'between 30 days and 1 year post-procedure'}, {'measure': 'Transient ischemic attack event', 'timeFrame': 'within 1 year post-procedure'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS) evaluation', 'timeFrame': 'at 1 and 12 months'}, {'measure': 'modulate RANK score （mRS）evaluation', 'timeFrame': 'at 1 and 12 months'}, {'measure': 'Montreal Cognitive Assessment (MoCA) evaluation', 'timeFrame': 'at 1 and 12 months'}, {'measure': 'EQ-5D score evaluation', 'timeFrame': 'at 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ischemic Stroke', 'Intracranial Stenting'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '34982098', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 to 75 years of age;\n2. 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);\n3. No transient ischemic attack (TIA) or ischemic stroke occurred within 2 weeks prior to stenting procedure;\n4. ≥70% stenosis of intracranial responsible vessel under the DSA angiography (as judged through the WASID method);\n5. Poor blood circulation in the side branch of responsible vessel area under the angiography within one week prior to stenting procedure:\n\n 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;\n6. 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;\n7. Atherosclerosis lesions;\n8. mRS \\< 3;\n9. Written informed consent.\n\nExclusion Criteria:\n\n1. \\>70% intracranial large-vessel stenosis beyond the responsible vessel;\n2. \\>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;\n3. Acute ischemic stroke within 3 weeks;\n4. Obstruction of perforating branch artery under the skull MRI;\n5. Intracranial hemorrhage in the angiopathic area within 6 weeks;\n6. Patient was treated by thrombolytic therapy within 24 hours;\n7. Patients underwent surgery within 30 days or plan for surgery within 3 months post-stenting procedure;\n8. Severe calcified lesions;\n9. Patients have been treated by intracranial/extracranial stenting procedures prior to this study;\n10. Nonatherosclerosis lesions;\n11. Patients with potential sources for cardiac embolism;\n12. Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;\n13. 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);\n14. Hemoglobin \\<100g/L, platelet count \\<100,000 cells/mm3, International normalized ratio (INR) \\>1.5 (irreversible) or uncorrectable hemorrhagic factors;\n15. Serious neural dysfunction due to the responsible angiopathy as the sequel of cerebral infarction (mRS≥3);\n16. Known liver or renal insufficiency (ALT\\> 3x upper limit or AST \\> 3x upper limit, creatinine \\> 1.5x upper limit);\n17. Life expectancy \\< 2 years;\n18. Pregnant/lactating female patients;\n19. Patients with cognitive impairment or mental diseases;\n20. The patient participated in another investigational device or drug study within 3 months;\n21. Inapplicable for intravascular stenting treatment as per investigators judgment.'}, 'identificationModule': {'nctId': 'NCT02578069', 'acronym': 'NOVA', 'briefTitle': 'First-in-man Trial Evaluating the Safety and Efficacy of the NOVA Intracranial Stent (NOVA Trial)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sino Medical Sciences Technology Inc.'}, 'officialTitle': 'A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of the NOVA Sirolimus Eluting Stent Versus the Apollo Stent', 'orgStudyIdInfo': {'id': 'NOVA-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'NOVA Intracranial sirolimus eluting stent system', 'interventionNames': ['Device: NOVA Intracranial Sirolimus Eluting Stent System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Apollo Intracranial stent system', 'interventionNames': ['Device: Apollo Intracranial Stent System']}], 'interventions': [{'name': 'NOVA Intracranial Sirolimus Eluting Stent System', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Experimental']}, {'name': 'Apollo Intracranial Stent System', 'type': 'DEVICE', 'description': 'A 316L stainless steel balloon-expandable intracranial stent system', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Zhongrong Miao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sino Medical Sciences Technology Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}