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

NCT02578069 | Completed DMC

• 1 other identifier: NOVA-001
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Ischemic Stroke; Intracranial Stenting

Outcome Measures

Primary Outcomes (1)

• In stent restenosis rate (> 50% restenosis)

  Angiography assessment at 12 months post-procedure

  12 months post-procedure

Secondary Outcomes (13)

• 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

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

NOVA Intracranial sirolimus eluting stent system

Device: NOVA Intracranial Sirolimus Eluting Stent System

Control

ACTIVE COMPARATOR

Apollo Intracranial stent system

Device: Apollo Intracranial Stent System

Interventions

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.

Experimental

Apollo Intracranial Stent System DEVICE

A 316L stainless steel balloon-expandable intracranial stent system

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \>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);

Sponsors & Collaborators

• Sino Medical Sciences Technology Inc.: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100050, China

Location

Related Publications (1)

• 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.

  PMID: 34982098 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhongrong Miao, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 16, 2015
• Study Start: April 27, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: October 13, 2021

Record last verified: 2019-01

Locations

CN (1)