Ischemic StrokeNOVANCT02578069
First-in-man Trial Evaluating the Safety and Efficacy of the NOVA Intracranial Stent (NOVA Trial)
A study testing NOVA Intracranial Sirolimus Eluting Stent System and Apollo Intracranial Stent System in people with Ischemic Stroke, run by Sino Medical Sciences Technology Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- NOVA Intracranial Sirolimus Eluting Stent System and Apollo Intracranial Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2015to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- >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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of the NOVA Sirolimus Eluting Stent Versus the Apollo Stent
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- NOVA Intracranial Sirolimus Eluting Stent System, Apollo Intracranial Stent System
- Keywords
- Ischemic Stroke, Intracranial Stenting
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVA Intracranial Sirolimus Eluting Stent SystemDevice
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 SystemDevice
A 316L stainless steel balloon-expandable intracranial stent system
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | NOVA Intracranial sirolimus eluting stent system Receives: Device: NOVA Intracranial Sirolimus Eluting Stent System |
| Control | Active comparator | Apollo Intracranial stent system Receives: Device: Apollo Intracranial Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
In stent restenosis rate (> 50% restenosis)
Angiography assessment at 12 months post-procedure
Measured: 12 months post-procedure
Secondary outcomes (13)
Stroke and death events
Measured: within 30 days after stenting
Target vessel ischemic stroke event
Measured: between 30 days and 1 year post-procedure
Acute procedural success rate (stenosis < 30%)
Measured: 1 year
Target vessel stroke or death events
Measured: within 30 days after stenting
Non-target vessels ischemic stroke event
Measured: between 30 days and 1 year post-procedure
Recurrent ischemic stroke in the involved vascular area
Measured: between 30 days and 1 year post-procedure
Cerebral parenchyma hemorrhage, subarachnoid hemorrhage and intraventricular bleeding events
Measured: between 30 days and 1 year post-procedure
Death event
Measured: between 30 days and 1 year post-procedure
Transient ischemic attack event
Measured: within 1 year post-procedure
National Institutes of Health Stroke Scale (NIHSS) evaluation
Measured: at 1 and 12 months
modulate RANK score （mRS）evaluation
Measured: at 1 and 12 months
Montreal Cognitive Assessment (MoCA) evaluation
Measured: at 1 and 12 months
EQ-5D score evaluation
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study start27 Apr 2015
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sino Medical Sciences Technology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
- Investigators
- Zhongrong Miao, M.D., Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578069
- Sponsor's protocol ID
- NOVA-001
- Acronym
- NOVA
- Status last verified
- Jan 2019
- First submitted
- 29 Sep 2015
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34982098
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of the NOVA Sirolimus Eluting Stent Versus the Apollo Stent
- ClinicalTrials.gov ID
- NCT02578069
- Acronym / sponsor ID
- NOVA / NOVA-001
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke, Intracranial Stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Sino Medical Sciences Technology Inc.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 27 Apr 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: NOVA Intracranial Sirolimus Eluting Stent SystemNOVA Intracranial sirolimus eluting stent system |
| Control | Active comparator | Device: Apollo Intracranial Stent SystemApollo Intracranial stent system |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (21 listed)
- >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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOVA Intracranial Sirolimus Eluting Stent SystemA 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. | Device | Experimental |
| Apollo Intracranial Stent SystemA 316L stainless steel balloon-expandable intracranial stent system | Device | Control |
Primary outcome
In stent restenosis rate (> 50% restenosis)
Time frame: 12 months post-procedure
Angiography assessment at 12 months post-procedure
13 secondary outcomes
Stroke and death events
Time frame: within 30 days after stenting
Target vessel ischemic stroke event
Time frame: between 30 days and 1 year post-procedure
Acute procedural success rate (stenosis < 30%)
Time frame: 1 year
Target vessel stroke or death events
Time frame: within 30 days after stenting
Non-target vessels ischemic stroke event
Time frame: between 30 days and 1 year post-procedure
Recurrent ischemic stroke in the involved vascular area
Time frame: between 30 days and 1 year post-procedure
Cerebral parenchyma hemorrhage, subarachnoid hemorrhage and intraventricular bleeding events
Time frame: between 30 days and 1 year post-procedure
Death event
Time frame: between 30 days and 1 year post-procedure
Transient ischemic attack event
Time frame: within 1 year post-procedure
National Institutes of Health Stroke Scale (NIHSS) evaluation
Time frame: at 1 and 12 months
modulate RANK score （mRS）evaluation
Time frame: at 1 and 12 months
Montreal Cognitive Assessment (MoCA) evaluation
Time frame: at 1 and 12 months
EQ-5D score evaluation
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Derived from this study: PubMed 34982098Jia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongrong Miao, M.D. principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOVA Intracranial Sirolimus Eluting Stent System and Apollo Intracranial Stent System in people with Ischemic Stroke, run by Sino Medical Sciences Technology Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In stent restenosis rate (> 50% restenosis) (time frame: 12 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02578069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.