Acute Ischemic StrokeFIRSTNCT04072367
FIrst-Pass Reperfusion With the NeVa Stent-Retriever Trial
A study testing NeVa Stent Retrievers and Solitaire Stent Retrievers in people with Acute Ischemic Stroke, run by Vesalio.
Trial summary
This study is designed to compare the safety, performance and efficacy of blood clot (thrombus) removal in subjects presenting with acute ischemic stroke with the NeVa versus the Solitaire stent retrievers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- NeVa Stent Retrievers and Solitaire Stent Retrievers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia
- NIHSS score ≥ 6;
- Prestroke mRS score of ≤ 2;
- Angiographic confirmation by DSA of an occlusion (eTICI 0-1) of the intracranial ICA, MCA-M1, MCA-M2, basilar artery, or intracranial vertebral artery with or without tandem involvement of the cervical ICA or cervical vertebral artery;
- Imaging Criteria:
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- Strokes in the Anterior Circulation:
- Non-Contrast CT (NCCT): ASPECTS 6 to 10 on baseline CT, or
- CT perfusion (with Automated Volume Calculation): core infarct volume ≤ 70cc and Mismatch Ratio ≥ 1.5
- CT perfusion (without Automated Volume Calculation): ASPECTS 6 to 10 on the CBV maps with Visualized MTT or TMax - CBV Mismatch greater than 50%, or
- Brain MRI: ASPECTS 6 to 10 (and <70cc if Automated Volume Calculation is available) on baseline diffusion-weighted sequence (DWI).
- Strokes in the Posterior Circulation: pc-ASPECTS score 8 to 10 on baseline NCCT, CTA-source images, or DWI MRI.
- Subjects for whom IV-tPA is indicated and who are available for treatment, are treated with IV-tPA within 4.5 hours of stroke onset (onset time is defined as the last time when the subject was witnessed to be at baseline), with verification that the subject has received/is receiving the correct IV t-PA dose for the estimated weight
- Arterial puncture within 12 hours of symptom onset (or time last seen well - TLSW), thrombectomy procedure able to be completed within 2 hours from procedure start (arterial puncture).
- Subject or legal representative is able and willing to give informed consent.
Who cannot join
- Rapid neurological improvement prior to groin puncture suggestive of resolution of stroke
- Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
- Note: Subjects with a questionable seizure at onset of stroke should not be excluded if DSA confirms the presence of intracranial ICA and/or M1 occlusion, and accurate NIHSS can be obtained.
- Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
- Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
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- Cerebral vasculitis.
- History of severe allergy to contrast medium.
- Known allergy to stent retriever materials (nitinol, stainless steel);
- Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
- Active infection.
- Baseline CT or MRI showing mass effect or intracranial tumor (except small meningioma [≤ 3 cm]).
- CT or MRI evidence of recent/fresh hemorrhage on presentation.
- CTA, MRA, or DSA evidence of flow limiting carotid dissection, high-grade stenosis, or complete cervical carotid occlusion requiring stenting at the time of the index procedure (i.e., mechanical thrombectomy).
- Evidence of dissection in the intracranial cerebral arteries;
- Uncontrolled hypertension on presentation (defined as SBP > 220 mmHg and / or DBP > 120 mmHg). For subjects placed on intravenous BP medication, uncontrolled hypertension is defined as SBP > 185 mmHg and / or DBP > 110 mmHg.
- Baseline hemoglobin of < 7 mmol/L.
- Baseline platelet count < 50,000/uL.
- Renal failure as defined by a serum creatinine >3.0 mg/dL (264 mmol/L).
- Note: subjects on renal dialysis may be treated regardless of serum creatinine levels.
- Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with INR > 3.0 or PTT > 3 times normal. Subjects on factor Xa inhibitor for 24-48 h ago must have a normal PTT.
- Baseline blood glucose of < 50 mg/dL (2.78 mmol) or > 400 mg/dL (22.20 mmol). Note: The ''correction'' of baseline glucose or coagulation laboratory values to meet inclusion criteria will not be allowed.
- Females who are pregnant or breastfeeding.
- Known current or recent use of illicit drugs or alcohol abuse.
- Use of an investigational drug or device within past 3 months;
- Life expectancy less than 6 months.
- Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
About this study
Official title: A Prospective, Randomized, Open-Label, Multi-Center, Assessor-Blinded Study Designed to Compare the Safety, Performance and Efficacy of the NeVatm Stent Retriever Versus the Solitairetm Stent Retriever
This study is designed to compare the safety, performance and efficacy of blood clot (thrombus) removal in subjects presenting with acute ischemic stroke with the NeVa versus the Solitaire stent retrievers.
Read the detailed description
A pivotal, randomized, open label, assessor-blinded, 90-day study designed to compare the safety, performance and efficacy of thrombus removal in subjects aged ≥ 18 years presenting with acute ischemic stroke with the NeVa versus the Solitaire stent retrievers.
A total of 414 eligible subjects will be randomized in a 1:1 ratio to one of two treatment groups:
- Active Treatment Group
- Control Device
- Conditions
- Acute Ischemic Stroke
- Being tested
- NeVa Stent Retrievers, Solitaire Stent Retrievers
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeVa Stent RetrieversDevice
thrombus removal
Solitaire Stent RetrieversDevice
thrombus removal
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Group | Other | NeVa Stent Retrievers Receives: Device: NeVa Stent Retrievers |
| Control Device | Other | Solitare Stent Retrievers Receives: Device: Solitaire Stent Retrievers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reperfusion rate
The primary study endpoint is the reperfusion rate of the occluded target vessel (defined by an eTICI score ≥ 2b) following one single pass using the assigned stent retriever device(s)
Measured: post-procedure day 0
Secondary outcomes (1)
Stent retriever comparison
The secondary endpoint is the proportion of subjects treated with the NeVa device with good clinical outcomes at the Day 90 evaluation (defined as mRS score ≤ 2) when compared to the subjects treated with the predicate.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startDec 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: The study was withdrawn due to a change in company strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vesalio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raul Gomes Nogueira, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072367
- Sponsor's protocol ID
- VS-007
- Acronym
- FIRST
- Status last verified
- May 2020
- First submitted
- 26 Aug 2019
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label, Multi-Center, Assessor-Blinded Study Designed to Compare the Safety, Performance and Efficacy of the NeVatm Stent Retriever Versus the Solitairetm Stent Retriever
- ClinicalTrials.gov ID
- NCT04072367
- Acronym / sponsor ID
- FIRST / VS-007
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to a change in company strategy.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VesalioIndustry (pharma, biotech, devices)
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Aug 2019 (actual)
- 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.
This study is designed to compare the safety, performance and efficacy of blood clot (thrombus) removal in subjects presenting with acute ischemic stroke with the NeVa versus the Solitaire stent retrievers.
Detailed description
A pivotal, randomized, open label, assessor-blinded, 90-day study designed to compare the safety, performance and efficacy of thrombus removal in subjects aged ≥ 18 years presenting with acute ischemic stroke with the NeVa versus the Solitaire stent retrievers.
A total of 414 eligible subjects will be randomized in a 1:1 ratio to one of two treatment groups:
- Active Treatment Group
- Control Device
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Group | Other | Device: NeVa Stent RetrieversNeVa Stent Retrievers |
| Control Device | Other | Device: Solitaire Stent RetrieversSolitare Stent Retrievers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia
- NIHSS score ≥ 6;
- Prestroke mRS score of ≤ 2;
- Angiographic confirmation by DSA of an occlusion (eTICI 0-1) of the intracranial ICA, MCA-M1, MCA-M2, basilar artery, or intracranial vertebral artery with or without tandem involvement of the cervical ICA or cervical vertebral artery;
Key exclusion criteria (27 listed)
- Rapid neurological improvement prior to groin puncture suggestive of resolution of stroke
- Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes obtaining an accurate baseline NIHSS assessment.
- Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
- Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
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 |
|---|---|---|
| NeVa Stent Retrieversthrombus removal | Device | Active Treatment Group |
| Solitaire Stent Retrieversthrombus removal | Device | Control Device |
Primary outcome
Reperfusion rate
Time frame: post-procedure day 0
The primary study endpoint is the reperfusion rate of the occluded target vessel (defined by an eTICI score ≥ 2b) following one single pass using the assigned stent retriever device(s)
1 secondary outcome
Stent retriever comparison
Time frame: Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
Raul Gomes Nogueira, MD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing NeVa Stent Retrievers and Solitaire Stent Retrievers in people with Acute Ischemic Stroke, run by Vesalio.
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 15 inclusion and 27 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: withdrawn, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Reperfusion rate (time frame: post-procedure day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2023.