Acute Ischemic StrokeANAISNCT05409430
ANAIS Study to Confirm the Safety and Performance of the ANA 5F Advanced Neurovascular Access®
A study testing Neurothrombectomy in people with Acute Ischemic Stroke, run by Anaconda Biomed S.L. at 3 sites in Spain.
Trial summary
Prospective, single-arm, multi-center study to assess the safety and performance of the ANA 5F Advanced Neurovascular Access®, in combination with a stent retriever in patients with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Neurothrombectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesSpain
- Study dates
- 9 May 2022to 10 Jul 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical
- Age ≥18 and ≤85 years.
- Informed consent obtained from subject or acceptable subject surrogate (i.e. next of kin, or legal representative).
- A new focal disabling neurologic deficit consistent with acute cerebral ischemia.
- Baseline NIHSS obtained prior to procedure ≥ 8 points and ≤ 25 points.
- Pre-ictal mRS score of 0 or 1.
Show all 16Show fewer
- Treatable as soon as possible and at least within 24 hours of symptom onset, defined as point in time when the subject was last seen well (at baseline) (Treatment start is defined as access puncture).
- Subjects being either (1) eligible for, and received, IV tPA/TNK within 3 hours of symptom onset or (2) ineligible for IV tPA/TNK treatment.
- Neuro Imaging
- Occlusion (TICI 0 or TICI 1 flow), of the terminal internal carotid artery, M1 or M2 segments of the middle cerebral artery, suitable for mechanical embolectomy, confirmed on conventional angiography.
- For patients treated ≤ 6 hours:
- MRI criterion: volume of diffusion restriction visually assessed ≤50 mL
- OR
- CT criterion: Alberta Stroke program early CT score (ASPECTS) 6 to 10 on baseline CT.
- For patients treated 6 to 24 hours. Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is > 1.8 and mismatch volume is > 15 ml)
- The subject is indicated for neurothrombectomy treatment with SOLITAIRE, by the Interventionalist.
Who cannot join
- Clinical
- Initially treated with a different thrombectomy device.
- Subject has suffered a stroke in the past 1 year.
- Occlusion (TICI 0 or TICI 1 flow) of the basilar or vertebral arteries.
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with antivitamin K, with INR >3.0.
Show all 29Show fewer
- Known baseline glucose of <50 mg/dL or >400 mg/dL.
- Severe, sustained hypertension (systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg).
- Serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
- History of life-threatening allergy (more than rash) to contrast medium.
- Known renal insufficiency with creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30 mL/min.
- Cerebral vasculitis.
- Subject is a current user or has a recent history of cocaine use.
- Pregnant and/or lactating woman.
- Patient participating in a study involving an investigational drug or device that would impact this study.
- Patients that are unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas).
- Neuro Imaging
- CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
- Angiographic evidence of vasculitis.
- Significant mass effect with midline shift.
- Evidence of complete occlusion, high grade stenosis or arterial dissection in the extracranial or internal carotid artery (ICA).
- Subjects with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion.
- Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
- Evidence of intracranial tumor.
- Suspicion of aortic dissection presumed septic embolus, or suspicion of bacterial endocarditis.
- Severe arterial tortuosity likely to prevent stable positioning of the guide catheter in the distal cervical segment (C1) or petrous segment (C2) of internal carotid artery (ICA).
- Technical
- Inability to create an arterial access and / or to advance a guide catheter due to anatomical or physiological restrictions (i.e. vasospasm).
- Inability of the guide catheter to obtain a stable position in the ICA.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari de la Vall d'Hebron
Barcelona
Hospital Universitari Dr. Josep Trueta
Girona
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
About this study
Official title: Prospective, Single-arm, Multi-center Study to Confirm the Safety and Performance of the ANA 5F Advanced Neurovascular Access®, in Combination With a Stent Retriever in Patients With Acute Ischemic Stroke (ANAIS)
Prospective, single-arm, multi-center study to assess the safety and performance of the ANA 5F Advanced Neurovascular Access®, in combination with a stent retriever in patients with acute ischemic stroke.
Read the detailed description
ANA 5F Advanced Neurovascular Access®: distal access catheter system designed to assist in neurovascular procedures by facilitating the insertion and guidance of other devices (i.e. retrieval devices and intravascular catheters) and temporarily restricting blood flow at the target position.
The objective of this study is to confirm the safety and performance of the ANA 5F device to be used as a tool to facilitate the Solitaire stent retriever placement and provide temporary restriction of blood flow in stroke patients undergoing neurothrombectomy for an acute large vessel occlusion (LVO) treated 24 hours from symptom onset (last time the subject was seen well).
Population: Up to 30 Participants with Acute Ischemic Stroke (AIS), indicated for treatment with ANA 5F device in combination with Solitaire stent retriever, whose stroke is attributable to an occlusion of a large artery in the neurovasculature.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Neurothrombectomy
- Keywords
- AIS
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurothrombectomyDevice
Also called Mechanical thrombectomy (MT)
The ANA 5F device is intended to be inserted, be navigated to the neurovascular anatomy inside an outer catheter and be used as a conduit for insertion and guidance of intravascular catheters and retrieval devices into a selected blood vessel. The funnel is deployed by retracting the conduit catheter and is intended, when deployed, to provide temporary vascular flow restriction.
The device is indicated for the introduction of interventional devices into the neuro vasculature, during interventions for restoring blood flow in patients experiencing acute ischemic stroke due to large vessel occlusion.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Acute Ischemic Stroke (AIS) | Experimental | Patients with Acute Ischemic Stroke (AIS), indicated for treatment with ANA 5F device in combination with Solitaire stent retriever, whose stroke is attributable to an occlusion of a large artery in the neurovasculature. Receives: Device: Neurothrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful reperfusion, defined as rate of patients achieving mTICI ≥2b.
Successful reperfusion, defined as rate of patients achieving mTICI ≥2b in the target vessel within three passes of the ANA 5F before the use of rescue therapy, assessed by the Core Lab.
Measured: Day0. Intraoperative
The composite of symptomatic Intracranial Hemorrhage (sICH) within 24 hours (-8 / +12 h) post-procedure, together with serious adverse device effects.
The composite of symptomatic Intracranial Hemorrhage (sICH) within 24 hours (-8 / +12 h) post-procedure, together with serious adverse device effects (excluding those already counted in sICH) at Day 5 (± 12 h) or discharge (whatever comes first).
Measured: 24 hours (-8 / +12 h) post-procedure
Secondary outcomes (1)
Occurrence of Intracranial Hemorrhage (ICH); any symptomatic or asymptomatic ICH
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start9 May 2022
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with Acute Ischemic Stroke (AIS), indicated for treatment with ANA 5F device in combination with Solitaire stent retriever, whose stroke is attributable to an occlusion of a large artery in the neurovasculature.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anaconda Biomed S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- René Spaargaren, MD, Study chair, Anaconda Biomed S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409430
- Sponsor's protocol ID
- ANA2201
- Acronym
- ANAIS
- Status last verified
- Jul 2023
- First submitted
- 31 May 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Multi-center Study to Confirm the Safety and Performance of the ANA 5F Advanced Neurovascular Access®, in Combination With a Stent Retriever in Patients With Acute Ischemic Stroke (ANAIS)
- ClinicalTrials.gov ID
- NCT05409430
- Acronym / sponsor ID
- ANAIS / ANA2201
- Conditions
- Acute Ischemic Stroke
- Keywords
- AIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Anaconda Biomed S.L.Industry (pharma, biotech, devices)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 8 Jun 2022 (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.
Prospective, single-arm, multi-center study to assess the safety and performance of the ANA 5F Advanced Neurovascular Access®, in combination with a stent retriever in patients with acute ischemic stroke.
Detailed description
ANA 5F Advanced Neurovascular Access®: distal access catheter system designed to assist in neurovascular procedures by facilitating the insertion and guidance of other devices (i.e. retrieval devices and intravascular catheters) and temporarily restricting blood flow at the target position.
The objective of this study is to confirm the safety and performance of the ANA 5F device to be used as a tool to facilitate the Solitaire stent retriever placement and provide temporary restriction of blood flow in stroke patients undergoing neurothrombectomy for an acute large vessel occlusion (LVO) treated 24 hours from symptom onset (last time the subject was seen well).
Population: Up to 30 Participants with Acute Ischemic Stroke (AIS), indicated for treatment with ANA 5F device in combination with Solitaire stent retriever, whose stroke is attributable to an occlusion of a large artery in the neurovasculature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with Acute Ischemic Stroke (AIS), indicated for treatment with ANA 5F device in combination with Solitaire stent retriever, whose stroke is attributable to an occlusion of a large artery in the neurovasculature.
| Arm | Type | Receives |
|---|---|---|
| Patients with Acute Ischemic Stroke (AIS) | Experimental | Device: NeurothrombectomyPatients with Acute Ischemic Stroke (AIS), indicated for treatment with ANA 5F device in combination with Solitaire stent retriever, whose stroke is attributable to an occlusion of a large artery in the neurovasculature. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Clinical
- Neuro Imaging
- OR
- For patients treated 6 to 24 hours. Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is > 1.8 and mismatch volume is > 15 ml)
Key exclusion criteria (29 listed)
- Clinical
- Neuro Imaging
- Technical
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 |
|---|---|---|
| NeurothrombectomyAlso: Mechanical thrombectomy (MT)The ANA 5F device is intended to be inserted, be navigated to the neurovascular anatomy inside an outer catheter and be used as a conduit for insertion and guidance of intravascular catheters and retrieval devices into a selected blood vessel. The funnel is deployed by retracting the conduit catheter and is intended, when deployed, to provide temporary vascular flow restriction. The device is indicated for the introduction of interventional devices into the neuro vasculature, during interventions for restoring blood flow in patients experiencing acute ischemic stroke due to large vessel occlusion. | Device | Patients with Acute Ischemic Stroke (AIS) |
Primary outcome
Successful reperfusion, defined as rate of patients achieving mTICI ≥2b.
Time frame: Day0. Intraoperative
Successful reperfusion, defined as rate of patients achieving mTICI ≥2b in the target vessel within three passes of the ANA 5F before the use of rescue therapy, assessed by the Core Lab.
The composite of symptomatic Intracranial Hemorrhage (sICH) within 24 hours (-8 / +12 h) post-procedure, together with serious adverse device effects.
Time frame: 24 hours (-8 / +12 h) post-procedure
The composite of symptomatic Intracranial Hemorrhage (sICH) within 24 hours (-8 / +12 h) post-procedure, together with serious adverse device effects (excluding those already counted in sICH) at Day 5 (± 12 h) or discharge (whatever comes first).
1 secondary outcome
Occurrence of Intracranial Hemorrhage (ICH); any symptomatic or asymptomatic ICH
Time frame: 90 days
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 20 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
René Spaargaren, MD study chair
Anaconda Biomed S.L.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurothrombectomy in people with Acute Ischemic Stroke, run by Anaconda Biomed S.L. at 3 sites in Spain.
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 16 inclusion and 29 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Successful reperfusion, defined as rate of patients achieving mTICI ≥2b. (time frame: Day0. Intraoperative). The study lists 2 primary outcomes in all. 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 20 Jul 2023.