Acute Ischemic StrokeASPiCNCT05720975
Efficacy and Safety Evaluation of the Thromboaspiration Catheter System iNstroke in Patients With Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by iVascular S.L.U. at 1 site in Spain.
Trial summary
First prospective, single-arm, single-centre study to evaluate the efficacy and safety of the iNstroke thromboaspiration catheter system (iNstroke) for stroke in patients with acute ischemic stroke. 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?
- iNstroke
- Type of treatment
- Medical device
- How many people
- 113 participants
- Where
- 1 siteSpain
- Study dates
- 26 Dec 2022to 7 Jan 2025
- Phase
- Observational
- 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
Study population: All consecutive patients experiencing acute ischaemic stroke of the anterior circulation with occlusion of TICA, M1, extracranial ICA, vertebral artery segment V4 or basilar artery, treated with iNstroke aspiration catheter and complying with the eligibility criteria.
Who may be able to join
- Patients with acute ischaemic stroke over 18 years of age caused by large vessel occlusion (TICA, extracranial ICA, M1, vertebral artery segment V4 or basilar artery) and receiving neurointerventional treatment with the iNstroke aspiration catheter.
- Informed consent signed by the patient or their representative, or deferred informed consent to avoid delaying commencement of mechanical thrombectomy.
- Patients with an ASPECTS (Alberta Stroke Program Early CT Score) score ≥ 6
- In patients having onset of stroke more than 8 hours previously, wake-up strokes, or unknown time of onset, treatment must be customised and CT perfusion must show penumbra.
- Initial NIHSS score before procedure > 6.
Who cannot join
- Patients under 18 years of age.
- Patients with an ASPECTS score <6.
- Baseline NIHSS obtained before procedure of ≤ 6 points.
- Severe comorbidity and/or shortened life expectancy
- mRS > 2.
- Serious allergy to contrast medium.
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- Pregnant women.
- Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection
- Personal history of thrombocytopaenia (<40,000 platelets)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First Prospective, Single-arm, Single-centre Study to Evaluate the Efficacy and Safety of the Thromboaspiration Catheter System (iNstroke) for Stroke in Patients With Acute Ischemic Stroke
First prospective, single-arm, single-centre study to evaluate the efficacy and safety of the iNstroke thromboaspiration catheter system (iNstroke) for stroke in patients with acute ischemic stroke.
Read the detailed description
This is a prospective, single-arm, single-centre clinical safety and efficacy research.
The purpose of the study is to evaluate safety and efficacy the device designed by iVascular for thromboaspiration (iNstroke) in patients who have suffered a stroke and who undergo thromboaspiration due to an acute occlusion of neuro vessels.
- Conditions
- Acute Ischemic Stroke
- Being tested
- iNstroke
- Keywords
- Stroke, Ischemia, Thromboaspiration
- Medical subject headings
- Ischemic Stroke, Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNstrokeDevice
Patients to undergo thromboaspiration with iNstroke.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: iNstroke | Study device Receives: Device: iNstroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance success
Recanalization rate with mTICI ≥2b-3 (modified thrombolysis in cerebral infarction scale).
Measured: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
MAE
All serious adverse events.
Measured: 24 hours (-8/+12 hours)
Mortality
All-cause mortality.
Measured: 90 days
Secondary outcomes (13)
Navigability
Number of procedures in which the InStroke catheter reaches the intracranial occluded segment (M1, basilar artery) through coaxial system with a microcatheter and without the assistance of other additional devices.
Measured: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Clinical progress
Good functional clinical progress (modified Rankin scale 0-2).
Measured: 90 days
Proportion of patients with rapid neurological improvement
Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS scale)
Measured: 24 hours
Reduction of NIHSS scale
Proportion of patients with a reduction of ≥8 points on the NIHSS scale (during the first 24 hours post-treatment), or NIHSS 0-1 (at 72 hours [or at the time of discharge, whichever occurs first]).
Measured: 24 or 72 hours
Procedure duration
Procedure duration defined as the time from puncture to when grade ≥2b is reached on the mTICI scale with less than three passes or, if not achieved, until the final angiogram.
Measured: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Number of passes with the device until recanalisation.
Number of passes with the device until recanalisation.
Measured: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Percentage of effective recanalisation in a first pass
Percentage of effective recanalisation in a first pass, the effect of which will be measured by a recanalisation rate of TICI2c-3 and TICI 2b-3.
Measured: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Rate of need to use another reperfusion technique
Rate of need to use another reperfusion technique due to suction system failure.
Measured: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Assessment of symptomatic intracerebral haemorrhage
Assessment of symptomatic intracerebral haemorrhage by magnetic resonance imaging (MRI)/computed tomography (CT). ICH is defined as the presence of extravascular blood in the brain or within the skull- ICH is considered symptomatic (SICH) if it is associated with clinical deterioration (worsening of the score National Institutes of Health Stroke Scale (NIHSS) of
≥4 points) or if it causes death and is identified as the predominant cause of neurological deterioration, according to the assessment of an independent clinical events committee (CEC).
Measured: 24 (-8/+12) hours.
Neurological deterioration
Classification of neurological deterioration of ≥4 points on the NIHSS scale.
Measured: 24 (-8/+12) hours.
Embolization rate
Embolization rate in a previously non-involved territory on cerebral angiography.
Measured: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Mortality rate
Mortality rate related to the procedure
Measured: 3 days (+/-24 hours) or at discharge, whichever occurs first.
Procedure complication rate
Procedure complication rate: arterial perforation, arterial dissection and severe vasospasm in the target vessel
Measured: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start26 Dec 2022
- Primary completion7 Jan 2025
- Study completion7 Jan 2025
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- iVascular S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720975
- Sponsor's protocol ID
- ASPiC-01
- Acronym
- ASPiC
- Status last verified
- May 2025
- First submitted
- 21 Jul 2022
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Prospective, Single-arm, Single-centre Study to Evaluate the Efficacy and Safety of the Thromboaspiration Catheter System (iNstroke) for Stroke in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05720975
- Acronym / sponsor ID
- ASPiC / ASPiC-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Ischemia, Thromboaspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- iVascular S.L.U.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 9 Feb 2023 (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.
First prospective, single-arm, single-centre study to evaluate the efficacy and safety of the iNstroke thromboaspiration catheter system (iNstroke) for stroke in patients with acute ischemic stroke.
Detailed description
This is a prospective, single-arm, single-centre clinical safety and efficacy research.
The purpose of the study is to evaluate safety and efficacy the device designed by iVascular for thromboaspiration (iNstroke) in patients who have suffered a stroke and who undergo thromboaspiration due to an acute occlusion of neuro vessels.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: iNstroke | – | Device: iNstrokeStudy device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients experiencing acute ischaemic stroke of the anterior circulation with occlusion of TICA, M1, extracranial ICA, vertebral artery segment V4 or basilar artery, treated with iNstroke aspiration catheter and complying with the eligibility criteria.
Key inclusion criteria (5 listed)
- Patients with acute ischaemic stroke over 18 years of age caused by large vessel occlusion (TICA, extracranial ICA, M1, vertebral artery segment V4 or basilar artery) and receiving neurointerventional treatment with the iNstroke aspiration catheter.
- Informed consent signed by the patient or their representative, or deferred informed consent to avoid delaying commencement of mechanical thrombectomy.
- Patients with an ASPECTS (Alberta Stroke Program Early CT Score) score ≥ 6
- In patients having onset of stroke more than 8 hours previously, wake-up strokes, or unknown time of onset, treatment must be customised and CT perfusion must show penumbra.
- Initial NIHSS score before procedure > 6.
Key exclusion criteria (9 listed)
- Patients under 18 years of age.
- Patients with an ASPECTS score <6.
- Baseline NIHSS obtained before procedure of ≤ 6 points.
- Severe comorbidity and/or shortened life expectancy
- mRS > 2.
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 |
|---|---|---|
| iNstrokePatients to undergo thromboaspiration with iNstroke. | Device | Experimental: iNstroke |
Primary outcome
Performance success
Time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Recanalization rate with mTICI ≥2b-3 (modified thrombolysis in cerebral infarction scale).
MAE
Time frame: 24 hours (-8/+12 hours)
All serious adverse events.
Mortality
Time frame: 90 days
All-cause mortality.
13 secondary outcomes
Navigability
Time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Clinical progress
Time frame: 90 days
Proportion of patients with rapid neurological improvement
Time frame: 24 hours
Reduction of NIHSS scale
Time frame: 24 or 72 hours
Procedure duration
Time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Number of passes with the device until recanalisation.
Time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Percentage of effective recanalisation in a first pass
Time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Rate of need to use another reperfusion technique
Time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Assessment of symptomatic intracerebral haemorrhage
Time frame: 24 (-8/+12) hours.
Neurological deterioration
Time frame: 24 (-8/+12) hours.
Embolization rate
Time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
Mortality rate
Time frame: 3 days (+/-24 hours) or at discharge, whichever occurs first.
Procedure complication rate
Time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.
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 9 May 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by iVascular S.L.U. at 1 site 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 5 inclusion and 9 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 9 May 2025. 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 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?
Performance success (time frame: In the course of cervico-cranial catheterization, evaluated immediately after endovascular procedure.). The study lists 3 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 9 May 2025.