An interventional study of Thromboaspiration catheter in Acute Ischemic Stroke, sponsored by iVascular S.L.U.. Active, not recruiting at 11 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by iVascular S.L.U. · Not applicable, Interventional, and Treatment
Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the iNstroke 4F Thromboaspiration Catheter in Patients with Acute Ischaemic Stroke due to Primary Distal Medium Vessel Occlusions.
This study is an exploratory, interventional, open label, single-arm, multi-centre prospective clinical investigation.
In this post-market clinical investigation, the aim is to further evaluate the efficacy and safety of the iNstroke 4F aspiration catheter, with a view to, in future clinical investigations, comparing the product with the standard therapy or with other similar products. In addition, this clinical investigation will generate results that could be used to further assess the safety and effectiveness of mechanical thrombectomy for the treatment of DMVO.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 57 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →iVascular S.L.U. is the lead sponsor of 14 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No comparator will be used in this clinical investigation as it is an exploratory study of a CE-marked medical device to be used within the scope of its intended purpose.
Device: Thromboaspiration catheter
Patients to undergo thromboaspiration with iNstroke 4F
Recanalization Endpoint
Recanalization rate with a modified thrombolysis in cerebral infarction scale (mTICI) score ≥2b in ≤3 revascularization passes using iNstroke 4F aspiration catheter, alone or in conjunction with a SR.
Time frame: Intra-procedure
Recanalization Endpoint
Proportion of subjects treated with iNstroke 4F alone with complete recanalization in primary DMVO defined as an mTICI ≥2b, after iNstroke 4F aspiration catheter alone (ADAPT) was used as a first-line therapy
Time frame: Intra-procedure
Recanalization Endpoint
Proportion of subjects treated with iNstroke 4F in conjunction with a stent retriever having complete recanalization in primary DMVO defined as achieving an mTICI ≥2b, after iNstroke 4F aspiration catheter, in conjunction with a stent retriever (SR), was used as a first-line therapy.
Time frame: Intra-procedure
Recanalization Endpoint
Proportion of subjects with mTICI≥2b, mTICI≥2c and mTICI 3 after first pass with iNstroke 4F aspiration catheter used both alone and in conjunction with a SR.
Time frame: Intra-procedure
Recanalization Endpoint
Time from groin puncture to achievement of complete recanalization (mTICI ≥2b), or if not achieved, until the final angiogram time, in patients treated with iNstroke 4F aspiration catheter, alone or in conjunction with a SR, as a first-line therapy.
Time frame: Intra-procedure
Recanalization Endpoint
Proportion of subjects in which direct contact with thrombus is achieved with iNstroke 4F aspiration catheter.
Time frame: Intra-procedure
Clinical Endpoint
Proportion of subjects achieving a modified Rankin scale (mRS) score of 0-2 at the 90-day (±14 days) post-procedure follow-up visit.
Time frame: 90 day
Safety Endpoint
Occurrence of SICH (according to SITS-MOST (13) and ECASS criteria (14)) within 24 (-8/+12) hours post-procedure, assessed by magnetic resonance imaging (MRI)/computed tomography (CT). Intracerebral Haemorrhage (ICH) is defined as the presence of extravascular blood in the brain or within the skull (local or remote parenchymal hematoma type 2, subarachnoid haemorrhage, and/or intraventricular haemorrhage) detected on the post-procedure imaging scan. ICH is considered symptomatic (SICH) if it is associated with a clinical deterioration, determined by a worsening/increase on the National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points, or if it causes death and is identified as the predominant cause of neurological deterioration.
Time frame: 24 (-8/+12) hours
Safety Endpoint
Occurrence of embolization in a previously non-involved (or new) territory as seen on the final control angiogram at the end of the procedure.
Time frame: Intra-procedure
Safety Endpoint
Occurrence of embolization in distal medium territory to the proximal occlusion as seen on the final control angiogram at the end of the procedure.
Time frame: Intra-procedure
Safety Endpoint
Inhospital mortality rate related to the procedure during hospital admission.
Time frame: During hospital admission
Safety Endpoint
Occurrence of devices and procedure related adverse events within 90 days (±14 days) after the procedure.
Time frame: 90 days (±14 days) after the procedure.
Safety Endpoint
Occurrence of procedure-related complications: arterial perforation, arterial dissection and severe vasospasm in the target vessel.
Time frame: Intra-procedure
Exploratory Recanalization Endpoint
Proportion of subjects in which a switch of technique (from ADAPT to combined or from combined to ADAPT) with iNstroke 4F aspiration catheter was used to successfully perform the thrombectomy.
Time frame: Intra-procedure
Exploratory Recanalization Endpoint
Proportion of subjects in which an aspiration catheter device with a 4F caliber different from iNstroke 4F aspiration catheter was used as a rescue therapy.
Time frame: Intra-procedure
Exploratory Recanalization Endpoint
Proportion of cases in which iNstroke 4F aspiration catheter (alone or in conjunction with a SR) successfully reached the site of occlusion.
Time frame: Intra-procedure
Exploratory Recanalization Endpoint
Number of passes with iNstroke 4F aspiration catheter until recanalization.
Time frame: Intra-procedure
Exploratory Recanalization Endpoint
Visibility of the catheter during the thrombectomy rated from 0 to 5 (being 0 the worst and 5 the best score).
Time frame: Intra-procedure
Exploratory Clinical Endpoint
Proportion of subjects with rapid neurological improvement, defined as a decrease of more than 4 points on the NIHSS scale, during the first 24 (-8/+12) hours post-procedure.
Time frame: 24 (-8/+12) hours post-procedure.
Exploratory Clinical Endpoint
Proportion of subjects with a reduction of ≥8 points on the NIHSS scale during the first 24 (-8/+12) hours post-procedure, or with a NIHSS score of 0-1 at 3 days (±24 hours) or at the time of discharge, whichever occurs first.
Time frame: First 24 (-8/+12) hours post-procedure or 3 days (±24 hours) or at the time of discharge, whichever occurs first.
Exploratory Clinical Endpoint
Median of NIHSS score at 24 (-8/+12) hours.
Time frame: 24 (-8/+12) hours.
Exploratory Clinical Endpoint
Median of NIHSS score at 3 days (±24 hours) or at the time of patient discharge, whichever occurs first.
Time frame: 3 days (±24 hours) post procedure
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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