Acute Ischemic StrokeiNDUONCT07376447
Evaluation of iNstroke Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study
A study testing Thromboaspiration catheter in people with Acute Ischemic Stroke, run by iVascular S.L.U. at 11 sites in 2 countries.
Trial summary
Prospective, single-arm, multi-center study to confirm the performance and safety of the iNstroke 6F and 4F thromboaspiration catheter for the treatment of 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?
- Thromboaspiration catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients ≥ 18 years of age.
- Able to be treated (i.e., defined by arterial puncture time) within 24 hours of symptom onset or last time seen well (LTSW).
- Demonstrated occlusion in a large and/or medium vessel (carotid T, M1, proximal M2, M2-M3, A1, A2, A3, basilar artery, P1, P2, P3).
- Baseline NIHSS score ≥6 assessed before the procedure.
- Pre-morbid [xB13.1]stroke baseline mRS ≤ 2.
- Subjects with an ASPECTS ≥ 6.
- Informed consent signed by the subject or their representative, or notice of information, as per regulatory requirements, to collect the subject's data.
- As applicable by French laws, the subject is affiliated to a health social security regimen or equivalent (only to be answered by French sites).
Who cannot join
- Severe comorbidity and/or shortened life expectancy that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient.
- Severe allergy to contrast media.
- As applicable by French laws: breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of full age who are the subject of a legal protection measure.
- Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
- Multiple Intracranial Occlusions
- Known medical history of thrombocytopenia (Platelets <100,000).
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- Presence of intracerebral hemorrhage.
- Significant mass effect and/or midline shift.
- Evidence of intracranial tumor (except small meningioma).
- Intracranial stenosis proximal to the occlusion.
- Severe sustained hypertension (systolic pressure >185 mm Hg or diastolic pressure >110 mm Hg). Note: If blood pressure can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines (also IV infusion of antihypertensives), the patient may be included.
- Known or suspected cerebral vasculitis.
- Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
- Current participation in an interventional drug or device study that may confound the results of this study.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
France6 sites
CHU Bordeaux (H Pellegrin)
Bordeaux
Xavier Barreau, +34 936724711, clinica@ivascular.global
Xavier Barreau, Dr.
CHU Brest
Brest
Jean Christoph Gentric, +34 936724711, clinica@ivascular.global
Jean Christoph Gentric, Dr.
CHU Lille
Lille
Nicolas Bricout, +34 936724711, clinica@ivascular.global
Nicolas Bricout, Dr.
CHU Nancy
Nancy
Benjamin Gory, +34 936724711, clinica@ivascular.global
Benjamin Gory, Dr.
APHP Pitié Salpétrière
Paris
Clarencon Frédéric, +34 936724711, clinica@ivascular.global
Frédéric Clarencon, Dr.
CHU Strasbourg
Strasbourg
Raoul Pop, +34 936724711, clinica@ivascular.global
Frédéric Clarencon, Dr.
Germany5 sites
Klinikum Bremen Mitte
Bremen
Panagiotis Papanagiotou, +34 936724711, clinica@ivascular.global
Panagiotis Papanagiotou, Dr.
Universität zu Köln
Cologne
Christoph Kabbasch, +34 936724711, clinica@ivascular.global
Christoph Kabbasch, Dr.
Knappschaft Kliniken
Dortmund
Jens Altenbernd, +34 936724711, clinica@ivascular.global
Jens Altenbernd, Dr.
UKE Hamburg
Hamburg
Fabian Flottmann, +34 936724711, clinica@ivascular.global
Fabian Flottmann, Dr.
Klinikum Nürnberg
Nuremberg
Markus Holtmannspötter, +34 936724711, clinica@ivascular.global
Markus Holtmannspötter, Prof. Dr.
About this study
Official title: Confirmation of the Performance and Safety of the iNstroke 6F and 4F Thromboaspiration Catheter for the Treatment of Acute Ischemic Stroke
Prospective, single-arm, multi-center study to confirm the performance and safety of the iNstroke 6F and 4F thromboaspiration catheter for the treatment of acute ischemic stroke
Read the detailed description
This clinical investigation has been designed to generate further data demonstrating the safety and effectiveness of the iNstroke device as well as of the thrombectomy process for the treatment of large and medium vessel occlusions.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Thromboaspiration catheter
- 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.
Thromboaspiration catheterDevice
Patients to undergo thromboaspiration with iNstroke 6F and/or 4F
| Study group | Role | What they receive |
|---|---|---|
| Thromboaspiration using iNstroke 4F and/or iNstroke 6F aspiration catheter | Other | 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. Receives: Device: Thromboaspiration catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recanalization Rate
Recanalization rate with mTICI ≥2b in ≤3 revascularization passes using iNstroke Thrombus Extraction Aspiration Device aspiration catheter alone, or in conjunction with Stent Retriever.
Measured: Intra-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
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
- NCT07376447
- Sponsor's protocol ID
- iNDUO-01
- Acronym
- iNDUO
- Status last verified
- Nov 2026
- First submitted
- 22 Jan 2026
- Last updated
- 4 Nov 2026
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmation of the Performance and Safety of the iNstroke 6F and 4F Thromboaspiration Catheter for the Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07376447
- Acronym / sponsor ID
- iNDUO / iNDUO-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Ischemia, Thromboaspiration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- iVascular S.L.U.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Jan 2026 (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 confirm the performance and safety of the iNstroke 6F and 4F thromboaspiration catheter for the treatment of acute ischemic stroke
Detailed description
This clinical investigation has been designed to generate further data demonstrating the safety and effectiveness of the iNstroke device as well as of the thrombectomy process for the treatment of large and medium vessel occlusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thromboaspiration using iNstroke 4F and/or iNstroke 6F aspiration catheter | Other | Device: Thromboaspiration catheterNo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 18 years of age.
- Able to be treated (i.e., defined by arterial puncture time) within 24 hours of symptom onset or last time seen well (LTSW).
- Demonstrated occlusion in a large and/or medium vessel (carotid T, M1, proximal M2, M2-M3, A1, A2, A3, basilar artery, P1, P2, P3).
- Baseline NIHSS score ≥6 assessed before the procedure.
- Pre-morbid [xB13.1]stroke baseline mRS ≤ 2.
Key exclusion criteria (14 listed)
- Severe comorbidity and/or shortened life expectancy that will likely prevent improvement or follow up or that will render the procedure unlikely to benefit the patient.
- Severe allergy to contrast media.
- As applicable by French laws: breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of full age who are the subject of a legal protection measure.
- Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
- Multiple Intracranial Occlusions
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 |
|---|---|---|
| Thromboaspiration catheterPatients to undergo thromboaspiration with iNstroke 6F and/or 4F | Device | Thromboaspiration using iNstroke 4F and/or iNstroke 6F aspiration catheter |
Primary outcome
Recanalization Rate
Time frame: Intra-procedure
Recanalization rate with mTICI ≥2b in ≤3 revascularization passes using iNstroke Thrombus Extraction Aspiration Device aspiration catheter alone, or in conjunction with Stent Retriever.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thromboaspiration catheter in people with Acute Ischemic Stroke, run by iVascular S.L.U. at 11 sites in 2 countries.
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 8 inclusion and 14 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recanalization Rate (time frame: Intra-procedure). 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 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.