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Evaluation of iNstroke Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study | Clinical Trials | Clareo Health

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Evaluation of iNstroke Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study

Confirmation of the Performance and Safety of the iNstroke 6F and 4F Thromboaspiration Catheter for the Treatment of Acute Ischemic Stroke

NCT07376447•iVascular S.L.U.

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients ≥ 18 years of age.
•2. Able to be treated (i.e., defined by arterial puncture time) within 24 hours of symptom onset or last time seen well (LTSW).
•3. Demonstrated occlusion in a large and/or medium vessel (carotid T, M1, proximal M2, M2-M3, A1, A2, A3, basilar artery, P1, P2, P3).
•4. Baseline NIHSS score ≥6 assessed before the procedure.
•5. Pre-morbid \[xB13.1\]stroke baseline mRS ≤ 2.
•6. Subjects with an ASPECTS ≥ 6.
•7. Informed consent signed by the subject or their representative, or notice of information, as per regulatory requirements, to collect the subject's data.
•8. As applicable by French laws, the subject is affiliated to a health social security regimen or equivalent (only to be answered by French sites).

Exclusion Criteria

•1. 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.
•2. Severe allergy to contrast media.
•3. 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.
•4. Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection.
•5. Multiple Intracranial Occlusions
•6. Known medical history of thrombocytopenia (Platelets \<100,000).
•7. Presence of intracerebral hemorrhage.
•8. Significant mass effect and/or midline shift.
•9. Evidence of intracranial tumor (except small meningioma).
•10. Intracranial stenosis proximal to the occlusion.
+4 more criteria

Locations (11)

CHU Bordeaux (H Pellegrin)

Bordeaux, France

CHU Brest

Brest, France

CHU Lille

Lille, France

CHU Nancy

Nancy, France

APHP Pitié Salpétrière

Paris, France

CHU Strasbourg

Strasbourg, France

Klinikum Bremen Mitte

Bremen, Germany

Universität zu Köln

Cologne, Germany

Knappschaft Kliniken

Dortmund, Germany

UKE Hamburg

Hamburg, Germany

Key Dates

Start Date

May 31, 2026

Primary Completion Date

February 28, 2027

Completion Date

December 31, 2027

Last Updated

February 2, 2026

Enrollment

160

ESTIMATED participants

Conditions

Acute Ischemic Stroke

Interventions

Thromboaspiration catheter

DEVICE

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

NCT07253181

Acute Ischemic StrokeLarge Vessel Occlusion+1 more

View study

RECRUITINGPHASE2/PHASE3

Optimizing Reperfusion to Improve Outcomes and Neurologic Function

NCT06990867

Acute Ischemic Stroke

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of iNstroke Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study

Inclusion Criteria

Exclusion Criteria

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

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