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ClinicalTrials.gov ID

NCT07376447

Lead Sponsor

iVascular S.L.U.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

160Estimated

Last Update Posted

Feb 2, 2026Actual

Start Date

May 31, 2026Estimated

Primary Completion Date

Feb 28, 2027Estimated

Completion Date

Dec 31, 2027Estimated

Official Title

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

Brief 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.

• Acute Ischemic Stroke

• Thromboaspiration catheter

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.
11. 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.
12. Known or suspected cerebral vasculitis.
13. Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min.
14. Current participation in an interventional drug or device study that may confound the results of this study.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

iVascular S.L.U.INDUSTRY

clinica@ivascular.global+34 936724711

clinica@ivascular.global+34 936724711

clinica@ivascular.global+34 936724711

clinica@ivascular.global+34 936724711

clinica@ivascular.global+34 936724711

clinica@ivascular.global+34 936724711

clinica@ivascular.global+34 936724711

clinica@ivascular.global+34 936724711

clinica@ivascular.global+34 936724711

clinica@ivascular.global+34 936724711