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

Starting soon · Not applicable

Conditions studied: Acute Ischemic Stroke

In brief

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

Key facts

Study ID

NCT07376447

Run by

iVascular S.L.U.

People needed

160

Starts

2026-05-31

Expected to finish

2027-12-31

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).
• 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.

Where it is running

• 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
• Klinikum Nürnberg — Nuremberg, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.