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Starting soon Not applicable

Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy

NCT07571954 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-08-31
Last updated
2026-05-13

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

Thromboaspiration catheter

Thromboaspiration catheter: Patients to undergo thromboaspiration with iNstroke 5F

Study summary

Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic stroke

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Subjects aged ≥ 18 years. * Subjects able to be treated (i.e., defined by groin puncture time) within 24 hours of symptom onset or last time seen well. * Occlusion in a large or proximal medium vessel (M1, proximal M2, A2 or P2) identified by magnetic resonance angiography (MRA) or computed tomography angiography (CTA). * Baseline NIHSS score ≥ 6 assessed before the procedure. * Pre-stroke mRS score ≤ 2. * Subjects with an ASPECTS score ≥ 6. * Informed consent obtained in accordance with the applicable country-specific regulations and as approved by the Ethics Committee (EC). * France-specific inclusion criteria: As applicable under French law, subjects affiliated with a health social security scheme or equivalent. Exclusion Criteria: * 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. * Women of child-bearing potential. * Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection. * Medical history of thrombocytopenia (Platelets \<100,000). * Subjects with tandem occlusions (evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery). * Subjects with occlusions in multiple vessels. * Subjects with cancer who have a life expectancy of less than 6 months. * Pre-existing neurological or psychiatric illness that could confound the neurological or functional assessments. * 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 subject 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. * Intracranial stenosis proximal to the occlusion. * France-specific exclusion criteria: As applicable under French law, breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, or persons of legal age who are the subject of a legal protection measure.

Primary outcome measure(s)

  • Recanalization Rate — 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

Trial sites (7)

FacilityCityRegionStatus
CHU Bordeaux (H Pellegrin) Bordeaux France
CHU Lille Lille France
Hospital Regional Universitario de Málaga Carlos Haya Málaga Andalusia
Hospital Universitario Miguel Servet Zaragoza Aragon
Hospital Clínico de Barcelona Barcelona Barcelona
Hospital Universitario Bellvitge L'Hospitalet de Llobregat Catalonia
Hospital Álvaro Cunqueiro Vigo Galicia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07571954 on ClinicalTrials.gov ↗ ← All trials in France