Tests a clot-removal catheter in people with acute ischaemic stroke
Tests a clot-removing catheter in adults with a sudden ischaemic stroke.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy
Key facts
- Where
- Barcelona, L'Hospitalet de Llobregat, Málaga, Vigo, and Zaragoza, SpainSee the 5 sites
Where in Spain
- Hospital Clínico de BarcelonaBarcelona, SpainNo longer taking part
- Hospital Universitario BellvitgeL'Hospitalet de Llobregat, SpainNo longer taking part
- Hospital Regional Universitario de Malaga Carlos HayaMálaga, SpainNo longer taking part
- Hospital Alvaro CunqueiroVigo, SpainNo longer taking part
- Hospital Universitario Miguel ServetZaragoza, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- iVascular S.L.U.
- Trial code
- NCT07571954
- Record updated
- 5 November 2026
- Original description
Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic strokeRead full original descriptionShow less
Prospective, Single-arm, Multi-centre Study to Evaluate the Efficacy and Safety of the Instroke 5F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke.
Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic stroke
Inclusion: 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: Current participation in an interventional drug or device study that may confound the results of this study; Severe allergy to contrast media; Subjects with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection; 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; Medical history of thrombocytopenia (Platelets <100,000); Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min; 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; 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; Women of child-bearing potential; 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; Known or suspected cerebral vasculitis; Intracranial stenosis proximal to the occlusion.