Tests a clot suction catheter for acute ischemic stroke
Tests a suction catheter that removes clots in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Evaluation of iNstroke Aspiration Catheters for Thrombectomy: a Multi-center Prospective Study
Key facts
- Where
- Bremen, Cologne, Dortmund, Hamburg, and Nuremberg, GermanySee the 5 sites
Where in Germany
- Klinikum Bremen-MitteBremen, GermanyNo longer taking part
- Universität zu KölnCologne, GermanyNo longer taking part
- Knappschaft KlinikenDortmund, GermanyNo longer taking part
- UKE HamburgHamburg, GermanyNo longer taking part
- Klinikum NürnbergNuremberg, GermanyNo 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
- NCT07376447
- Record updated
- 4 November 2026
- Original description
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 strokeRead full original descriptionShow less
Confirmation of the Performance and Safety of the iNstroke 6F and 4F Thromboaspiration Catheter for the Treatment of Acute Ischemic Stroke
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
Inclusion: 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).
Exclusion: Current participation in an interventional drug or device study that may confound the results of this study; Severe allergy to contrast media; Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection; Presence of intracerebral hemorrhage; 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 medical history of thrombocytopenia (Platelets <100,000); Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min; 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; 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; Multiple Intracranial Occlusions; Significant mass effect and/or midline shift; Evidence of intracranial tumor (except small meningioma); Intracranial stenosis proximal to the occlusion; Known or suspected cerebral vasculitis.