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Clinical Trials in Germany / NCT07376447
Starting soon Not applicable

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

NCT07376447 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2026-05-31
Last updated
2026-02-02

Condition(s) studied

Acute Ischemic Stroke

Investigational drug(s) / intervention(s)

Thromboaspiration catheter

Thromboaspiration catheter: Patients to undergo thromboaspiration with iNstroke 6F and/or 4F

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
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

More iVascular S.L.U. trials in Germany

Other trials for the same condition

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 NCT07376447 on ClinicalTrials.gov ↗ ← All trials in Germany