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
This clinical investigation has been designed to generate further data demonstrating the safety and effectiveness of the iNstroke device as well as of the thrombectomy process for the treatment of large and medium vessel occlusions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Patients to undergo thromboaspiration with iNstroke 6F and/or 4F
CHU Bordeaux (H Pellegrin)
Bordeaux, France
CHU Brest
Brest, France
CHU Lille
Lille, France
CHU Nancy
Nancy, France
Recanalization Rate
Recanalization rate with mTICI ≥2b in ≤3 revascularization passes using iNstroke Thrombus Extraction Aspiration Device aspiration catheter alone, or in conjunction with Stent Retriever.
Time frame: Intra-procedure
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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
...and 1 more locations