Prospective, single-arm, multi-centre study to evaluate the efficacy and safety of the iNstroke 5F thromboaspiration catheter in patients with acute ischaemic stroke
This clinical investigation has been designed to evaluate the efficacy and safety of the iNstroke 5F aspiration catheter for its use in the treatment of LVO, with a view to comparing this product with standard therapy or with other similar products in a future pivotal clinical investigation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Patients to undergo thromboaspiration with iNstroke 5F
CHU Bordeaux (H Pellegrin)
Bordeaux, France
CHU Lille
Lille, France
Hospital Regional Universitario de Málaga Carlos Haya
Málaga, Andalusia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain
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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Hospital Clínico de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Catalonia, Spain
Hospital Álvaro Cunqueiro
Vigo, Galicia, Spain