The goal of this pilot study is to evaluate the safety and efficacy of the Toro 88 Super Bore Aspiration Catheter in acute ischemic stroke patients.
This is a prospective, open-label, single-arm, single-center clinical investigation evaluating the safety and efficacy of the Toro 88 Super Bore Aspiration Catheter in mechanical thrombectomy for acute ischemic stroke. The study is being conducted at the Hôpital Fondation Adolphe de Rothschild in France.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The Toro 88 Super Bore Aspiration Catheter is a neurovascular device designed for clot aspiration during mechanical thrombectomy procedures.
Hôpital Fondation Adolphe de Rothschild
Paris, France
Incidence of adverse events that may be associated with the use of the experimental device at 24-36h
Time frame: From start of procedure to 24-36 hours post-procedure
eTICI score ≥ 2b50 after a maximum of 3 passages with the experimental device
Time frame: Immediately after final device pass (intra-procedural)
Lesion site reached according to the operator
Time frame: Intra-procedural
eTICI score ≥ 2c after the first pass with the experimental device
Time frame: Immediately after first device pass (intra-procedural)
eTICI score ≥ 2b67 after the first pass with the experimental device
Time frame: Immediately after first device pass (intra-procedural)
Symptomatic intracranial haemorrhage
Symptomatic intracranial haemorrhage according to the SITS-MOST definition (Lancet 2007) : occurrence of an intraparenchymal haematoma (PH-2) on imaging, within 22-36 hours after reperfusion treatment, associated with a clinical worsening defined by a worsening of at least 4 NIHSS points.
Time frame: 22 to 36 hours after reperfusion
All adverse events
Time frame: From procedure to 90 days post-procedure
NIHSS score
Time frame: At discharge and at 90 days post-procedure
All serious adverse events
Time frame: From procedure to 90 days post-procedure
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All-cause death
Time frame: From procedure to 90 days post-procedure
Modified Rankin Score (mRS) ≤ 2
Time frame: At 90 days post-procedure