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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Participants with acute ischemic stroke will undergo mechanical thrombectomy using the Toro 88 Super Bore Aspiration Catheter as first-line treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toro 88 Super Bore Aspiration Catheter | Device | The Toro 88 Super Bore Aspiration Catheter is a neurovascular device designed for clot aspiration during mechanical thrombectomy procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events that may be associated with the use of the experimental device at 24-36h | From start of procedure to 24-36 hours post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| eTICI score ≥ 2b50 after a maximum of 3 passages with the experimental device | Immediately after final device pass (intra-procedural) | |
| Lesion site reached according to the operator | Intra-procedural |
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Inclusion Criteria:
Patients aged ≥ 18 and ≤ 90 years at the time of consent
Presenting with an acute ischaemic stroke for which symptoms (or last time seen as normal) are < 24h
With occlusion of the ICA / the M1 segment of the MCA / a vertebral artery diameter ≥3.5mm / the basilar artery, defined by eTICI≤1
Requiring endovascular treatment (mechanical thrombectomy) with or without intravenous thrombolysis
For whom the experimental device is the first-line treatment
Without pre-existing disability (mRS ≤3 and 6≤ NIHSS ≤30 before stroke)
Informed consent signed :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheffe de Service | Contact | +33 01 48 03 64 54 | ayavchitz@for.paris |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Fondation Adolphe de Rothschild | Paris | 75019 | France |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| eTICI score ≥ 2c after the first pass with the experimental device | Immediately after first device pass (intra-procedural) |
| eTICI score ≥ 2b67 after the first pass with the experimental device | 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. | 22 to 36 hours after reperfusion |
| All adverse events | From procedure to 90 days post-procedure |
| NIHSS score | At discharge and at 90 days post-procedure |
| All serious adverse events | From procedure to 90 days post-procedure |
| All-cause death | From procedure to 90 days post-procedure |
| Modified Rankin Score (mRS) ≤ 2 | At 90 days post-procedure |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |