A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke (PHAST)

Neuravi

Status: Begins enrollment this month

Conditions: Ischemic Stroke

Treatments: Procedure: Adaptive Tip Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT07367100

CNV202304 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety and the effectiveness of the Adaptive Tip Catheter (ATC) used as a first line direct aspiration thrombectomy technique for patients suffering of an acute ischemic stroke.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than or equal to (>=) 18 years, less than or equal to (<=) 90 years, at the time of consent
• Signs and symptoms consistent with the diagnosis of acute ischemic stroke in the anterior circulation that can be treated with endovascular thrombectomy approaches
• Endovascular treatment can be initiated (defined as access puncture) within 24 hours from time last known well
• Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6
• A signed and dated Informed Consent Form (ICF) or Investigator Statement for emergency procedure (as allowed according to country regulations and approved by EC) has been obtained

Exclusion criteria

• Known pregnancy, as evidenced by positive pregnancy test for women of childbearing potential or breast feeding
• Life expectancy less than (<) 90 days prior to stroke onset
• Known hemorrhagic diathesis disorder, coagulation factor deficiency or oral anticoagulant therapy with known International Normalized Ratio (INR) greater than (>) 3.0
• Clinical symptoms and/or CT/MRI evidence suggestive of bilateral stroke or stroke in multiple vascular territories, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
• Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
• Computed Tomography/ Magnetic Resonance Imaging (CT/MRI) evidence of recent/fresh hemorrhage
• Baseline CT or MRI showing mass effect
• Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
• Cerebral catheter angiographic evidence of pre-existing arterial disease, that potentially impacts treatment and/or outcome (for example, vasculitis)
• Any occlusion or stenosis that limits device access to the target area (for example, carotid dissection, tandem occlusions) or requiring acute stenting to achieve access
• Cerebral catheter angiographic evidence of multiple cerebrovascular occlusions, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
• Excessive vascular access tortuosity that will likely prevent endovascular access with the adaptive tip catheter (ATC)
• Baseline expanded thrombolysis in cerebral infarction (eTICI) > 1

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Adaptive Tip Catheter (ATC)

Experimental group

Description:

The ATC will be used alone (direct aspiration) as the first attempted device/technique for mechanical thrombectomy in the anterior circulation in patients during the first three passes or until final reperfusion, if less than three passes are needed. Patients will be followed over 90 days post procedure.

Treatment:

Procedure: Adaptive Tip Catheter