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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNeuravi Limited

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Adaptive Tip Catheter

    Procedure/Surgery

    Patients will undergo mechanical thrombectomy using ATC.

Treatment groups

74 Participants
are divided into 1 treatment group
Group A: Adaptive Tip Catheter (ATC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Third Pass Reperfusion Assessed by Independent Imaging Core Lab

Successful achievement of the third pass reperfusion is defined as achieving an Expanded Thrombolysis in Cerebral Infarction (eTICI) score of 2b50 or greater using no more than three passes with the study device in the target vessel, and without any rescue therapy.

Time frame
Intraoperative

Secondary outcomes

1

First Pass Reperfusion

Successful achievement of the first pass reperfusion is defined as achieving an eTICI score of 2c or greater, as determined by the independent imaging core lab, with one pass of the study device in the target vessel, and without any rescue therapy.

Time frame
Intraoperative
2

Final Procedural Reperfusion

Successful achievement of the final procedural reperfusion is defined as achieving a final (end of procedure) eTICI score of 2b50 or greater in the target vessel as determined by the independent imaging core lab.

Time frame
Intraoperative
3

Modified Rankin Scale (mRS) Score of 0-2 at 90 days Post-Procedure

Percentage of patients with mRS score of 0-2 at 90 days or no change from baseline if pre-ictal mRS greater than (\>) 2 will be reported.

Time frame
At 90 days post-procedure
4

Vessel Damage

Number of patients with perforation or dissection in the blood vessel known to be related to or possibly related to the study device will be reported.

Time frame
At 90 days post-procedure

Other outcomes

Sponsors and contacts

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