Study Evaluating Toro 88 Super Bore Aspiration Catheter for Acute Ischemic Stroke

NCT ID: NCT07089355

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Participants with acute ischemic stroke will undergo mechanical thrombectomy using the Toro 88 Super Bore Aspiration Catheter as first-line treatment.

Group Type: EXPERIMENTAL

Toro 88 Super Bore Aspiration Catheter

Intervention Type: DEVICE

The Toro 88 Super Bore Aspiration Catheter is a neurovascular device designed for clot aspiration during mechanical thrombectomy procedures.

Interventions

Toro 88 Super Bore Aspiration Catheter

The Toro 88 Super Bore Aspiration Catheter is a neurovascular device designed for clot aspiration during mechanical thrombectomy procedures.

Intervention Type: DEVICE

Eligibility Criteria

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 :

• By the patient
• Or consent by a family member/trusted support person if the patient's condition does not allow them to express their consent in writing (L1111-6)

Exclusion Criteria

• Arterial dissection
• Suspicion of vasculitis
• Suspected intracranial stenosis near the occlusion site
• Concomitant intracranial haemorrhage
• Known coagulation disorder
• Known coagulopathy
• Known platelet count <50,000/μL
• Significant mass effect with midline shift
• Suspicion or evidence of aortic dissection, septic embolus, or bacterial endocarditis
• INR ≥ 3.0
• APTT ≥ 2 times normal
• Systolic blood pressure > 185 mmHg and/or diastolic blood pressure < 110 mmHg
• Blood glucose < 50 mg/dL or >400 mg/dL according to the last measurement taken before the procedure
• Known allergy to contrast media
• Occluded arteries in more than one large vascular territory (at least two of the left and right internal carotid arteries or the territory of a carotid artery and an artery of the vertebrobasilar system).
• Pregnant or breast-feeding women (urine or serum pregnancy test negative at inclusion).
• Adults under legal protection (L1121-8)
• Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L3212-1 and L3123-1 and persons admitted to a health or social establishment for purposes other than research (L1121-6).
• Participation in other interventional clinical research

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toro Neurovascular, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Fondation Adolphe de Rothschild

Paris, , France

Countries

France

Central Contacts

Cheffe de Service

Role: CONTACT

ayavchitz@for.paris

+33 01 48 03 64 54

Facility Contacts

Cheffe de Service

Role: primary

ayavchitz@for.paris

+33 1 48 03 64 54

Other Identifiers

P_RBC_2025_1

Identifier Type: -

Identifier Source: org_study_id