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

NCT07089355 | Not Yet Recruiting DMC

• 1 other identifier: P_RBC_2025_1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Mechanical Thrombectomy; Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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

• 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

  22 to 36 hours after reperfusion

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Device: Toro 88 Super Bore Aspiration Catheter

Interventions

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Toro Neurovascular, Inc.: lead

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Cheffe de Service

CONTACT

+33 01 48 03 64 54; ayavchitz@for.paris

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 28, 2025
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)