A Multicenter, Randomized Controlled Clinical Investigation to Evaluate the Safety and Effectiveness of the Super-Bore 8/7F Aspiration Catheters in the Treatment of Acute Intracranial Large Vessel Occlusion

NCT06559475 | Recruiting DMC

• 1 other identifier: Super Aspiration
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

To Evaluate the Safety and Efficacy of the Super-Bore 8/7F Thrombosis Aspiration Catheter in the Treatment of Acute Intracranial Large Vessel Occlusion.

Conditions

Acute Ischemic Stroke; Endovascular Thrombectomy

Keywords

Acute Ischemic Stroke; Super-Bore 8F Thrombosis Aspiration Catheter; Acute Intracranial Large Vessel Occlusion

Outcome Measures

Primary Outcomes (1)

• The Rates of First Pass Effect (eTICI2c-3)

  Evaluate effect of thrombectomy on reperfusion

  Within 5 minutes at final angiography of thrombectomy

Secondary Outcomes (2)

• Proportion of mRS 0-2 at 90 days

  90 (± 14 days) after procedure

• 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (Ordinal Shift Analysis);

  90 (± 14 days) after procedure

Other Outcomes (2)

• Symptomatic intracerebral hemorrhage (sICH)

  24-48 hours after procedure

• mortality

  90 (± 14 days) after procedure

Study Arms (2)

Super-Bore Thrombosis Aspiration Catheter treatment group

EXPERIMENTAL

For the subjects randomized to the Super-Bore Thrombosis Aspiration Catheter treatment group, mechanical thrombectomy will be performed using a Super-Bore 8/7F Thrombosis Aspiration Catheter.

Procedure: Super-Bore Thrombosis Aspiration Catheter treatment group

Conventional thrombectomy device treatment group

ACTIVE COMPARATOR

For the subjects randomized to the conventional thrombectomy device treatment group, mechanical thrombectomy will be performed using a commonly used thrombectomy devices in clinic, except for Super-Bore 8/7F Thrombosis Aspiration Catheter.

Procedure: Conventional thrombectomy device treatment group

Interventions

Super-Bore Thrombosis Aspiration Catheter treatment group PROCEDURE

For the subjects randomized to the Super-Bore Thrombosis Aspiration Catheter treatment group, Mechanical thrombectomy will be performed using a Super-Bore 8/7F Thrombosis Aspiration Catheter.

Super-Bore Thrombosis Aspiration Catheter treatment group

Conventional thrombectomy device treatment group PROCEDURE

For the subjects randomized to the conventional thrombectomy device treatment group, mechanical thrombectomy will be performed using a commonly used thrombectomy devices in clinic, except for Super-Bore 8/7F Thrombosis Aspiration Catheter.

Conventional thrombectomy device treatment group

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older;
• Clinical presentation consistent with acute ischemic stroke (AIS);
• Able to receive mechanical thrombectomy within 24 hours of onset;
• Pre-morbid mRS score of 0 or 1;
• Baseline NIHSS score of 6 or greater;
• Complete or near-complete occlusion (eTICI 0-1) of the intracranial segment of the internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or the basilar artery (with or without involvement of the intracranial vertebral artery) confirmed by angiography who can undergo intravascular thrombectomy;
• Vessel diameter ≥2.2 mm at the occlusion site;
• ASPECTS or PC-ASPECTS score of 6-10 on NCCT, CTA-source imaging, or DWI-MRI;
• Written informed consent obtained from the patient or the patient's qualified representative.

You may not qualify if:

• Pregnant or lactating women;
• Severe allergic reactions to contrast agents;
• Current participation in other clinical studies;
• Known hereditary or acquired bleeding disorders, platelet count \<50,000/µL, or coagulation factor deficiencies;
• Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) \<30 mL/min;
• Expected survival \< 6 months or known cancer with metastases;
• Clinical manifestations suggesting subarachnoid hemorrhage, despite normal CT or MRI findings;
• Suspected aortic dissection;
• Known arterial condition in a proximal vessel that requires treatment or prevents access to the site of occlusion or safe recovery of the investigational device (for example, severe stenosis, complete occlusion in the cervical ICA, tandem occlusion);
• High degree of suspicion of intracranial arterial disease (ICAD), such as evidence of multifocal ICAD on CTA, MRA, or DSA, or any other finding that is highly suggestive of ICAD as the underlying etiology of the occlusion;
• Evidence of dissection in the extracranial or intracranial cerebral arteries;
• Intracranial hemorrhage on CT or MRI;
• Evidence of intracranial mass effect or tumor (except small meningiomas defined as ≤ 3cm and asymptomatic)) on CT or MRI;
• Suspicious of cerebral vasculitis or infectious endocarditis;
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor;

Sponsors & Collaborators

• The First Affiliated Hospital of University of Science and Technology of China: lead

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Wei Hu, MD, PhD

  The First Affiliated Hospital of University of Science and Technology of China

  STUDY CHAIR

Central Study Contacts

Wei Hu, MD, PhD

CONTACT

+86 055162284313; andinghu@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: December 16, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)