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

NCT ID: NCT06559475

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2026-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Super-Bore Thrombosis Aspiration Catheter treatment group

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.

Group Type: EXPERIMENTAL

Super-Bore Thrombosis Aspiration Catheter treatment group

Intervention Type: 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.

Conventional thrombectomy device treatment group

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.

Group Type: ACTIVE_COMPARATOR

Conventional thrombectomy device treatment group

Intervention Type: 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.

Interventions

Super-Bore Thrombosis Aspiration Catheter treatment group

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.

Intervention Type: PROCEDURE

Conventional thrombectomy device treatment group

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Aged 18 years or older;

2. Clinical presentation consistent with acute ischemic stroke (AIS);

3. Able to receive mechanical thrombectomy within 24 hours of onset;

4. Pre-morbid mRS score of 0 or 1;

5. Baseline NIHSS score of 6 or greater;

6. 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;

7. Vessel diameter ≥2.2 mm at the occlusion site;

8. ASPECTS or PC-ASPECTS score of 6-10 on NCCT, CTA-source imaging, or DWI-MRI;

9. Written informed consent obtained from the patient or the patient's qualified representative.

Exclusion Criteria

1. Pregnant or lactating women;

2. Severe allergic reactions to contrast agents;

3. Current participation in other clinical studies;

4. Known hereditary or acquired bleeding disorders, platelet count <50,000/µL, or coagulation factor deficiencies;

5. Renal failure with serum creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30 mL/min;

6. Expected survival < 6 months or known cancer with metastases;

7. Clinical manifestations suggesting subarachnoid hemorrhage, despite normal CT or MRI findings;

8. Suspected aortic dissection;

9. 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);

10. 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;

11. Evidence of dissection in the extracranial or intracranial cerebral arteries;

12. Intracranial hemorrhage on CT or MRI;

13. Evidence of intracranial mass effect or tumor (except small meningiomas defined as ≤ 3cm and asymptomatic)) on CT or MRI;

14. Suspicious of cerebral vasculitis or infectious endocarditis;

15. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor;

16. Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic;

17. Excessive vascular access tortuosity or target vessel size that will likely prevent endovascular access with the Super-Bore Aspiration Catheters;

18. Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy devices;

19. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories as determined by the treating physician;

20. Known aneurysm at or near the target treatment segment;

21. Known glucose level< 50 mg/dl (2.78 mmol/L) or > 400 mg/dl (22.20 mmol/L)；

22. Patients who, in the opinion of the investigator, are unsuitable for mechanical thrombectomy as evidenced by imaging findings.

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

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Wei Hu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Hu, MD, PhD

Role: STUDY_CHAIR

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

Locations

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

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Hu, MD, PhD

Role: CONTACT

Phone: +86 055162284313

Email: andinghu@ustc.edu.cn

Facility Contacts

Wei Hu, MD,PhD

Role: primary

Other Identifiers

Super Aspiration

Identifier Type: -

Identifier Source: org_study_id