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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of University of Science and Technology of China

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Super-Bore Thrombosis Aspiration Catheter treatment group
  • Conventional thrombectomy device treatment group

Treatment groups

360 Participants
are divided into 2 treatment groups

Locations

1
The First Affiliated Hospital of University of Science and Technology of China HefeiAnhui, China

Sponsors and collaborators

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

Lead sponsor