NCT05101668

Safety and Efficacy of Intracranial Thrombus Aspiration Catheter in the Treatment of Acute Large-vessel Occlusive Stroke

A Prospective, Multi-center, Single-arm Objective Performance Criteria Trial to Evaluate the Safety and Efficacy of Intracranial Thrombus Aspiration Catheter in Treatment of Acute Large-vessel Occlusive Stroke

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sinomed Neurovita Technology Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multicenter, single-arm objective performance criteria trial to investigate the safety and efficacy of SINOMED ADPAT for Recanalization Therapy in acute large-vessel occlusive stroke.

Detailed description

This study plans to recruit 164 patients with acute intracranial large-vessel occlusion within 24 hours time window. The Primary endpoint is the instant recanalization rate of target vessel after operation. Secondary efficacy endpoints will include: 1) immediate recanalization rate of the first pass of aspiration; 2) the recanalization time of the target vessel blood flow; 3) the improvement of the postoperative NIHSS score; 4) the ratio of good neurological function (mRS 0-2 points) at 90 days; 5) the success rate of device; 6) the success rate of operation; 7) The proportion of rescue therapy. Safety endpoints will include: 1) the incidence of symptomatic intracranial hemorrhage within 24 hours after operation; 2) all-cause death and stroke-related mortality at 90 days; 3) stroke recurrence rate within 90 days after operation; 4) surgery-related complications; 5) adverse events; 6) serious adverse events; 7) Device defection rate

Conditions

• Aspiration
• Acute Ischemic Stroke
• Large-vessel Occlusion

Interventions

Type	Name	Description
DEVICE	Intracranial Thrombosis Aspiration Catheter	Direct Aspiration

Timeline

• Start date: 2021-10-08
• Primary completion: 2022-07-18
• Completion: 2022-08-17
• First posted: 2021-11-01
• Last updated: 2023-04-27

Locations

6 sites across 1 country: China