The study objective is to evaluate the safety and effectiveness of Intracranial Distal Access Catheter in neurointerventional therapy.
Patients with mechanical thrombectomy for acute ischemic stroke, treatment of intracranial aneurysms and other ischemic and hemorrhagic diseases, requiring the use of Intracranial Distal Access Catheter to complete the procedure were eligible. At last, 124 retrospective and prospective subjects in 6 centers were screened in this trial, and 114 subjects were successfully enrolled.
Study Type
OBSERVATIONAL
Enrollment
114
Patients with mechanical thrombectomy for acute ischemic stroke, treatment of intracranial aneurysms and other ischemic and hemorrhagic diseases, requiring the use of Intracranial Distal Access Catheter(X-Track) to complete the procedure
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
Jiangmen Xinhui District People's Hospital
Jiangmen, Guangdong, China
Xinxiang Central Hospital
Xinxiang, Henan, China
The Sixth People's Hospital of Nantong
Nantong, Jiangsu, China
Technical success rate
It is defined as the proportion of subjects where Intracranial Distal Access Catheter can reach the expected position to successfully deliver the device and meet the treatment needs. Special note: If the patient uses more than one Intracranial Distal Access Catheters during the procedure, as long as any Intracranial Distal Access Catheter is delivered successfully, the patient is considered to achieve successful delivery with Intracranial Distal Access Catheter. Technical success rate (%) = number of patients successfully delivered/number of patients analyzed \* 100%
Time frame: immediately after procedure
Catheter delivery success rate
It is defined as the proportion of Intracranial Distal Access Catheter where Intracranial Distal Access Catheter can reach the expected position to successfully deliver the device and meet the treatment needs. Special note: If the patient uses more than one Intracranial Distal Access Catheters during the procedure, the statistics are based on whether the delivery of each Intracranial Distal Access Catheter is successful or not. Catheter delivery success rate (%) = number of successful catheter delivery/total number of catheters used \* 100%
Time frame: immediately after procedure
Incidence of device-related adverse events
Time frame: from the procedure to patients discharged from the hospital, anticipated average 5 days
Incidence of device-related serious adverse events
Time frame: from the procedure to patients discharged from the hospital, anticipated average 5 days
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People's Hospital of Rizhao
Rizhao, Shandong, China
The Affiliated Hospital of Yunnan University
Kunming, Yunnan, China