Acute Ischemic Stroke, Intracranial Aneurysms
Conditions
Brief summary
The study objective is to evaluate the safety and effectiveness of Intracranial Distal Access Catheter in neurointerventional therapy.
Detailed description
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.
Interventions
DEVICEIntracranial Distal Access Catheter
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
Sponsors
Tianjin Happy Life Technology Co., Ltd.
MicroPort NeuroTech Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age = 18-80 years old. * 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 (such as poor vascular access conditions, lesions located in secondary or higher branches of cerebral vessels, inability of conventional guiding catheters in place and providing effective support. Treatment with Flow-divert devices, covered stents, stent grafts, etc.) * Patients agree to participate in the study and sign the informed consent form.（only prospective enrolled patients)
Exclusion criteria
* Intracranial Distal Access Catheter is used during the interventional therapy of non-neurovascular diseases, such as peripheral vascular and coronary artery diseases. * Interventional procedure is performed with other distal catheters or devices with the same function before using Intracranial Distal Access Catheter. Ordinary guiding catheters can be used to establish access to complete the procedure without the use of Intracranial Distal Access Catheter.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | immediately after procedure | 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% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheter delivery success rate | immediately after procedure | 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% |
| Incidence of device-related adverse events | from the procedure to patients discharged from the hospital, anticipated average 5 days | — |
| Incidence of device-related serious adverse events | from the procedure to patients discharged from the hospital, anticipated average 5 days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Device operation performance (supporting capability) | intra-procedure | The evaluation criteria for supporting capacity are as follows: * Excellent: During the delivery of therapeutic devices, the Intracranial Distal Access does not withdraw.. * Good: During the delivery of therapeutic devices, the Intracranial Distal Access Catheter withdraws slightly, but the adjustment has no significant impact on the procedure. * Poor: During the delivery of therapeutic devices, the Intracranial Distal Access Catheter withdraws seriously, requiring repeated adjustments to significantly prolong the procedure time. |
| Device operation performance (pushing resistance) | intra-procedure | The evaluation criteria for pushing resistance are as follows: * Excellent: Smooth push * Good: Slight resistance but not affecting use * Poor: Large resistance, affecting the proper placement and use |
| Device operation performance (device compatibility) | intra-procedure | The evaluation of device compatibility is to evaluate whether it can be compatible with other devices(such as Coils, Flow-divert devices, Stenosis stents, Thrombectomy Stents ) The evaluation criteria for device compatibility is * Yes * No |
Countries
China
Outcome results
None listed