Intracranial Distal Access Catheter in Neurointerventional Therapy

MicroPort

Status: Completed

Conditions: Intracranial Aneurysms; Acute Ischemic Stroke

Treatments: Device: Intracranial Distal Access Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT06989931

STA-2023-01-0A

Details and patient eligibility

About

The study objective is to evaluate the safety and effectiveness of Intracranial Distal Access Catheter in neurointerventional therapy.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

114 participants in 1 patient group

Subjects who using the Intracranial Distal Access Catheter to complete the procedure

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 (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, etc.)

Treatment:

Device: Intracranial Distal Access Catheter