Intracranial Distal Access Catheter in Neurointerventional Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-07

Study Completion Date

2024-03-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acute Ischemic Stroke Intracranial Aneurysms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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

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.)

Intracranial Distal Access Catheter

Intervention Type DEVICE

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

Interventions

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Intracranial 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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No