Clinical trial NCT06989931: Intracranial Distal Access Catheter in Neurointerventional Therapy
Official title: A Clinical Study on the Safety and Effectiveness of Intracranial Distal Access Catheter in Neurointerventional Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Intracranial Aneurysms
Lead sponsor: MicroPort NeuroTech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Tianjin Happy Life Technology Co., Ltd.
First posted: 2025-05-25
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Technical success rate
timeFrame: immediately after procedure
Secondary outcomes:
measure: Catheter delivery success rate
timeFrame: immediately after procedure
measure: Incidence of device-related adverse events
timeFrame: from the procedure to patients discharged from the hospital, anticipated average 5 days
measure: Incidence of device-related serious adverse events
timeFrame: from the procedure to patients discharged from the hospital, anticipated average 5 days
Other outcomes:
measure: Device operation performance (device compatibility)
timeFrame: intra-procedure
measure: Device operation performance (supporting capability)
timeFrame: intra-procedure
measure: Device operation performance (pushing resistance)
timeFrame: intra-procedure
Locations:
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
state: Fujian
city: Jiangmen
country: China
facility: Jiangmen Xinhui District People's Hospital
state: Guangdong
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
state: Henan
city: Nantong
country: China
facility: The Sixth People's Hospital of Nantong
state: Jiangsu
city: Rizhao
country: China
facility: People's Hospital of Rizhao
state: Shandong
city: Kunmin
country: China
facility: The Affiliated Hospital of Yunnan University
state: Yunnan
Study officials:
affiliation: Rizhao People's Hospital
name: JUN DONG, Associate chief physician
role: PRINCIPAL_INVESTIGATOR
References: