Intracranial Distal Access Catheter in Neurointerventional Therapy

NCT06989931 | Completed

• 1 other identifier: STA-2023-01-0A
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Acute Ischemic Stroke; Intracranial Aneurysms

Outcome Measures

Primary Outcomes (1)

• 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%

  immediately after procedure

Secondary Outcomes (3)

• Catheter delivery success rate

  immediately after procedure

• 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 Outcomes (3)

• Device operation performance (device compatibility)

  intra-procedure

• Device operation performance (supporting capability)

  intra-procedure

• Device operation performance (pushing resistance)

  intra-procedure

Study Arms (1)

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.)

Device: Intracranial Distal Access Catheter

Interventions

Intracranial Distal Access Catheter 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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• MicroPort NeuroTech Co., Ltd.: lead
• Tianjin Happy Life Technology Co., Ltd.: collaborator

Study Sites (6)

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

Location

Jiangmen Xinhui District People's Hospital

Jiangmen, Guangdong, China

Location

Xinxiang Central Hospital

Xinxiang, Henan, China

Location

The Sixth People's Hospital of Nantong

Nantong, Jiangsu, China

Location

People's Hospital of Rizhao

Rizhao, Shandong, China

Location

The Affiliated Hospital of Yunnan University

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm

Study Officials

• JUN DONG, Associate chief physician

  Rizhao People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 25, 2025
• Study Start: December 7, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

CN (6)