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NCT Number: NCT06989931

Intracranial Distal Access Catheter in Neurointerventional Therapy

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

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Key information

Conditions

Acute Ischemic Stroke Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Aneurysms Intracranial Arterial Diseases Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhangzhou Municipal Hospital of Fujian Province, Zhangzhou, Fujian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Technical success rate

    Time frame: 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 outcomes

  1. Catheter delivery success rate

    Time frame: 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%

  2. Incidence of device-related adverse events

    Time frame: from the procedure to patients discharged from the hospital, anticipated average 5 days

  3. Incidence of device-related serious adverse events

    Time frame: from the procedure to patients discharged from the hospital, anticipated average 5 days

Other outcomes

  1. Device operation performance (device compatibility)

    Time frame: 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

  2. Device operation performance (supporting capability)

    Time frame: 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.

  3. Device operation performance (pushing resistance)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

MicroPort NeuroTech Co., Ltd.

Industry

Collaborators

  • Tianjin Happy Life Technology Co., Ltd.

Registry information

Official study title

A Clinical Study on the Safety and Effectiveness of Intracranial Distal Access Catheter in Neurointerventional Therapy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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