Acute Ischemic StrokeNCT06989931
Intracranial Distal Access Catheter in Neurointerventional Therapy
An observational study of Acute Ischemic Stroke and Intracranial Aneurysms, run by MicroPort NeuroTech Co., Ltd. at 6 sites in China.
Trial summary
The study objective is to evaluate the safety and effectiveness of Intracranial Distal Access Catheter in neurointerventional therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke, Intracranial Aneurysms
- What is being tested?
- Intracranial Distal Access Catheter
- Type of treatment
- Medical device
- How many people
- 114 participants
- Where
- 6 sitesChina
- Study dates
- 7 Dec 2023to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.)
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Jiangmen Xinhui District People's Hospital
Jiangmen, Guangdong
The Affiliated Hospital of Yunnan University
Kunming, Yunnan
The Sixth People's Hospital of Nantong
Nantong, Jiangsu
People's Hospital of Rizhao
Rizhao, Shandong
Xinxiang Central Hospital
Xinxiang, Henan
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian
About this study
Official title: A Clinical Study on the Safety and Effectiveness of 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke, Intracranial Aneurysms
- Being tested
- Intracranial Distal Access Catheter
- Medical subject headings
- Ischemic Stroke, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial Distal Access CatheterDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: Device: Intracranial Distal Access Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: immediately after procedure
Secondary outcomes (3)
Catheter delivery success rate
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%
Measured: immediately after procedure
Incidence of device-related adverse events
Measured: from the procedure to patients discharged from the hospital, anticipated average 5 days
Incidence of device-related serious adverse events
Measured: from the procedure to patients discharged from the hospital, anticipated average 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start7 Dec 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Happy Life Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- JUN DONG, Associate chief physician, Principal investigator, Rizhao People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989931
- Sponsor's protocol ID
- STA-2023-01-0A
- Status last verified
- May 2025
- First submitted
- 15 Apr 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Effectiveness of Intracranial Distal Access Catheter in Neurointerventional Therapy
- ClinicalTrials.gov ID
- NCT06989931
- Acronym / sponsor ID
- STA-2023-01-0A
- Conditions
- Acute Ischemic Stroke, Intracranial Aneurysms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tianjin Happy Life Technology Co., Ltd.
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who using the Intracranial Distal Access Catheter to complete the procedure | – | Device: Intracranial Distal Access CatheterPatients 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.) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.)
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracranial Distal Access CatheterPatients 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 | Device | Subjects who using the Intracranial Distal Access Catheter to complete the procedure |
Primary outcome
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%
3 secondary outcomes
Catheter delivery success rate
Time frame: immediately after procedure
Incidence of device-related adverse events
Time frame: from the procedure to patients discharged from the hospital, anticipated average 5 days
Incidence of device-related serious adverse events
Time frame: from the procedure to patients discharged from the hospital, anticipated average 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JUN DONG, Associate chief physician principal investigator
Rizhao People's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Intracranial Aneurysms, run by MicroPort NeuroTech Co., Ltd. at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate (time frame: immediately after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.