StrokeNCT06917248
Evaluation of Clinical Effectiveness and Safety of Locaste 8F Guiding Catheter in Neurovascular Interventional Surgery
An observational study of Stroke and Hemorrhagic Strokes, run by Keuro MedTech at 2 sites in China.
Trial summary
The Locaste 8F Delivery Catheter by Kai MedTech has been launched in China since 2022 and has been widely used clinically. It won the government tendering in many provinces in China in early 2024. As a guiding and access device, the investigational device is used in interventional surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemorrhagic Strokes
- How many people
- 113 participants
- Where
- 2 sitesChina
- Study dates
- 21 May 2024to 7 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undertaken a neurovascular intervention surgery procedure including Locaste 8F Guiding Catheter in a reverse chronological order earlier than the date of the ethic approval.
Who may be able to join
- Age of 18 years or older;
- Undertaken a neurovascular surgery procedure including Locaste 8F Guiding Catheter;
- Available images of Locaste 8F Guiding Catheter in the neurovascular surgery;
Who cannot join
- Disorders of vascular fragility (e.g. Ehlers-Danlos syndrome)
- Prior vascular dissection or injury to vessels to be catheterized
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xinxiang City Central Hospital
Xinxiang, Henan, 453000
Zhumadian City Central Hospital
Zhumadian, Henan, 463000
About this study
The Locaste 8F Delivery Catheter by Kai MedTech has been launched in China since 2022 and has been widely used clinically. It won the government tendering in many provinces in China in early 2024. As a guiding and access device, the investigational device is used in interventional surgeries. The clinical investigation plans to conduct a non-interventional post-marketing real-world study to evaluate the safety and effectiveness of the product in clinical use. The investigator shall use the Locaste 8F Guiding Catheter according to his own surgery plan and the instruction for use (IFU) of this device. The large-bore guiding catheters (also called as long guiding sheath) by global manufacturers are generally used. Locaste 8F Guiding Catheter is marketed in China and widely accepted in clinical application. By collecting data in the real-world clinical routine treatment, the effectiveness and the safety of Locaste 8F Guiding Catheter is evaluated to provide data support of further global use of this device.
Read the detailed description
This clinical investigation is a single-arm, retrospective, multicenter clinical study of a medical device marketed in China. Patients with Locaste 8F Guiding Catheter used in the neurovascular interventional surgery and the surgery video of the Locaste 8F Guiding Catheter available are recruited in this study. The data on the surgery day and follow-up data within 24 hours after surgery are collected retrospectively.
This clinical investigation will be performed in accordance with the Declaration of Helsinki [5] and the applicable parts of ISO 14155：2020 Clinical investigation of medical devices for human subjects - Good clinical practice made by International Organization for Standardization except for section 5.8 informed consent and other non-relevant aspects for retrospective study. The ethic approval was achieved with the exemption of informed consent according to the local China regulations "The Guidelines for the Establishment of Ethical Review Committees for Clinical Research Involving Humans", article 5 Exemption of Informed consent.
Since this clinical investigation is a non-interventional post-market study with the intended use of the investigational device in China, this study does not apply to the scope of pre-market clinical investigation for medical device approval defined in the Medical Device Good Clinical Practice (2022) issued by the China NMPA . Thus, this clinical investigation only refers to the applicable part of the Medical Device Good Clinical Practice (2022) issued by the China NMPA.
Given the fact that this clinical investigation is a retrospective study, any serious adverse event (SAE) should have been reported according to the regulation Procedure for Monitoring and Re-evaluation of Medical Device Adverse Event (2018). No serious adverse events in this study shall be reported again. In case of any underreporting, the investigator shall report the serious adverse events according to the Procedure for Monitoring and Re-evaluation of Medical Device Adverse Event (2018).
The intended use of the investigational device approved in China is that "The device is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature". The subject cohort in this clinical investigation is covered by the device use scope.
- Conditions
- Stroke, Hemorrhagic Strokes
- Keywords
- Locaste, Long sheath, Guiding catheter
- Medical subject headings
- Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Locaste 8F Guiding Catheter in Neurovascular interventional surgery | Patients with Locaste 8F Guiding Catheter used in the neurovascular interventional surgery and the surgery video of the Locaste 8F Guiding Catheter available are recruited in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Success Rate
Definition：Number of Patients with Device Success / Number of Recruited Patients * 100% Device Success： Use 5-Point Likert Scale to evaluate the navigability of device to the targeted vessel position.
- Unsatisfactory；
- Unacceptable；
- Adequate；
- Good;
- Excellent； Device success is defined as the score ≥3.
Measured: Day 0 （During surgery）
Secondary outcomes (5)
Ability to deliver other interventional devices
Definition：the incidence of score ≥3: Ability to deliver other interventional devices is defined the satisfactory rate of the ability to deliver other interventional devices. Use 5-Point Likert Scale to evaluate the ability to deliver other interventional devices.
- Unsatisfactory；
- Unacceptable；
- Adequate；
- Good；
- Excellent；
Measured: Day 0（During surgery）
Visibility under X-ray
Definition：Visibility under X-ray: the incidence of score ≥3； Visibility under X-ray is defined as the satisfactory rate of the visibility under X-ray. Use 5-Point Likert Scale to evaluate the Visibility under X-ray.
- Unsatisfactory；
- Unacceptable；
- Adequate；
- Good；
- Excellent；
Measured: Day 0（During surgery）
Ability to support other interventional devices
The incidence to achieve satisfactory support of other interventional devices.
Measured: Day 0（During surgery）
Device Deficiency
For all the subjects who have completed the surgery, no defects of the investigational device were found. One patient did not complete the surgery and no defects of the investigational device were found during the use.
Measured: Day 0 (During surgery)
Adverse Event (AE)
For all the subjects who have completed the surgery, no adverse events were found. One patient did not complete the surgery and no adverse events were found during the use.
Measured: Day 0(during surgery) or Day 1 (within 24 hours after the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start21 May 2024
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keuro MedTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917248
- Sponsor's protocol ID
- CIP-PICA-RWD
- Status last verified
- Jun 2025
- First submitted
- 21 Mar 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Effectiveness and Safety of Locaste 8F Guiding Catheter in Neurovascular Interventional Surgery
- ClinicalTrials.gov ID
- NCT06917248
- Acronym / sponsor ID
- CIP-PICA-RWD
- Conditions
- Stroke, Hemorrhagic Strokes
- Keywords
- Locaste, Long sheath, Guiding catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Keuro MedTechIndustry (pharma, biotech, devices)
- Study start
- 21 May 2024 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 8 Apr 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 Locaste 8F Delivery Catheter by Kai MedTech has been launched in China since 2022 and has been widely used clinically. It won the government tendering in many provinces in China in early 2024. As a guiding and access device, the investigational device is used in interventional surgeries. The clinical investigation plans to conduct a non-interventional post-marketing real-world study to evaluate the safety and effectiveness of the product in clinical use. The investigator shall use the Locaste 8F Guiding Catheter according to his own surgery plan and the instruction for use (IFU) of this device. The large-bore guiding catheters (also called as long guiding sheath) by global manufacturers are generally used. Locaste 8F Guiding Catheter is marketed in China and widely accepted in clinical application. By collecting data in the real-world clinical routine treatment, the effectiveness and the safety of Locaste 8F Guiding Catheter is evaluated to provide data support of further global use of this device.
Detailed description
This clinical investigation is a single-arm, retrospective, multicenter clinical study of a medical device marketed in China. Patients with Locaste 8F Guiding Catheter used in the neurovascular interventional surgery and the surgery video of the Locaste 8F Guiding Catheter available are recruited in this study. The data on the surgery day and follow-up data within 24 hours after surgery are collected retrospectively.
This clinical investigation will be performed in accordance with the Declaration of Helsinki [5] and the applicable parts of ISO 14155：2020 Clinical investigation of medical devices for human subjects - Good clinical practice made by International Organization for Standardization except for section 5.8 informed consent and other non-relevant aspects for retrospective study. The ethic approval was achieved with the exemption of informed consent according to the local China regulations "The Guidelines for the Establishment of Ethical Review Committees for Clinical Research Involving Humans", article 5 Exemption of Informed consent.
Since this clinical investigation is a non-interventional post-market study with the intended use of the investigational device in China, this study does not apply to the scope of pre-market clinical investigation for medical device approval defined in the Medical Device Good Clinical Practice (2022) issued by the China NMPA . Thus, this clinical investigation only refers to the applicable part of the Medical Device Good Clinical Practice (2022) issued by the China NMPA.
Given the fact that this clinical investigation is a retrospective study, any serious adverse event (SAE) should have been reported according to the regulation Procedure for Monitoring and Re-evaluation of Medical Device Adverse Event (2018). No serious adverse events in this study shall be reported again. In case of any underreporting, the investigator shall report the serious adverse events according to the Procedure for Monitoring and Re-evaluation of Medical Device Adverse Event (2018).
The intended use of the investigational device approved in China is that "The device is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature". The subject cohort in this clinical investigation is covered by the device use scope.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locaste 8F Guiding Catheter in Neurovascular interventional surgery | – | –Patients with Locaste 8F Guiding Catheter used in the neurovascular interventional surgery and the surgery video of the Locaste 8F Guiding Catheter available are recruited in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undertaken a neurovascular intervention surgery procedure including Locaste 8F Guiding Catheter in a reverse chronological order earlier than the date of the ethic approval.
Key inclusion criteria (3 listed)
- Age of 18 years or older;
- Undertaken a neurovascular surgery procedure including Locaste 8F Guiding Catheter;
- Available images of Locaste 8F Guiding Catheter in the neurovascular surgery;
Key exclusion criteria (2 listed)
- Disorders of vascular fragility (e.g. Ehlers-Danlos syndrome)
- Prior vascular dissection or injury to vessels to be catheterized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device Success Rate
Time frame: Day 0 （During surgery）
Definition：Number of Patients with Device Success / Number of Recruited Patients * 100% Device Success： Use 5-Point Likert Scale to evaluate the navigability of device to the targeted vessel position. 1. Unsatisfactory； 2. Unacceptable； 3. Adequate； 4. Good; 5. Excellent； Device success is defined as the score ≥3.
5 secondary outcomes
Ability to deliver other interventional devices
Time frame: Day 0（During surgery）
Visibility under X-ray
Time frame: Day 0（During surgery）
Ability to support other interventional devices
Time frame: Day 0（During surgery）
Device Deficiency
Time frame: Day 0 (During surgery)
Adverse Event (AE)
Time frame: Day 0(during surgery) or Day 1 (within 24 hours after the surgery)
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 24 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hemorrhagic Strokes, run by Keuro MedTech at 2 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 2 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Device Success Rate (time frame: Day 0 （During surgery）). 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 24 Jun 2025.