Carotid Artery StenosisNCT06936189
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)
An observational study of Carotid Artery Stenosis, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. at 1 site in China.
Trial summary
Purpose: To assess the long-term safety and efficacy of the intravascular lithotripsy system for pre-treatment of calcified carotid artery stenosis. Design: Prospective, multicenter, single-arm study with an extended follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Artery Stenosis
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2025to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients participating in this extended follow-up period are sourced from the registered clinical trial.
Who may be able to join
- All patients participating in this extended follow-up period are sourced from the registered clinical trial.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing
Xiaochuan Huo, 010-84005400, huoxiaochuan@126.com
About this study
Official title: A Prospective, Multicenter, Single-Arm Objective Performance Criteria Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Neurovascular Intravascular Shockwave Catheter and Intravascular Shockwave Therapy Device for Pretreatment of Calcified Lesions in the Extracranial Carotid Artery (CREATE Trial)） (Extended Follow-Up)
Purpose: To assess the long-term safety and efficacy of the intravascular lithotripsy system for pre-treatment of calcified carotid artery stenosis.
Design: Prospective, multicenter, single-arm study with an extended follow-up period.
Read more
Sample Size: 204 participants (based on the final number of cases enrolled in the registration trial).
Endpoints:
Primary: Surgical success rate (residual stenosis <30% after stenting). Secondary: Target lesion re-narrowing rate, target lesion revascularization rate, MAE rate, ipsilateral stroke rate, and MACCE rate at 3 and 6 months postoperatively.
Follow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively.
Inclusion criteria:
All patients participating in this extended follow-up period are sourced from the registered clinical trial.
Ethics and Consent: The trial will be conducted in accordance with the Helsinki Declaration and Chinese regulations. Informed consent will be obtained from all participants or their legal guardians.
Sponsor: Shanghai Lanfan Boyuan Medical Technology Co., Ltd. Principal Investigator: Professor Huo Xiaochuan, Beijing Anzhen Hospital.
Read the detailed description
### Detailed Description
This clinical trial evaluates the safety and long-term efficacy of a disposable neurovascular intravascular lithotripsy (IVL) catheter and intravascular lithotripsy treatment device for pre-treatment of calcified lesions in the extracranial segment of the carotid artery. The study is designed as a prospective, multicenter, single-arm trial （extended follow-up period）.
#### Study Population:
All patients participating in this extended follow-up period are sourced from the registered clinical trial.（The registered clinical trial:Participants aged 18-80 years with symptomatic (≥50%) or asymptomatic (≥70%) calcified carotid artery stenosis confirmed by CT angiography (CTA) and digital subtraction angiography (DSA) are eligible. Patients who have failed conventional balloon dilation and are planned for carotid artery stenting (CAS) will be included.）
#### Follow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively. Assessments will include clinical evaluations, imaging studies (CT angiography or carotid ultrasound), and recording of adverse events.
- Endpoints:
- Primary Endpoint: Surgical success rate defined as residual stenosis <30% after stenting.
- Secondary Endpoints: Target lesion re-narrowing rate, target lesion revascularization rate, MAE (major adverse events) rate, ipsilateral stroke rate, and MACCE (major adverse cardiovascular and cerebrovascular events) rate at 3 and 6 months postoperatively.
- Ethical Considerations:
Informed consent will be obtained from all participants or their legal guardians. The study will be conducted in accordance with the Helsinki Declaration and local regulatory requirements.
- Conditions
- Carotid Artery Stenosis
- Medical subject headings
- Carotid Stenosis
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 |
|---|---|---|
| Calcified Carotid Artery Stenosis Treated with IVL and Carotid Artery Stenting (CAS) | All patients participating in this extended follow-up period are sourced from the registered clinical trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion re-narrowing rate
Proportion of patients with ≥50% diameter stenosis at the target lesion, assessed by imaging at 3 and 6 months.
Measured: at 3 months and 6 months postoperatively
Secondary outcomes (4)
Target lesion revascularization rate
Incidence of repeat revascularization procedures at the treated lesion, evaluated at 3 and 6 months.
Measured: at 3 months and 6 months postoperatively
MAE (Major Adverse Events) rate
Rate of major adverse events (death, myocardial infarction, stroke) within 3 and 6 months.
Measured: at 3 months and 6 months postoperatively
Ipsilateral stroke rate
Incidence of stroke on the treated side, confirmed by clinical and imaging studies at 3 and 6 months.
Measured: at 3 months and 6 months postoperatively
MACCE (Major Adverse Cardio-Cerebrovascular Events) rate
Composite rate of death, stroke, myocardial infarction, and revascularization at 3 and 6 months.
Measured: at 3 months and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start12 May 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies 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
- Prospective
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936189
- Sponsor's protocol ID
- LFBY-202502
- Status last verified
- May 2025
- First submitted
- 12 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Objective Performance Criteria Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Neurovascular Intravascular Shockwave Catheter and Intravascular Shockwave Therapy Device for Pretreatment of Calcified Lesions in the Extracranial Carotid Artery (CREATE Trial)） (Extended Follow-Up)
- ClinicalTrials.gov ID
- NCT06936189
- Acronym / sponsor ID
- LFBY-202502
- Conditions
- Carotid Artery Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 May 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 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.
Purpose: To assess the long-term safety and efficacy of the intravascular lithotripsy system for pre-treatment of calcified carotid artery stenosis.
Design: Prospective, multicenter, single-arm study with an extended follow-up period.
Sample Size: 204 participants (based on the final number of cases enrolled in the registration trial).
Endpoints:
Primary: Surgical success rate (residual stenosis <30% after stenting). Secondary: Target lesion re-narrowing rate, target lesion revascularization rate, MAE rate, ipsilateral stroke rate, and MACCE rate at 3 and 6 months postoperatively.
Follow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively.
Inclusion criteria:
All patients participating in this extended follow-up period are sourced from the registered clinical trial.
Ethics and Consent: The trial will be conducted in accordance with the Helsinki Declaration and Chinese regulations. Informed consent will be obtained from all participants or their legal guardians.
Sponsor: Shanghai Lanfan Boyuan Medical Technology Co., Ltd. Principal Investigator: Professor Huo Xiaochuan, Beijing Anzhen Hospital.
Detailed description
### Detailed Description
This clinical trial evaluates the safety and long-term efficacy of a disposable neurovascular intravascular lithotripsy (IVL) catheter and intravascular lithotripsy treatment device for pre-treatment of calcified lesions in the extracranial segment of the carotid artery. The study is designed as a prospective, multicenter, single-arm trial （extended follow-up period）.
#### Study Population:
All patients participating in this extended follow-up period are sourced from the registered clinical trial.（The registered clinical trial:Participants aged 18-80 years with symptomatic (≥50%) or asymptomatic (≥70%) calcified carotid artery stenosis confirmed by CT angiography (CTA) and digital subtraction angiography (DSA) are eligible. Patients who have failed conventional balloon dilation and are planned for carotid artery stenting (CAS) will be included.）
#### Follow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively. Assessments will include clinical evaluations, imaging studies (CT angiography or carotid ultrasound), and recording of adverse events.
- Endpoints:
- Primary Endpoint: Surgical success rate defined as residual stenosis <30% after stenting.
- Secondary Endpoints: Target lesion re-narrowing rate, target lesion revascularization rate, MAE (major adverse events) rate, ipsilateral stroke rate, and MACCE (major adverse cardiovascular and cerebrovascular events) rate at 3 and 6 months postoperatively.
- Ethical Considerations:
Informed consent will be obtained from all participants or their legal guardians. The study will be conducted in accordance with the Helsinki Declaration and local regulatory requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Calcified Carotid Artery Stenosis Treated with IVL and Carotid Artery Stenting (CAS) | – | –All patients participating in this extended follow-up period are sourced from the registered clinical trial. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients participating in this extended follow-up period are sourced from the registered clinical trial.
Key inclusion criteria (1 listed)
- All patients participating in this extended follow-up period are sourced from the registered clinical trial.
Key exclusion criteria (1 listed)
- none
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
Target lesion re-narrowing rate
Time frame: at 3 months and 6 months postoperatively
Proportion of patients with ≥50% diameter stenosis at the target lesion, assessed by imaging at 3 and 6 months.
4 secondary outcomes
Target lesion revascularization rate
Time frame: at 3 months and 6 months postoperatively
MAE (Major Adverse Events) rate
Time frame: at 3 months and 6 months postoperatively
Ipsilateral stroke rate
Time frame: at 3 months and 6 months postoperatively
MACCE (Major Adverse Cardio-Cerebrovascular Events) rate
Time frame: at 3 months and 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. at 1 site 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 16 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaochuan Huo (010-64412431, huoxiaochuan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion re-narrowing rate (time frame: at 3 months and 6 months postoperatively). 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 16 May 2025.