Carotid Artery StenosisCREATENCT06936176
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)
A study testing Neurovascular Intravascular Shockwave Catheter in people with Carotid Artery Stenosis, run by Shanghai Bluesail Boyuan Medical Technology Co., Ltd. at 1 site in China.
Trial summary
Clinical Trial Summary Trial Title:** CREATE Trial: Safety and Efficacy of IVL for Carotid Calcified Lesions Sponsor:** Shanghai Bluesail Boyuan Medical Technology Co., Ltd. Clinical Trial Leader:** Beijing Anzhen Hospital Coordinating Investigator:** Prof. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Neurovascular Intravascular Shockwave Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2025to 30 Dec 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age 18-80 years (inclusive), gender unrestricted.
- Extracranial carotid artery: Preoperative CT angiography (CTA) confirms symptomatic carotid stenosis ≥50% or asymptomatic carotid stenosis ≥70% with calcification (CTA measurement: calcification > 50% of circumference).
- Note: (Extracranial carotid artery: Internal carotid artery or carotid bifurcation; Symptomatic refers to having had a non-disabling ischemic stroke or TIA within 6 months.)
- Intraoperative digital subtraction angiography (DSA) confirms carotid stenosis ≥50% (by NASCET criteria) or asymptomatic carotid stenosis ≥70% (by NASCET criteria).
- Participants with a pre-enrollment modified Rankin Scale (mRS) score ≤2.
- Participants planned for carotid artery stenting (CAS) who have failed conventional balloon dilation.
- Patients or their legal guardians understand the purpose of the trial, provide informed consent, and agree to follow-up.
Who cannot join
- Target lesion caused by non-atherosclerotic disease.
- Participants with complete occlusion of the target lesion or contralateral carotid artery.
- Participants with severe disability due to cerebral infarction.
- Participants with large acute or subacute thrombi near the target lesion, or with arteriovenous malformations or aneurysms.
- Participants with tortuous target lesion vessels that prevent stent placement.
- Participants with symptomatic severe stenosis in other cerebral vessels.
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- Participants requiring concurrent or additional surgical interventions during the trial period.
- Participants with tandem severe stenosis or occlusion in vessels proximal or distal to the target lesion.
- Participants who have had a myocardial infarction or large cerebral infarction within 2 weeks prior to screening.
- Participants who have had intracranial hemorrhage within 3 months prior to screening.
- Participants with vulnerable or high-risk plaques (unstable, prone to rupture, and thrombosis leading to acute cardiovascular events or death) as judged by carotid ultrasound.
- Participants with uncontrolled hypertension (systolic blood pressure persistently ≥180 mmHg or diastolic blood pressure persistently ≥110 mmHg).
- Participants with known platelet count < 90×10^9/L, severe liver impairment (transaminases > 3 times the upper limit of normal), severe renal impairment (serum creatinine > 2.5 mg/dL [221 µmol/L]), or New York Heart Association Class IV heart failure.
- Participants with coagulopathy (INR ≥2.0) or contraindications to heparin or antiplatelet agents.
- Participants with active infections.
- Participants unable to use cerebral protection devices.
- Participants allergic to components of the investigational device or contrast agents (excluding rash).
- Participants with life expectancy less than 1 year.
- Pregnant or breastfeeding women.
- Participants currently enrolled in another drug or medical device clinical trial (before reaching the primary endpoint).
- Other situations where the investigator deems the participant unsuitable for the trial.
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 An Zhen Hospital of the Capital University of Medical Sciences
Beijing
Xiaochuan Huo, 010-64412431, 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)）
- Clinical Trial Summary
- Trial Title:** CREATE Trial: Safety and Efficacy of IVL for Carotid Calcified Lesions
- Sponsor:** Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Clinical Trial Leader:** Beijing Anzhen Hospital
- Coordinating Investigator:** Prof. Huo Xiaochuan
- Study Purpose This trial assesses a new device-a single-use neurovascular intravascular shockwave catheter and therapy device-for treating calcified blockages in the carotid artery. It uses sound waves to break up calcium deposits, facilitating stent placement and blood flow restoration.
- Eligibility
- Adults aged 18-80 with severe carotid artery narrowing (≥50% symptomatic or ≥70% asymptomatic) due to calcium buildup.
- Patients who failed standard balloon dilation.
- Exclusions include pregnancy, recent strokes/heart attacks, uncontrolled hypertension, or other high-risk conditions.
- Study Design
- Type: Prospective, multicenter, single-arm trial.
- Sample Size: 204 patients across multiple hospitals.
- Duration: 1-month follow-up post-procedure.
- Procedures
- Pre-treatment: Imaging (CT angiography, ultrasound) to confirm eligibility.
- Procedure: Shockwave catheter breaks up calcium, followed by stent placement.
- Follow-up: Assessments at 7 days (or discharge) and 1 month post-procedure.
Read more
- Benefits and Risks
- Benefits: Improved stent placement success, reduced risk of complications, minimally invasive with shorter recovery time.
- Risks: Bleeding, infection, vessel damage, stroke, heart attack, device malfunction. Risks are closely monitored with emergency protocols.
- Patient Protections
- Ethics committee approval and strict safety guidelines.
- Voluntary participation with the option to withdraw anytime.
- Free treatment and compensation for trial-related injuries.
- For Healthcare Providers
- Innovation: Adapts coronary lithotripsy technology for carotid use.
- Evidence: Supported by preclinical data and a pilot study (100% success rate in 5 patients).
- Endpoints: Primary: Stent success (residual stenosis <30%) and 30-day major adverse events. Secondary: Device success rate, repeat procedures, long-term outcomes.
- Contact Information
For questions, contact:
Ms. Zhang Yanjiao Email: yanjiao.zhang@jwmsgrp.com
Read the detailed description
Detailed Clinical Trial Description
### 1. Background and Rationale Clinical Need:
- Carotid artery calcification is a major contributor to ischemic stroke, accounting for 15-20% of cases. Severe calcification complicates stent placement, leading to high rates of residual stenosis and adverse events (e.g., stroke, myocardial infarction) with conventional treatments like balloon angioplasty.
- Current Limitations: Standard therapies often fail to adequately modify calcified plaques, necessitating high-pressure balloon dilation, which risks embolization, vessel dissection, or hemodynamic instability.
Innovative Solution:
- The intravascular lithotripsy (IVL) system delivers localized sonic pressure waves to fracture calcium deposits while sparing soft tissue, enabling safer stent deployment.
- Evidence Base: Supported by coronary IVL trials (e.g., DISRUPT CAD I-IV) and off-label carotid case reports demonstrating 90-100% technical success with minimal complications. ### 2. Study Objectives Primary Objectives:
- Efficacy: Assess surgical success rate (stent placement with residual stenosis <30%).
- Safety: Evaluate 30-day major adverse events (MAE) (composite of death, stroke, or myocardial infarction).
Secondary Objectives:
- Device success rate (successful delivery/retrieval of IVL catheter).
- Rates of target lesion revascularization, ipsilateral stroke, and MACCE (major adverse cardiac/cerebrovascular events). ### 3. Methodology Study Design:
- Prospective, multicenter, single-arm, objective performance criteria (OPC) trial.
- No control group due to ethical concerns (standard therapy failure is an inclusion criterion).
Intervention:
- IVL Catheter: Rapid-exchange balloon catheter with integrated electrodes generating sonic waves (80 pulses max per device).
- IVL Device: Console delivering controlled energy pulses (compatible with 3.0-5.0 mm balloons).
Procedure Steps:
- Pre-treatment: Dual antiplatelet therapy (aspirin + clopidogrel) for ≥3 days.
- IVL Delivery:
- Balloon inflation to 6 atm, followed by 10 pulses/cycle (up to 8 cycles).
- Stent placement post-calcium modification.
- Post-procedure: Monitoring for MAE at 7 days and 1 month.
Key Assessments:
- Imaging: CT angiography (baseline), DSA (intraoperative), ultrasound (follow-up).
- Clinical: NIHSS/mRS scores, vital signs, lab tests (hematology, biochemistry).
- 4. Participant Selection Inclusion Criteria:
- Symptomatic (≥50%) or asymptomatic (≥70%) carotid stenosis with circumferential calcium >50% (CTA-confirmed).
- Failed conventional balloon pre-dilation (residual stenosis >70%).
- Modified Rankin Scale (mRS) score ≤2.
Exclusion Criteria:
- Vulnerable plaques, recent stroke/MI (within 2-12 weeks), or contraindications to antiplatelets.
- Severe comorbidities (e.g., NYHA Class IV heart failure, creatinine >2.5 mg/dL). ### 5. Risk Management Anticipated Risks:
- Procedure-related: Vessel dissection (1-3%), embolic stroke (2-5%), access-site hematoma.
- Device-related: Balloon rupture, electrode malfunction (<1%).
Mitigation Strategies:
- Embolic protection devices mandatory.
- Strict operator training (≥5 supervised cases required).
- Real-time monitoring for hemodynamic instability (bradycardia/hypotension). ### 6. Statistical Plan Sample Size Justification:
- Efficacy endpoint: 107 patients needed (95% expected vs. 85% OPC, α=0.025, power=90%).
- Safety endpoint: 204 patients (4.5% expected vs. 11% OPC).
- Total: 204 (accounting for 10% dropout).
Analysis Populations:
- Full Analysis Set (FAS): All treated patients (intent-to-treat).
- Per-Protocol Set (PPS): Excludes major protocol deviations.
Statistical Tests:
- Primary endpoints: One-sided 95% CI (success rate lower bound >85%; MAE upper bound <11%).
- Secondary endpoints: Descriptive statistics (rates, Kaplan-Meier survival analysis). ### 7. Ethical and Regulatory Compliance
- Ethics Approval: Obtained from all site IRBs (reference: LFBY-202501).
- Informed Consent: Mandatory, with provisions for legally authorized representatives.
- Data Protection: Compliant with China's Personal Information Protection Law (PIPL). ### 8. Operational Oversight
- Monitoring: Centralized EDC (Medidata Rave) with 100% source data verification.
- Audits: Independent DSMB reviews safety data biannually.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Neurovascular Intravascular Shockwave Catheter
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurovascular Intravascular Shockwave CatheterDevice
Device:
Neurovascular Intravascular Shockwave Catheter (single-use, rapid-exchange balloon catheter with integrated shockwave emitters).
Intravascular Shockwave Therapy Device (IVL-HVG-N01, generates localized shockwaves to fracture calcifications).
Procedure:
Patients undergo standard CAS preparation with guidewire placement and cerebral protection.
If conventional balloon angioplasty fails (residual stenosis >70%), the IVL catheter is advanced to the target lesion.
Shockwave therapy is applied at 6 atm, followed by low-pressure balloon dilation (8 atm) if needed.
Subsequent stent deployment is performed per standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Patients with calcified extracranial carotid artery stenosis | Experimental | Study Arm: Single-arm, prospective, multicenter trial evaluating the safety and efficacy of the Neurovascular Intravascular Shockwave Catheter and Intravascular Shockwave Therapy Device for pretreatment of calcified lesions in the extracranial carotid artery prior to carotid artery stenting (CAS). Receives: Device: Neurovascular Intravascular Shockwave Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success Rate
Successful stent deployment with residual stenosis <30% after the procedure (via angiography).
Measured: Immediately post-procedure (intraoperative).
30-Day Major Adverse Events (MAE) Rate
Composite of:
All-cause death； Stroke (ischemic or hemorrhagic, with neurological deficits lasting ≥24h)； Myocardial infarction (MI) (per standard diagnostic criteria).
Measured: 30 days (±7 days) post-procedure.
Secondary outcomes (5)
Device Success
Successful delivery, activation, and retrieval of the neurovascular intravascular shockwave (IVL) catheter without technical failure.
Measured: Intraoperative
Device Malfunction Rate
The Device Malfunction Rate is the percentage of procedures where the IVL catheter or device fails to operate as intended, including issues like balloon rupture or electrode malfunction.
Measured: Intraoperative
Target Lesion Revascularization Rate
The incidence of revascularization treatment for the initially treated lesion vessel after surgery.
Measured: Within 7 days/Before Discharge, 1 Month Postoperative
Ipsilateral Stroke Rate
The occurrence of a stroke event on the same side as the target vessel in the subject.
Measured: Within 7 days/Before Discharge, 1 Month Postoperative
Major Adverse Cardio-Cerebrovascular Events (MACCE) Rate
A composite of all-cause death, any stroke, any myocardial infarction, and any revascularization.
Measured: Within 7 days/Before Discharge, 1 Month Postoperative
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT06936176
- Sponsor's protocol ID
- LFBY-202501
- Acronym
- CREATE
- Status last verified
- May 2025
- First submitted
- 12 Apr 2025
- Last updated
- 16 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 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)）
- ClinicalTrials.gov ID
- NCT06936176
- Acronym / sponsor ID
- CREATE / LFBY-202501
- Conditions
- Carotid Artery Stenosis
- Study type
- Interventional
- 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.
- Clinical Trial Summary
- Trial Title:** CREATE Trial: Safety and Efficacy of IVL for Carotid Calcified Lesions
- Sponsor:** Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Clinical Trial Leader:** Beijing Anzhen Hospital
- Coordinating Investigator:** Prof. Huo Xiaochuan
- Study Purpose This trial assesses a new device-a single-use neurovascular intravascular shockwave catheter and therapy device-for treating calcified blockages in the carotid artery. It uses sound waves to break up calcium deposits, facilitating stent placement and blood flow restoration.
- Eligibility
- Adults aged 18-80 with severe carotid artery narrowing (≥50% symptomatic or ≥70% asymptomatic) due to calcium buildup.
- Patients who failed standard balloon dilation.
- Exclusions include pregnancy, recent strokes/heart attacks, uncontrolled hypertension, or other high-risk conditions.
- Study Design
- Type: Prospective, multicenter, single-arm trial.
- Sample Size: 204 patients across multiple hospitals.
- Duration: 1-month follow-up post-procedure.
- Procedures
- Pre-treatment: Imaging (CT angiography, ultrasound) to confirm eligibility.
- Procedure: Shockwave catheter breaks up calcium, followed by stent placement.
- Follow-up: Assessments at 7 days (or discharge) and 1 month post-procedure.
- Benefits and Risks
- Benefits: Improved stent placement success, reduced risk of complications, minimally invasive with shorter recovery time.
- Risks: Bleeding, infection, vessel damage, stroke, heart attack, device malfunction. Risks are closely monitored with emergency protocols.
- Patient Protections
- Ethics committee approval and strict safety guidelines.
- Voluntary participation with the option to withdraw anytime.
- Free treatment and compensation for trial-related injuries.
- For Healthcare Providers
- Innovation: Adapts coronary lithotripsy technology for carotid use.
- Evidence: Supported by preclinical data and a pilot study (100% success rate in 5 patients).
- Endpoints: Primary: Stent success (residual stenosis <30%) and 30-day major adverse events. Secondary: Device success rate, repeat procedures, long-term outcomes.
- Contact Information
For questions, contact:
Ms. Zhang Yanjiao Email: yanjiao.zhang@jwmsgrp.com
Detailed description
Detailed Clinical Trial Description
### 1. Background and Rationale Clinical Need:
- Carotid artery calcification is a major contributor to ischemic stroke, accounting for 15-20% of cases. Severe calcification complicates stent placement, leading to high rates of residual stenosis and adverse events (e.g., stroke, myocardial infarction) with conventional treatments like balloon angioplasty.
- Current Limitations: Standard therapies often fail to adequately modify calcified plaques, necessitating high-pressure balloon dilation, which risks embolization, vessel dissection, or hemodynamic instability.
Innovative Solution:
- The intravascular lithotripsy (IVL) system delivers localized sonic pressure waves to fracture calcium deposits while sparing soft tissue, enabling safer stent deployment.
- Evidence Base: Supported by coronary IVL trials (e.g., DISRUPT CAD I-IV) and off-label carotid case reports demonstrating 90-100% technical success with minimal complications. ### 2. Study Objectives Primary Objectives:
- Efficacy: Assess surgical success rate (stent placement with residual stenosis <30%).
- Safety: Evaluate 30-day major adverse events (MAE) (composite of death, stroke, or myocardial infarction).
Secondary Objectives:
- Device success rate (successful delivery/retrieval of IVL catheter).
- Rates of target lesion revascularization, ipsilateral stroke, and MACCE (major adverse cardiac/cerebrovascular events). ### 3. Methodology Study Design:
- Prospective, multicenter, single-arm, objective performance criteria (OPC) trial.
- No control group due to ethical concerns (standard therapy failure is an inclusion criterion).
Intervention:
- IVL Catheter: Rapid-exchange balloon catheter with integrated electrodes generating sonic waves (80 pulses max per device).
- IVL Device: Console delivering controlled energy pulses (compatible with 3.0-5.0 mm balloons).
Procedure Steps:
- Pre-treatment: Dual antiplatelet therapy (aspirin + clopidogrel) for ≥3 days.
- IVL Delivery:
- Balloon inflation to 6 atm, followed by 10 pulses/cycle (up to 8 cycles).
- Stent placement post-calcium modification.
- Post-procedure: Monitoring for MAE at 7 days and 1 month.
Key Assessments:
- Imaging: CT angiography (baseline), DSA (intraoperative), ultrasound (follow-up).
- Clinical: NIHSS/mRS scores, vital signs, lab tests (hematology, biochemistry).
- 4. Participant Selection Inclusion Criteria:
- Symptomatic (≥50%) or asymptomatic (≥70%) carotid stenosis with circumferential calcium >50% (CTA-confirmed).
- Failed conventional balloon pre-dilation (residual stenosis >70%).
- Modified Rankin Scale (mRS) score ≤2.
Exclusion Criteria:
- Vulnerable plaques, recent stroke/MI (within 2-12 weeks), or contraindications to antiplatelets.
- Severe comorbidities (e.g., NYHA Class IV heart failure, creatinine >2.5 mg/dL). ### 5. Risk Management Anticipated Risks:
- Procedure-related: Vessel dissection (1-3%), embolic stroke (2-5%), access-site hematoma.
- Device-related: Balloon rupture, electrode malfunction (<1%).
Mitigation Strategies:
- Embolic protection devices mandatory.
- Strict operator training (≥5 supervised cases required).
- Real-time monitoring for hemodynamic instability (bradycardia/hypotension). ### 6. Statistical Plan Sample Size Justification:
- Efficacy endpoint: 107 patients needed (95% expected vs. 85% OPC, α=0.025, power=90%).
- Safety endpoint: 204 patients (4.5% expected vs. 11% OPC).
- Total: 204 (accounting for 10% dropout).
Analysis Populations:
- Full Analysis Set (FAS): All treated patients (intent-to-treat).
- Per-Protocol Set (PPS): Excludes major protocol deviations.
Statistical Tests:
- Primary endpoints: One-sided 95% CI (success rate lower bound >85%; MAE upper bound <11%).
- Secondary endpoints: Descriptive statistics (rates, Kaplan-Meier survival analysis). ### 7. Ethical and Regulatory Compliance
- Ethics Approval: Obtained from all site IRBs (reference: LFBY-202501).
- Informed Consent: Mandatory, with provisions for legally authorized representatives.
- Data Protection: Compliant with China's Personal Information Protection Law (PIPL). ### 8. Operational Oversight
- Monitoring: Centralized EDC (Medidata Rave) with 100% source data verification.
- Audits: Independent DSMB reviews safety data biannually.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with calcified extracranial carotid artery stenosis | Experimental | Device: Neurovascular Intravascular Shockwave CatheterStudy Arm: Single-arm, prospective, multicenter trial evaluating the safety and efficacy of the Neurovascular Intravascular Shockwave Catheter and Intravascular Shockwave Therapy Device for pretreatment of calcified lesions in the extracranial carotid artery prior to carotid artery stenting (CAS). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-80 years (inclusive), gender unrestricted.
- Extracranial carotid artery: Preoperative CT angiography (CTA) confirms symptomatic carotid stenosis ≥50% or asymptomatic carotid stenosis ≥70% with calcification (CTA measurement: calcification > 50% of circumference).
- Note: (Extracranial carotid artery: Internal carotid artery or carotid bifurcation; Symptomatic refers to having had a non-disabling ischemic stroke or TIA within 6 months.)
- Intraoperative digital subtraction angiography (DSA) confirms carotid stenosis ≥50% (by NASCET criteria) or asymptomatic carotid stenosis ≥70% (by NASCET criteria).
- Participants with a pre-enrollment modified Rankin Scale (mRS) score ≤2.
Key exclusion criteria (21 listed)
- Target lesion caused by non-atherosclerotic disease.
- Participants with complete occlusion of the target lesion or contralateral carotid artery.
- Participants with severe disability due to cerebral infarction.
- Participants with large acute or subacute thrombi near the target lesion, or with arteriovenous malformations or aneurysms.
- Participants with tortuous target lesion vessels that prevent stent placement.
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 |
|---|---|---|
| Neurovascular Intravascular Shockwave CatheterDevice: Neurovascular Intravascular Shockwave Catheter (single-use, rapid-exchange balloon catheter with integrated shockwave emitters). Intravascular Shockwave Therapy Device (IVL-HVG-N01, generates localized shockwaves to fracture calcifications). Procedure: Patients undergo standard CAS preparation with guidewire placement and cerebral protection. If conventional balloon angioplasty fails (residual stenosis >70%), the IVL catheter is advanced to the target lesion. Shockwave therapy is applied at 6 atm, followed by low-pressure balloon dilation (8 atm) if needed. Subsequent stent deployment is performed per standard practice. | Device | Patients with calcified extracranial carotid artery stenosis |
Primary outcome
Procedural Success Rate
Time frame: Immediately post-procedure (intraoperative).
Successful stent deployment with residual stenosis <30% after the procedure (via angiography).
30-Day Major Adverse Events (MAE) Rate
Time frame: 30 days (±7 days) post-procedure.
Composite of: All-cause death； Stroke (ischemic or hemorrhagic, with neurological deficits lasting ≥24h)； Myocardial infarction (MI) (per standard diagnostic criteria).
5 secondary outcomes
Device Success
Time frame: Intraoperative
Device Malfunction Rate
Time frame: Intraoperative
Target Lesion Revascularization Rate
Time frame: Within 7 days/Before Discharge, 1 Month Postoperative
Ipsilateral Stroke Rate
Time frame: Within 7 days/Before Discharge, 1 Month Postoperative
Major Adverse Cardio-Cerebrovascular Events (MACCE) Rate
Time frame: Within 7 days/Before Discharge, 1 Month Postoperative
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.
Beijing An Zhen Hospital of the Capital University of Medical Sciences
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurovascular Intravascular Shockwave Catheter in people with 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 7 inclusion and 21 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success Rate (time frame: Immediately post-procedure (intraoperative).). The study lists 2 primary outcomes in all. 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.