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New treatment option for Carotid Artery Stenosis
Official title Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)
ClinicalTrials.gov ID: NCT06936176
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Intraoperative digital subtraction angiography (DSA) confirms carotid stenosis ≥50% (by NASCET criteria) or asymptomatic carotid stenosis ≥70% (by...
- Participants with a pre-enrollment modified Rankin Scale (mRS) score ≤2.
- Participants planned for carotid artery stenting (CAS) who have failed conventional balloon dilation.
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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.
- 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 \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.