Status:
RECRUITING
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)
Lead Sponsor:
Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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. * Clinica...
Detailed Description
\*\*Detailed Clinical Trial Description\*\* \### \*\*1. Background and Rationale\*\* \*\*Clinical Need:\*\* * \*\*Carotid artery calcification\*\* is a major contributor to ischemic stroke, accounti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 \< 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.
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06936176
Start Date
May 12 2025
End Date
December 30 2027
Last Update
May 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing An Zhen Hospital of the Capital University of Medical Sciences
Beijing, China