* 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
1. \*\*Pre-treatment:\*\* Imaging (CT angiography, ultrasound) to confirm eligibility. 2. \*\*Procedure:\*\* Shockwave catheter breaks up calcium, followed by stent placement. 3. \*\*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: [email protected]
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).
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.
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.
Single group
Neurovascular Intravascular Shockwave Catheter
DeviceDevice: 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.
Procedural Success Rate
Successful stent deployment with residual stenosis \<30% after the procedure (via angiography).
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).
Device Success
Successful delivery, activation, and retrieval of the neurovascular intravascular shockwave (IVL) catheter without technical failure.
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.
Target Lesion Revascularization Rate
The incidence of revascularization treatment for the initially treated lesion vessel after surgery.
Ipsilateral Stroke Rate
The occurrence of a stroke event on the same side as the target vessel in the subject.
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