Using shockwave therapy to treat calcified carotid artery blockages

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)）

This study is testing a new device that uses shockwaves to break up hard blockages in the carotid artery to see if it helps adults aged 18-80 who haven't had success with regular treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Bluesail Boyuan Medical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT06936176 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and efficacy of a new intravascular lithotripsy (IVL) device designed to treat calcified blockages in the carotid artery. The device uses sonic pressure waves to break up calcium deposits, which facilitates stent placement and restores blood flow. It targets adults aged 18-80 with severe carotid artery narrowing who have not responded to standard balloon dilation. The study aims to assess the surgical success rate and the occurrence of major adverse events within 30 days post-procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with severe carotid artery narrowing due to calcification who have failed standard balloon dilation.

Not a fit: Patients with recent strokes or heart attacks, uncontrolled hypertension, or other high-risk conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with calcified carotid artery stenosis, reducing the risk of stroke and other complications.

How similar studies have performed: Previous studies using similar intravascular lithotripsy techniques in coronary applications have shown high success rates and minimal complications, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80 years (inclusive), gender unrestricted.
2. 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.)
3. Intraoperative digital subtraction angiography (DSA) confirms carotid stenosis ≥50% (by NASCET criteria) or asymptomatic carotid stenosis ≥70% (by NASCET criteria).
4. Participants with a pre-enrollment modified Rankin Scale (mRS) score ≤2.
5. Participants planned for carotid artery stenting (CAS) who have failed conventional balloon dilation.
6. Patients or their legal guardians understand the purpose of the trial, provide informed consent, and agree to follow-up.

Exclusion Criteria:

1. Target lesion caused by non-atherosclerotic disease.
2. Participants with complete occlusion of the target lesion or contralateral carotid artery.
3. Participants with severe disability due to cerebral infarction.
4. Participants with large acute or subacute thrombi near the target lesion, or with arteriovenous malformations or aneurysms.
5. Participants with tortuous target lesion vessels that prevent stent placement.
6. Participants with symptomatic severe stenosis in other cerebral vessels.
7. Participants requiring concurrent or additional surgical interventions during the trial period.
8. Participants with tandem severe stenosis or occlusion in vessels proximal or distal to the target lesion.
9. Participants who have had a myocardial infarction or large cerebral infarction within 2 weeks prior to screening.
10. Participants who have had intracranial hemorrhage within 3 months prior to screening.
11. 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.
12. Participants with uncontrolled hypertension (systolic blood pressure persistently ≥180 mmHg or diastolic blood pressure persistently ≥110 mmHg).
13. 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.
14. Participants with coagulopathy (INR ≥2.0) or contraindications to heparin or antiplatelet agents.
15. Participants with active infections.
16. Participants unable to use cerebral protection devices.
17. Participants allergic to components of the investigational device or contrast agents (excluding rash).
18. Participants with life expectancy less than 1 year.
19. Pregnant or breastfeeding women.
20. Participants currently enrolled in another drug or medical device clinical trial (before reaching the primary endpoint).
21. Other situations where the investigator deems the participant unsuitable for the trial.

Where this trial is running

Beijing

• Beijing An Zhen Hospital of the Capital University of Medical Sciences — Beijing, China (Recruiting)

Conditions Carotid Artery Stenosis