Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)

Launched by SHANGHAI BLUESAIL BOYUAN MEDICAL TECHNOLOGY CO., LTD. · Apr 13, 2025

Keywords

ClinConnect Summary

The CREATE Trial is a clinical study designed to evaluate a new treatment for patients with significant blockages in their carotid arteries caused by calcium buildup. This treatment involves a special device that uses sound waves to break up the calcium deposits, making it easier to place a stent, which is a small tube that helps keep the artery open and restores blood flow. To participate, individuals must be adults aged 18 to 80 who have severe narrowing in their carotid arteries and have not had success with standard balloon treatments.

If you or a loved one is eligible and chooses to participate, you will first undergo imaging tests to confirm the condition. The procedure itself is minimally invasive and involves using the shockwave device followed by stent placement. After the procedure, there will be follow-up assessments to monitor your recovery. Participation in this study is voluntary, and there are safety measures in place, including close monitoring for any potential risks. Overall, this trial aims to improve treatment outcomes for patients with calcified carotid lesions.

Gender

ALL

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.