Using shockwave therapy to treat calcified carotid artery blockages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.