CRUSTAL Study in China

Study Overview
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Brief Summary
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This is a prospective, multicenter, single-arm registry study, aimed to evaluate the clinical outcomes of using Shockwave IVL catheter in the treatment of coronary artery calcification in real-world clinical practice.

Official Title
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Calcification Remodeling Utilizing Shockwave liThotripsy in Coronary Artery CaLcification (Guangxi Real-World Study)

Conditions
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Coronary Artery Disease, Calcification

Intervention / Treatment
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* Device: Shockwave Coronary Intravascular Lithotripsy (IVL) catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years. Patients with coronary artery calcification who are planned to undergo PCI and are deemed in need of Shockwave IVL catheter treatment by their physicians. The subject or their legal representative agrees to sign the informed consent form. Exclusion Criteria: The physician evaluates that the subject's expected lifespan is <1 year. The subject did not receive IVL treatment in the index procedure. The subject is pregnant or lactating. The subject is currently participating in another clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Shockwave Coronary Intravascular Lithotripsy (IVL) catheter|Patients with coronary artery calcification who are planned to undergo PCI and are deemed in need of Shockwave IVL catheter treatment by their physicians.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure success | Procedure success defined as successful stent implantation, residual stenosis degree <30% (core laboratory), and no major adverse cardiac events (MACE) occurring during hospitalization | in 48 hours post-procedure or prior to discharge, whichever comes first | 
| Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure | MACE is defined as: Cardiac death; or Myocardial Infarction (MI): Follow the Fourth Universal Definition of Myocardial Infarction ; or Target Vessel Revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure; or Target lesion thrombosis. | 30 days post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular complications in the proudure | Vascular complications is defined as: Perforation or Severe dissection or Acute occlusion or Consistent No-reflow/ slow flow | Immediately post index procedure | 
| Incidence of target lesion revascularization |  | 30 days post index procedure | 
| Incidence of target lesion revascularization |  | 6 months post index procedure | 
| 30 days post index procedure |  | 9 months post index procedure | 
| Incidence of target lesion revascularization |  | 12 months post index procedure |