CRUSTAL Study in China

First Affiliated Hospital of Guangxi Medical University

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Calcification

Treatments: Device: Shockwave Coronary Intravascular Lithotripsy (IVL) catheter

Study type: Observational

Funder types: Other

Identifiers

NCT05828186

IC-ISR001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.