CRUSTAL Study in China

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05828186
• Other study ID #: IC-ISR001
• Status: Recruiting
• Start date: May 4, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: First Affiliated Hospital of Guangxi Medical University
• Contact: Lang Li, Doctor
• Phone: 0771-5352512
• Email: drlilang[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calcification
• Calcinosis
• Coronary Artery Disease

Intervention

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.

Locations

Country	Name	City	State
China	Guiping People's Hospital	Guigang
China	Guilin People's Hospital	Guilin
China	Liuzhou labors' Hospital	Liuzhou
China	The First Affiliated Hospital of Guangxi Medical University	Nanjing	Guanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Incidence of target lesion revascularization		30 days post index procedure
Secondary	Incidence of target lesion revascularization		6 months post index procedure
Secondary	30 days post index procedure		9 months post index procedure
Secondary	Incidence of target lesion revascularization		12 months post index procedure