CRUSTAL Study in China

Active, not recruiting

• Conditions: Coronary Artery Disease; Calcification

• Registration Number: NCT05828186
• Lead Sponsor: First Affiliated Hospital of Guangxi Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-01
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-25
• Study Start: 2023-05-04
• Primary Completion: 2024-08-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedure success	in 48 hours post-procedure or prior to discharge, whichever comes first	Procedure success defined as successful stent implantation, residual stenosis degree \<30% (core laboratory), and no major adverse cardiac events (MACE) occurring during hospitalization
Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure	30 days post 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.

Secondary Outcome Measures

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

Trial Locations

Locations (6)

liuzhou People's Hospital; 🇨🇳 Liuzhou, Guangxi, China

Yulin First People's Hospital; 🇨🇳 Yulin, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanjing, Guanxi, China

Guilin People's Hospital; 🇨🇳 Guilin, China

Guiping People's Hospital; 🇨🇳 Guiping, China

Liuzhou labors' Hospital; 🇨🇳 Liuzhou, China