CRUSTAL Study in China

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Calcification
• Intervention / Treatment: Device: Shockwave Coronary Intravascular Lithotripsy (IVL) catheter

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• China
  • Guilin, China
    • Guilin People'S Hospital
  • Guiping, China
    • Guiping People's Hospital
  • Liuzhou, China
    • Liuzhou labors' Hospital
  • Guangxi
    • Liuzhou, Guangxi, China
      • Liuzhou People's Hospital
    • Yulin, Guangxi, China
      • Yulin First People's Hospital
  • Guanxi
    • Nanjing, Guanxi, China
      • The First Affiliated Hospital of Guangxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with coronary artery calcification who are planned to undergo percutaneous coronary intervention (PCI) and are deemed suitable to receive Shockwave IVL catheter treatment by their physicians.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Actual): August 9, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 1, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Calcium Metabolism Disorders; Coronary Artery Disease; Calcinosis
• Other Study ID Numbers: IC-ISR001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No