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Clinical Trials in China / NCT05828186
Active, not recruiting Observational

CRUSTAL Study in China

NCT05828186 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital of Guangxi Medical University
Phase
Observational
Started
2023-05-04
Last updated
2024-12-05

Condition(s) studied

Coronary Artery DiseaseCalcification

Investigational drug(s) / intervention(s)

Shockwave Coronary Intravascular Lithotripsy (IVL) catheter

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (6)

FacilityCityRegionStatus
liuzhou People's Hospital Liuzhou Guangxi
Yulin First People's Hospital Yulin Guangxi
The First Affiliated Hospital of Guangxi Medical University Nanjing Guanxi
Guilin People's Hospital Guilin China
Guiping People's Hospital Guiping China
Liuzhou labors' Hospital Liuzhou China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05828186 on ClinicalTrials.gov ↗ ← All trials in China