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)
Facility
City
Region
Status
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
More First Affiliated Hospital of Guangxi Medical University trials in China
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.
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