Calcification, Coronary Artery Disease
Conditions
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.
Interventions
DEVICEShockwave 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.
Sponsors
First Affiliated Hospital of Guangxi Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 30 days post index procedure | — |
| 30 days post index procedure | 9 months post index procedure | — |
Countries
China
Outcome results
None listed