CRUSTAL Study in China

N/AActive Not RecruitingNCT05828186

First Affiliated Hospital of Guangxi Medical University200 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Coronary Artery Disease Calcification

Interventions

Shockwave Coronary Intravascular Lithotripsy (IVL) catheterDEVICE

Patients with coronary artery calcification who are planned to undergo PCI and are deemed in need of Shockwave IVL catheter treatment by their physicians.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

liuzhou People's Hospital

Liuchow, 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

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 30 days post index procedure

Secondary Outcomes

Vascular complications in the proudure

Vascular complications is defined as: Perforation or Severe dissection or Acute occlusion or Consistent No-reflow/ slow flow

Time frame: Immediately post index procedure

Incidence of target lesion revascularization

Time frame: 30 days post index procedure

Incidence of target lesion revascularization

Time frame: 6 months post index procedure

30 days post index procedure

Time frame: 9 months post index procedure

Incidence of target lesion revascularization

Time frame: 12 months post index procedure

Data from ClinicalTrials.gov

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