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OpenTrials
Active, Not Recruiting

NCT Number: NCT05828186

CRUSTAL Study in China

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Calcification Calcinosis Calcium Metabolism Disorders Cardiovascular Diseases Coronary Disease Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

liuzhou People's Hospital, Liuzhou, Guangxi, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shockwave Coronary Intravascular Lithotripsy (IVL) catheter

Device

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

Primary outcomes

  1. Procedure success

    Time frame: 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

  2. Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure

    Time frame: 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 outcomes

  1. Vascular complications in the proudure

    Time frame: Immediately post index procedure

    Vascular complications is defined as:

    Perforation or Severe dissection or Acute occlusion or Consistent No-reflow/ slow flow

  2. Incidence of target lesion revascularization

    Time frame: 30 days post index procedure

  3. Incidence of target lesion revascularization

    Time frame: 6 months post index procedure

  4. 30 days post index procedure

    Time frame: 9 months post index procedure

  5. Incidence of target lesion revascularization

    Time frame: 12 months post index procedure

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Guangxi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 25, 2023
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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