CRUSTAL Study in China

NCT05828186 | Active Not Recruiting

• 1 other identifier: IC-ISR001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Coronary Artery Disease; Calcification

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  30 days post index procedure

Secondary Outcomes (5)

• Vascular complications in the proudure

  Immediately post index procedure

• Incidence of target lesion revascularization

  30 days post index procedure

• Incidence of target lesion revascularization

  6 months post index procedure

• 30 days post index procedure

  9 months post index procedure

• Incidence of target lesion revascularization

  12 months post index procedure

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with coronary artery calcification who are planned to undergo percutaneous coronary intervention (PCI) and are deemed suitable to receive Shockwave IVL catheter treatment by their physicians.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University: lead

Study Sites (6)

liuzhou People's Hospital

Liuchow, Guangxi, China

Location

Yulin First People's Hospital

Yulin, Guangxi, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanjing, Guanxi, China

Location

Guilin People's Hospital

Guilin, China

Location

Guiping People's Hospital

Guiping, China

Location

Liuzhou labors' Hospital

Liuchow, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Calcinosis

Interventions

Catheters

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: April 25, 2023
• Study Start: May 4, 2023
• Primary Completion: August 9, 2024
• Study Completion: December 31, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CN (6)