CRUSTAL Study in China

Sponsor

First Affiliated Hospital of Guangxi Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05828186

Collaborator

(none)

200

Enrollment

Location

32.1

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Calcification	Device: Shockwave Coronary Intravascular Lithotripsy (IVL) catheter

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 30, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Guangxi Medical University	Nanjing	Guanxi	China

Sponsors and Collaborators

First Affiliated Hospital of Guangxi Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital of Guangxi Medical University

ClinicalTrials.gov Identifier:

NCT05828186

Other Study ID Numbers:

IC-ISR001

First Posted:

Apr 25, 2023

Last Update Posted:

Apr 25, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Calcinosis

Study Results

No Results Posted as of Apr 25, 2023