Coronary Artery DiseaseNCT05828186
CRUSTAL Study in China
An observational study of Coronary Artery Disease and Calcification, run by First Affiliated Hospital of Guangxi Medical University at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Calcification
- What is being tested?
- Shockwave Coronary Intravascular Lithotripsy (IVL) catheter
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 6 sitesChina
- Study dates
- 4 May 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Guilin People's Hospital
Guilin
Guiping People's Hospital
Guiping
liuzhou People's Hospital
Liuzhou, Guangxi
Liuzhou labors' Hospital
Liuzhou
The First Affiliated Hospital of Guangxi Medical University
Nanjing, Guanxi
Yulin First People's Hospital
Yulin, Guangxi
About this study
Official title: Calcification Remodeling Utilizing Shockwave LiThotripsy in Coronary Artery CaLcification (Guangxi Real-World Study)
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
- Being tested
- Shockwave Coronary Intravascular Lithotripsy (IVL) catheter
- Medical subject headings
- Coronary Artery Disease, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 30 days post index procedure
Secondary outcomes (5)
Vascular complications in the proudure
Vascular complications is defined as:
Perforation or Severe dissection or Acute occlusion or Consistent No-reflow/ slow flow
Measured: Immediately post index procedure
Incidence of target lesion revascularization
Measured: 30 days post index procedure
Incidence of target lesion revascularization
Measured: 6 months post index procedure
30 days post index procedure
Measured: 9 months post index procedure
Incidence of target lesion revascularization
Measured: 12 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start4 May 2023
- Primary completion9 Aug 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828186
- Sponsor's protocol ID
- IC-ISR001
- Status last verified
- Dec 2024
- First submitted
- 1 Apr 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcification Remodeling Utilizing Shockwave LiThotripsy in Coronary Artery CaLcification (Guangxi Real-World Study)
- ClinicalTrials.gov ID
- NCT05828186
- Acronym / sponsor ID
- IC-ISR001
- Conditions
- Coronary Artery Disease, Calcification
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave Coronary Intravascular Lithotripsy (IVL) catheterPatients with coronary artery calcification who are planned to undergo PCI and are deemed in need of Shockwave IVL catheter treatment by their physicians. | Device | – |
Primary outcome
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
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.
5 secondary outcomes
Vascular complications in the proudure
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Calcification, run by First Affiliated Hospital of Guangxi Medical University at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success (time frame: in 48 hours post-procedure or prior to discharge, whichever comes first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.