Coronary Artery CalcificationCALC-IVLNCT07340294
ClinicAL outComes of IntraVascular Lithotripsy Combined With Conventional Lesion Preparation in Patients With Moderate to Severe Coronary Artery Calcification
A study testing Intensive Preconditioning Group and Routine preconditioning strategy in people with Coronary Artery Calcification and Calcific Coronary Arteriosclerosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 sites in China.
Trial summary
The goal of this clinical trial is to investigate whether the clinical outcomes of combined application of intravascular lithotripsy (IVL) following routine preconditioning are superior to those of routine preconditioning alone in patients with moderate-to-severe coronary artery calcification (CAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Calcification, Calcific Coronary Arteriosclerosis
- What is being tested?
- Intensive Preconditioning Group and Routine preconditioning strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,096 participants
- Where
- 4 sitesChina
- Study dates
- 24 Oct 2025to 31 Jul 2029
- Phase
- Interventional
- 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
Who may be able to join
- Patients ≥ 18 years old
- Acute or chronic coronary syndrome requiring PCI
- De novo coronary lesions (excluding bypass grafts and prior stented lesions) with a target vessel reference diameter of ≥ 2.5 mm and ≤ 4.0 mm
- Moderate to severe calcification, meeting one of the following criteria: • Intravascular imaging criteria: IVUS calcium score ≥ 2 points (IVUS scoring standards: a. Calcification > 270 degrees and length > 5 mm; b. Circumferential calcification (360 degrees); c. Calcific nodules; d. Vessel diameter < 3.5 mm) OCT calcium score ≥ 3 points (OCT scoring standards: a. Calcification ≤ 180 degrees: 0 points; > 180 degrees: 2 points; b. Thickness ≤ 0.5 mm: 0 points; > 0.5 mm: 1 point; c. Length ≤ 5 mm: 0 points; > 5 mm: 1 point) • Contrast-based classification criteria apply when intravascular imaging devices cannot pass: Coronary angiography shows clear high-density calcific shadows visible during cardiac pulsation, or clear high-density calcific shadows visible both during and without cardiac pulsation, with the length of calcific shadows on both sides of the target lesion > 5 mm.
- Willing and able to provide written informed consent
Who cannot join
- Patients under 18 years of age
- Patients unable to provide informed consent
- Pregnant or lactating female patients (pregnancy test must be performed within 7 days before surgery for women of childbearing age)
- Thrombus detected by angiography or intravascular imaging
- Patients with an expected life expectancy of less than 1 year
- Hemodynamically unstable patients
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- Patients with known contraindications to heparin, anticoagulants, antiplatelet drugs, contrast agents, or other related medications
- Patients with active bleeding
- Patients with a new-onset stroke or transient ischemic attack (TIA) within 90 days before enrollment
- Patients scheduled to undergo other cardiac interventional procedures or cardiac surgery within 30 days after PCI
- Patients with ST-segment elevation myocardial infarction (STEMI) or cardiogenic shock occurring within 7 days
- Severe renal insufficiency (eGFR ≤ 30 ml/min)
- Left main coronary artery disease
- Presence of type C-F dissection in the target vessel
- Aneurysm within 10 mm of the target lesion
Trial locations and contacts
4 sites in 1 country.
China4 sites
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
The First Affiliated Hospital of Nanchang University (FAHNU)
Nanchang, Jiangxi
The People's Hospital of Liaoning Province
Shenyang, Liaoning
Tianjin Fourth Central Hospital
Tianjin
About this study
The goal of this clinical trial is to investigate whether the clinical outcomes of combined application of intravascular lithotripsy (IVL) following routine preconditioning are superior to those of routine preconditioning alone in patients with moderate-to-severe coronary artery calcification (CAC). Its core research questions are as follows:
- To evaluate whether routine or combined application of shockwave intravascular lithotripsy can effectively reduce the target vessel failure rate in moderate-to-severe coronary artery calcification lesions.
- To evaluate the long-term prognosis of patients with coronary artery calcification.
The researchers will compare the experimental group (routine preconditioning plus IVL) and the control group (routine preconditioning alone) to determine whether the combined use of intravascular lithotripsy following routine preconditioning can improve patient prognosis.
Read the detailed description
Revascularization of severe coronary artery calcification (CAC) lesions is associated with high technical difficulty and poor prognosis, and remains one of the major unmet challenges in the diagnosis and treatment of coronary heart disease (CHD) at present. As an important marker for the severity of atherosclerosis, CAC is closely correlated with the risk of recurrent cardiovascular events after revascularization and future cardiovascular events, with severe CAC lesions increasing the incidence of these events by 20%-40%. Despite existing research on the pathogenesis, progression, risk stratification and therapeutic strategies of CAC, there is a lack of standardized criteria for selecting medical or surgical treatment strategies and optimized revascularization protocols for CAC patients. Therefore, optimizing current revascularization strategies is of great significance.
The proportion of patients with coronary artery calcification (CAC) is on the rise among those undergoing percutaneous coronary intervention (PCI).Existing studies have found that the prevalence of CAC lesions ranges as high as 67% to 90% in the middle-aged and elderly populations. Research indicates that CAC significantly elevates the risk of intraoperative and postoperative complications of PCI, further increasing the likelihood of in-stent restenosis and repeat revascularization, which ultimately leads to a higher risk of mortality. Current preconditioning strategies prior to stent implantation for CAC include high-pressure balloon dilation, cutting balloon dilation, rotational atherectomy, and excimer laser ablation, among other approaches.However, most existing studies have focused on comparing the efficacy of different preconditioning methods-such as the superiority of ultra-high-pressure balloons versus cutting balloons, or rotational atherectomy versus cutting balloons-and have mainly emphasized stent implantation success rates and immediate stent expansion outcomes, while neglecting the long-term prognosis of patients. In particular, relevant research remains insufficient regarding combination therapy regimens that integrate multiple preconditioning methods. In recent years, numerous domestic and international studies have confirmed the efficacy of shockwave balloon technology in the treatment of coronary calcified lesions, which can significantly reduce the rate of stent implantation failure and improve stent expansion rate. Nevertheless, the strategy of intensive preconditioning combined with shockwave balloon therapy still requires verification through large-sample randomized controlled clinical trials.
With population aging and the rising incidence of diabetes mellitus and renal insufficiency, the proportion of patients with CAC lesions is expected to further increase. Therefore, it is particularly important to explore optimized strategies for improving the poor revascularization outcomes in CAC patients.
In summary, by optimizing revascularization strategies, this study aims to establish a more precise and efficient diagnosis and treatment pathway for CAC. Subsequent randomized controlled clinical trials will further clarify the value of these strategies, laying a foundation for promoting breakthroughs in the clinical diagnosis and treatment of cardiovascular diseases, which is of great significance for improving the national cardiovascular health level.
- Being tested
- Intensive Preconditioning Group, Routine preconditioning strategy
- Keywords
- atherosclerosi, calcification, coronary artery calcification
- Medical subject headings
- Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Preconditioning GroupDevice
Routine Preconditioning Strategy plus IVL (IVL may be performed before, during, or after the routine preconditioning strategy, with IVL being mandatory).The ratio of the IVL catheter size to the reference vessel diameter of the target lesion is 1:1. The IVL catheter is inflated to 4 atmospheres (atm) at the target lesion and delivers 10 pulses, followed by deflation to restore blood perfusion. A maximum of 80 pulses may be delivered, and the IVL catheter can be repositioned within the lesion. For diffuse lesions involving different reference diameters, IVL catheters of different sizes may be utilized.
Routine preconditioning strategyDevice
This includes compliant balloons, non-compliant balloons, cutting/scoring balloons, excimer laser, and rotational atherectomy, to be determined at the operator's discretion
| Study group | Role | What they receive |
|---|---|---|
| Intensive Preconditioning Group | Experimental | Routine preconditioning strategy + IVL Routine Preconditioning Strategy plus IVL (IVL may be performed before, during, or after the routine preconditioning strategy, with IVL being mandatory).The ratio of the IVL catheter size to the reference vessel diameter of the target lesion is 1:1. The IVL catheter is inflated to 4 atmospheres (atm) at the target lesion and delivers 10 pulses, followed by deflation to restore blood perfusion. A maximum of 80 pulses may be delivered, and the IVL catheter can be repositioned within the lesion. For diffuse lesions involving different reference diameters, IVL catheters of different sizes may be utilized. Receives: Device: Intensive Preconditioning Group |
| Control group | Other | Routine preconditioning strategy This includes compliant balloons, non-compliant balloons, cutting/scoring balloons, excimer laser, and rotational atherectomy, to be determined at the operator's discretion. Receives: Device: Routine preconditioning strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
target vessel failure rate
24-month target vessel failure (TVF) rate (a composite endpoint of cardiovascular death, target vessel myocardial infarction [TVMI], and clinically indicated target vessel revascularization [TVR])
Measured: 1month; 12 months; 24 months
Secondary outcomes (1)
MACE
Including cardiovascular death, myocardial infarction, ischemia-driven revascularization, and stroke
Measured: 1 month; 12 months; 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start24 Oct 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery CalcificationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,096 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, The First Affiliated Hospital of Nanchang University, The People's Hospital of Liaoning Province, Tianjin Forth Central Hospital
- Responsible party
- Sponsor
- Investigators
- Bingchen Liu, Phd,MD, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, ChinaBingchen Liu, Phd,MD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340294
- Sponsor's protocol ID
- 2025-0812
- Acronym
- CALC-IVL
- Status last verified
- Oct 2025
- First submitted
- 6 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ClinicAL outComes of IntraVascular Lithotripsy Combined With Conventional Lesion Preparation in Patients With Moderate to Severe Coronary Artery Calcification
- ClinicalTrials.gov ID
- NCT07340294
- Acronym / sponsor ID
- CALC-IVL / 2025-0812
- Keywords
- atherosclerosi, calcification, coronary artery calcification
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,096 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, The First Affiliated Hospital of Nanchang University, The People's Hospital of Liaoning Province, Tianjin Forth Central Hospital
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 14 Jan 2026 (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.
The goal of this clinical trial is to investigate whether the clinical outcomes of combined application of intravascular lithotripsy (IVL) following routine preconditioning are superior to those of routine preconditioning alone in patients with moderate-to-severe coronary artery calcification (CAC). Its core research questions are as follows:
- To evaluate whether routine or combined application of shockwave intravascular lithotripsy can effectively reduce the target vessel failure rate in moderate-to-severe coronary artery calcification lesions.
- To evaluate the long-term prognosis of patients with coronary artery calcification.
The researchers will compare the experimental group (routine preconditioning plus IVL) and the control group (routine preconditioning alone) to determine whether the combined use of intravascular lithotripsy following routine preconditioning can improve patient prognosis.
Detailed description
Revascularization of severe coronary artery calcification (CAC) lesions is associated with high technical difficulty and poor prognosis, and remains one of the major unmet challenges in the diagnosis and treatment of coronary heart disease (CHD) at present. As an important marker for the severity of atherosclerosis, CAC is closely correlated with the risk of recurrent cardiovascular events after revascularization and future cardiovascular events, with severe CAC lesions increasing the incidence of these events by 20%-40%. Despite existing research on the pathogenesis, progression, risk stratification and therapeutic strategies of CAC, there is a lack of standardized criteria for selecting medical or surgical treatment strategies and optimized revascularization protocols for CAC patients. Therefore, optimizing current revascularization strategies is of great significance.
The proportion of patients with coronary artery calcification (CAC) is on the rise among those undergoing percutaneous coronary intervention (PCI).Existing studies have found that the prevalence of CAC lesions ranges as high as 67% to 90% in the middle-aged and elderly populations. Research indicates that CAC significantly elevates the risk of intraoperative and postoperative complications of PCI, further increasing the likelihood of in-stent restenosis and repeat revascularization, which ultimately leads to a higher risk of mortality. Current preconditioning strategies prior to stent implantation for CAC include high-pressure balloon dilation, cutting balloon dilation, rotational atherectomy, and excimer laser ablation, among other approaches.However, most existing studies have focused on comparing the efficacy of different preconditioning methods-such as the superiority of ultra-high-pressure balloons versus cutting balloons, or rotational atherectomy versus cutting balloons-and have mainly emphasized stent implantation success rates and immediate stent expansion outcomes, while neglecting the long-term prognosis of patients. In particular, relevant research remains insufficient regarding combination therapy regimens that integrate multiple preconditioning methods. In recent years, numerous domestic and international studies have confirmed the efficacy of shockwave balloon technology in the treatment of coronary calcified lesions, which can significantly reduce the rate of stent implantation failure and improve stent expansion rate. Nevertheless, the strategy of intensive preconditioning combined with shockwave balloon therapy still requires verification through large-sample randomized controlled clinical trials.
With population aging and the rising incidence of diabetes mellitus and renal insufficiency, the proportion of patients with CAC lesions is expected to further increase. Therefore, it is particularly important to explore optimized strategies for improving the poor revascularization outcomes in CAC patients.
In summary, by optimizing revascularization strategies, this study aims to establish a more precise and efficient diagnosis and treatment pathway for CAC. Subsequent randomized controlled clinical trials will further clarify the value of these strategies, laying a foundation for promoting breakthroughs in the clinical diagnosis and treatment of cardiovascular diseases, which is of great significance for improving the national cardiovascular health level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Preconditioning Group | Experimental | Device: Intensive Preconditioning GroupRoutine preconditioning strategy + IVL Routine Preconditioning Strategy plus IVL (IVL may be performed before, during, or after the routine preconditioning strategy, with IVL being mandatory).The ratio of the IVL catheter size to the reference vessel diameter of the target lesion is 1:1. The IVL catheter is inflated to 4 atmospheres (atm) at the target lesion and delivers 10 pulses, followed by deflation to restore blood perfusion. A maximum of 80 pulses may be delivered, and the IVL catheter can be repositioned within the lesion. For diffuse lesions involving different reference diameters, IVL catheters of different sizes may be utilized. |
| Control group | Other | Device: Routine preconditioning strategyRoutine preconditioning strategy This includes compliant balloons, non-compliant balloons, cutting/scoring balloons, excimer laser, and rotational atherectomy, to be determined at the operator's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 years old
- Acute or chronic coronary syndrome requiring PCI
- De novo coronary lesions (excluding bypass grafts and prior stented lesions) with a target vessel reference diameter of ≥ 2.5 mm and ≤ 4.0 mm
- Moderate to severe calcification, meeting one of the following criteria: • Intravascular imaging criteria: IVUS calcium score ≥ 2 points (IVUS scoring standards: a. Calcification > 270 degrees and length > 5 mm; b. Circumferential calcification (360 degrees); c. Calcific nodules; d. Vessel diameter < 3.5 mm) OCT calcium score ≥ 3 points (OCT scoring standards: a. Calcification ≤ 180 degrees: 0 points; > 180 degrees: 2 points; b. Thickness ≤ 0.5 mm: 0 points; > 0.5 mm: 1 point; c. Length ≤ 5 mm: 0 points; > 5 mm: 1 point) • Contrast-based classification criteria apply when intravascular imaging devices cannot pass: Coronary angiography shows clear high-density calcific shadows visible during cardiac pulsation, or clear high-density calcific shadows visible both during and without cardiac pulsation, with the length of calcific shadows on both sides of the target lesion > 5 mm.
- Willing and able to provide written informed consent
Key exclusion criteria (15 listed)
- Patients under 18 years of age
- Patients unable to provide informed consent
- Pregnant or lactating female patients (pregnancy test must be performed within 7 days before surgery for women of childbearing age)
- Thrombus detected by angiography or intravascular imaging
- Patients with an expected life expectancy of less than 1 year
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 |
|---|---|---|
| Intensive Preconditioning GroupRoutine Preconditioning Strategy plus IVL (IVL may be performed before, during, or after the routine preconditioning strategy, with IVL being mandatory).The ratio of the IVL catheter size to the reference vessel diameter of the target lesion is 1:1. The IVL catheter is inflated to 4 atmospheres (atm) at the target lesion and delivers 10 pulses, followed by deflation to restore blood perfusion. A maximum of 80 pulses may be delivered, and the IVL catheter can be repositioned within the lesion. For diffuse lesions involving different reference diameters, IVL catheters of different sizes may be utilized. | Device | Intensive Preconditioning Group |
| Routine preconditioning strategyThis includes compliant balloons, non-compliant balloons, cutting/scoring balloons, excimer laser, and rotational atherectomy, to be determined at the operator's discretion | Device | Control group |
Primary outcome
target vessel failure rate
Time frame: 1month; 12 months; 24 months
24-month target vessel failure (TVF) rate (a composite endpoint of cardiovascular death, target vessel myocardial infarction [TVMI], and clinically indicated target vessel revascularization [TVR])
1 secondary outcome
MACE
Time frame: 1 month; 12 months; 24 months
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 14 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
Bingchen Liu, Phd,MD study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Bingchen Liu, Phd,MD principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Preconditioning Group and Routine preconditioning strategy in people with Coronary Artery Calcification and Calcific Coronary Arteriosclerosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 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 5 inclusion and 15 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 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
target vessel failure rate (time frame: 1month; 12 months; 24 months). 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 14 Jan 2026.