An interventional study of Intensive Preconditioning Group and Routine preconditioning strategy in Coronary Artery Calcification and Calcific Coronary Arteriosclerosis, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Active, not recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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:
A. 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.
B. 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.
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.
91 studies on the registry are indexed under Calcinosis; 19 are open to participants now.
This study's enrollment of 1,096 is above the median of 70 across 56 interventional studies indexed under Calcinosis.
Browse Calcinosis studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Intensive Preconditioning Group
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.
Device: Routine preconditioning strategy
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.
This includes compliant balloons, non-compliant balloons, cutting/scoring balloons, excimer laser, and rotational atherectomy, to be determined at the operator's discretion
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 \[TVR\])
Time frame: 1month; 12 months; 24 months
MACE
Including cardiovascular death, myocardial infarction, ischemia-driven revascularization, and stroke
Time frame: 1 month; 12 months; 24 months
Plan to share: Yes
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This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →