An interventional study of Super High-Pressure Non-Compliant Balloon and Intravascular Lithotripsy System in Vascular Calcification, sponsored by Lin Zhao. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Lin Zhao · Not applicable, Interventional, and Treatment
Study Design Prospective, multicenter, single-blind, randomized controlled trial
Hypothesis In patients with severely calcified coronary lesions undergoing rotational atherectomy (Rota), post-rotational lesion optimization using intravascular lithotripsy (IVL) is non-inferior to super high-pressure balloon (SHPB) in terms of final minimal lumen diameter (MLD), with potential differences in acute lumen gain, stent expansion, and periprocedural complications.
Inclusion Criteria
Exclusion Criteria
Randomization
After initial rotational atherectomy (burr ≤1.5 mm), eligible patients meeting imaging-defined "need for further lesion optimization" criteria will be randomized 1:1 to:
Rota + IVL group: Intravascular lithotripsy using pulsed ultrasonic energy (up to 80 pulses, 8 cycles) followed by stent implantation Rota + SHPB group: Super high-pressure balloon (≥30 atm) expansion followed by stent implantation Stratification by: Study center, Reference vessel diameter (2.5-3.0 mm vs. >3.0-4.0 mm)
Primary Endpoint Post-procedural minimal lumen diameter (MLD) measured by OCT/IVUS immediately after stent implantation and post-dilation Secondary Endpoints Procedural efficacy: Acute lumen gain, final stent expansion rate, minimal stent area, stent apposition Procedural safety: Periprocedural complications including coronary perforation, dissection, no-reflow/slow flow, acute stent thrombosis Clinical outcomes: MACE (composite of cardiac death, myocardial infarction, target vessel revascularization) at 30 days, 6 months, and 12 months Other outcomes: Major bleeding (BARC ≥2), acute kidney injury (KDIGO criteria), procedure duration, contrast volume, radiation exposure Sample Size Total: 162 patients (81 per group)
In-hospital monitoring until discharge Clinical follow-up at 30 days, 6 months, and 12 months Imaging follow-up (OCT/IVUS) selectively at designated centers as per protocol or clinical indication
Study Centers
Three tertiary hospitals with extensive experience in complex coronary interventions and calcified lesion management:
Study Duration January 2026 to December 2028 (3 years)
Severely calcified coronary lesions reduce vessel compliance, limit balloon expansion, and impair optimal stent deployment, leading to higher procedural risk. Rotational atherectomy (Rota) can modify superficial calcium but may be insufficient for deep or circumferential calcium. Intravascular lithotripsy (IVL) and super high-pressure balloon angioplasty (SHPB) are both used for additional calcium modification, but direct comparative evidence in the "post-Rota lesion optimization" setting is limited.
This multicenter, prospective, randomized, single-blind trial compares Rota + IVL versus Rota + SHPB for imaging-defined lesion optimization and periprocedural safety in severely calcified de novo coronary lesions, with clinical follow-up through 12 months.
Study design and sites
Core workflow (screening to final imaging)
Screening and baseline assessment
Initial rotational atherectomy (all participants)
Post-Rota "randomization trigger" assessment
Randomized lesion optimization and stent implantation Rota + IVL arm
Rota + SHPB arm
Immediate post-procedure imaging assessment (endpoint measurements)
Safety monitoring and quality control
Follow-up
Statistical considerations (overview)
82 studies on the registry are indexed under Vascular Calcification; 17 are open to participants now.
This study's planned enrollment of 162 is above the median of 64 across 56 interventional studies indexed under Vascular Calcification.
Browse Vascular Calcification studies →Lin Zhao is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Patients with severely calcified coronary lesions undergo rotational atherectomy followed by super high-pressure balloon angioplasty (SHPB) for calcium modification, then drug-eluting stent implantation with intravascular imaging guidance
Device: Super High-Pressure Non-Compliant Balloon
Patients with severely calcified coronary lesions undergo rotational atherectomy followed by intravascular lithotripsy (IVL) for calcium modification, then drug-eluting stent implantation with intravascular imaging guidance
Device: Intravascular Lithotripsy System
The super high-pressure balloon is a non-compliant balloon catheter capable of withstanding inflation pressures up to 35-40 atmospheres. The balloon is sized 1:1 to the reference vessel diameter and positioned across the calcified lesion. Inflation follows a stepwise pressure escalation protocol: 12 atm → 20 atm → 25 atm → 30 atm → 35 atm, with each pressure level maintained for 10-20 seconds. The high-pressure inflation creates controlled fractures in calcified plaque to facilitate subsequent stent deployment and expansion. The device is specifically designed for modification of severely calcified coronary lesions.
Also known as: SHPB, Ultra-High Pressure Balloon, Non-Compliant Balloon (rated to 35-40 atm), OPN NC Balloon
The intravascular lithotripsy (IVL) system is a balloon-based catheter device that delivers sonic pressure waves to fracture calcium in coronary arteries. The IVL balloon is sized 1:1 to the reference vessel diameter and positioned across the calcified lesion. Once inflated to 4 atm, the system delivers up to 80 pulses of localized pulsatile mechanical energy (50 Hz) to create circumferential and longitudinal calcium fractures in both superficial and deep calcium layers. Each treatment cycle consists of 10 pulses over 10 seconds. The device is specifically designed to modify severe coronary calcification to facilitate stent delivery and expansion.
Also known as: IVL, Coronary Intravascular Lithotripsy, Sonic Pressure Wave Lithotripsy, Shockwave Coronary IVL System
Minimum Lumen Diameter (MLD) assessed by intravascular imaging
The primary efficacy endpoint is the post-procedural minimum lumen diameter (MLD) measured by intravascular imaging (OCT or IVUS) immediately after stent implantation and final post-dilatation. MLD is defined as the smallest luminal diameter within the treated segment. An increase of ≥0.5mm compared to baseline MLD is considered clinically meaningful improvement. The measurement will be performed by the core imaging laboratory using standardized acquisition and analysis protocols with blinded adjudication.
Time frame: Immediately post-procedure (within 24 hours after PCI completion)
Acute lumen gain assessed by intravascular imaging
Acute lumen gain is defined as the difference between post-procedural MLD and baseline MLD, measured by OCT or IVUS.
Time frame: Immediately post-procedure (within 24 hours after PCI completion)
Final stent expansion rate assessed by intravascular imaging
Stent expansion rate is calculated as the ratio of minimum stent area to the reference vessel area, expressed as a percentage. Assessment includes minimum stent area, stent apposition, and coverage evaluated by OCT/IVUS.
Time frame: Immediately post-procedure (within 24 hours after PCI completion)
Major Adverse Cardiovascular Events (MACE) at 30 days
Composite endpoint of cardiac death, myocardial infarction, and target vessel revascularization at 30 days post-procedure.
Time frame: 30 days post-procedure
Major Adverse Cardiovascular Events (MACE) at 6 months
Composite endpoint of cardiac death, myocardial infarction, and target vessel revascularization at 6 months post-procedure.
Time frame: 6 months post-procedure
Major Adverse Cardiovascular Events (MACE) at 12 months
Composite endpoint of cardiac death, myocardial infarction, and target vessel revascularization at 12 months post-procedure.
Time frame: 12 months post-procedure
Incidence of periprocedural mechanical complications
Including coronary perforation (Ellis classification), coronary dissection, acute vessel closure, no-reflow or slow-flow (TIMI flow grade), periprocedural myocardial infarction (Fourth Universal Definition), and acute stent thrombosis (ARC definition).
Time frame: During procedure and hospital stay (up to 7 days post-procedure)
Bleeding events according to BARC criteria
Bleeding events classified according to the Bleeding Academic Research Consortium (BARC) definition, focusing on BARC type 2 or higher bleeding.
Time frame: 30 days post-procedure
Incidence of acute kidney injury
Acute kidney injury defined by KDIGO criteria: serum creatinine increase ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline.
Time frame: 48-72 hours post-procedure
Plan to share: Yes — Only IPD used in the results publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Lin Zhao