Shockwave therapy may crack tough heart artery plaque
NCT ID NCT07340294
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether using a shockwave device (intravascular lithotripsy) along with standard artery preparation can improve outcomes for people with moderate to severe coronary artery calcification. About 1,096 participants will be split into two groups: one gets standard prep alone, the other gets standard prep plus the shockwave. Researchers will track heart-related events over 24 months to see if the combo approach reduces the need for repeat procedures or prevents heart attacks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Intravascular lithotripsy (shockwave device)
- What this could lead to
- If successful, this could offer a better way to treat hardened arteries in the heart, reducing the risk of heart attacks or repeat procedures.
- What could go wrong
- This is an early-stage study with no phase designation, so results are uncertain. The device may not improve outcomes over standard care, and there are risks like vessel injury or complications from the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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1,096 people
The number who actually took part.
- Started
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Oct 2025
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
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The First Affiliated Hospital of Nanchang University (FAHNU)
Nanchang, Jiangxi, China
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The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
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Tianjin Fourth Central Hospital
Tianjin, China
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Other studies related to the condition(s) this trial covers.
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