Shockwave vs. drill: which method best prepares calcified heart arteries for stents?
NCT ID NCT07750964
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial compares two procedures for treating severely calcified coronary arteries, a condition that makes stent placement difficult and risky. One method, rotational atherectomy, uses a tiny drill to grind away calcium, while the other, intravascular lithotripsy, uses sound waves to crack the calcium. The study will randomly assign about 190 patients to one of the two procedures and measure the resulting stent area to see if the newer sound-wave approach works as well as the established drilling method.
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 (IVL) and rotational atherectomy (RA) procedures
- What this could lead to
- If IVL proves as effective as RA, it could offer a safer, less damaging way to prepare calcified arteries for stents, potentially reducing complications.
- What could go wrong
- The trial is relatively small and early, and results may not apply to all patients. Both procedures carry risks, including vessel injury or microvascular dysfunction.
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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About 190 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2030
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: 1. Age ≥ 18 years; 2. Target lesion with diameter stenosis ≥ 50% (visual estimation) associated with evidence of myocardial ischemia; 3. Target lesion must be a de novo, in-situ severely calcified coronary lesion, where severe calcification is defined as: radiopacity visible prior to contrast injection and in the absence of cardiac pulsation, typically involving both sides of the vessel wall; and ≥270° circumferential calcification as evidenced by intravascular ultrasound (IVUS); 4. Target vessel reference diameter between 2.5 and 4.0 mm, with successful guidewire traversal; 5. A maximum of two non-target lesions requiring interventional treatment, which must be successfully treated prior to the target lesion; 6. Patients presenting with evidence of symptomatic or asymptomatic myocardial ischemia, stable or unstable angina pectoris, or prior myocardial infarction; 7. Signed written informed consent obtained. Exclusion Criteria: 1. Cardiogenic shock or hemodynamic instability; 2. Chronic total occlusion (CTO); 3. Requirement for intraprocedural mechanical circulatory support, such as intra-aortic balloon pump (IABP) or Impella device; 4. Acute ST-segment elevation myocardial infarction (STEMI) occurring within 1 month prior to enrollment; 5. Angiographically visible thrombus at the target lesion site; 6. Left main ostial lesion with stenosis ≥ 50%; 7. Left ventricular ejection fraction (LVEF) \< 40%; 8. New-onset stroke or transient ischemic attack (TIA) within 90 days; 9. Bypass graft lesion; 10. Coronary artery dissection of type B or greater (NHLBI classification); 11. Pregnant or lactating patients; 12. Life expectancy \< 1 year; 13. Active bleeding; 14. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m²; 15. Presence of cognitive or psychiatric disorders, as confirmed by clinical diagnosis or investigator assessment; 16. Illiteracy, semi-literacy, or any visual impairment, reading/writing disability that prevents the patient from independently reading the patient information sheet and personally providing written informed consent without assistance.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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