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Shockwave therapy may crack tough heart artery plaque

NCT ID NCT07340294

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

1,096 people

The number who actually took part.

Started

Oct 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital of Nanchang University (FAHNU)

    Nanchang, Jiangxi, China

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning, China

  • Tianjin Fourth Central Hospital

    Tianjin, China

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Other studies related to the condition(s) this trial covers.