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Shockwaves vs. Drill-and-Shockwaves: which clears heart blockages better?

NCT ID NCT07000045

Disease control Sponsor: Annapoorna Kini Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study compares two techniques for treating severely hardened heart arteries: using a special drill (rotational atherectomy) plus shockwave therapy versus shockwave therapy alone. About 120 adults with coronary artery disease will be randomly assigned to one of the two approaches. The goal is to see which method allows for better stent placement and long-term heart health.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2027

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 * Age ≥18 years who signed written informed consent * Presence of a clinical indication for coronary intervention * Patients undergoing PCI for a de novo calcified lesion with planned drug-eluting stent (DES) implantation * Native coronary artery with significant stenosis defined as: * ≥70% and \<100% stenosis on angiography, or * 50-70% stenosis with evidence of ischemia (positive stress test, FFR ≤ 0.8, or OCT minimal lumen area (MLA) ≤ 4.0 mm2) * Reference vessel diameter: ≥2.5 mm to ≤ 4.0 mm * Lesion length: ≥5mm * Moderate to severe calcification of the target lesion confirmed by angiography * Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 at baseline Exclusion Criteria * Cardiogenic shock at the time of procedure * Primary PCI for ST-segment elevation myocardial infarction (STEMI) * Pregnant, nursing, or childbearing potential without adequate contraception * Known allergy or contraindication to DAPT (aspirin, clopidogrel, prasugrel, ticagrelor) * Planned surgery within 6 months unless DAPT can be maintained * Life expectancy \<12 months due to a serious medical illness (e.g., advanced cancer, end-stage heart failure) * Severe kidney dysfunction (CrCl \<30 mL/min) without dialysis * Concurrent participation in another investigational study * Referral for coronary artery bypass grafting (CABG) after a heart team discussion * Angiographic evidence of thrombus at the target lesion * Angiographic evidence of significant dissection at the treatment site prior to intervention * Lesion with a previously placed stent within 10mm (visual estimate) * Last remaining vessel with severely compromised left ventricular function (LVEF \<30%) * Target lesion within a saphenous vein graft (SVG)

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease Coronary calcification

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

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