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Intravascular Lithotripsy for Coronary Calcified Nodule Treatment

This study, called NODULE-SHOCK, is looking at better ways to treat coronary artery disease, specifically when there's calcium buildup in the heart's arteries (coronary calcification). Researchers are comparing two methods: intravascular lithotripsy (IVL), which uses sound waves to break up calcium, and rotational atherectomy (RA), which uses a tiny drill to remove calcium. The study aims to see if using IVL alone, or IVL combined with RA, is more effective for patients with calcified nodules. They are also comparing different ways to use IVL for patients with severe calcium. The main goal is to measure the minimum stent area right after the procedure, which indicates how well the artery is opened. You may be eligible if you are 18 or older and need a procedure for a calcified coronary artery.

Study design
This is a randomized controlled trial at a single center, planning to enroll 120 participants. It compares different treatment strategies for calcium in heart arteries.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, minimum stent area, is measured immediately after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07000045

Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment

Recruiting
NAAges 18+InterventionalTreatment
Annapoorna Kini
~120 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Intravascular lithotripsyRotational atherectomy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Minimum stent area (MSA)
Measured over Immediately after Index procedure

Conditions

Coronary Artery Disease
Coronary Calcification

Explore related trials

Calcified noduleCoronary Artery CalcificationCoronary Artery Disease

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Annapoorna S Kini, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Keisuke Yasumura, MD
[email protected]
(212) 241-4181
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Minimum stent area (MSA)Immediately after Index procedure

    Post-procedural minimum stent area measured at the site of the calcified nodule (Cohort A) or the point of maximum calcification (Cohort B), as assessed by optical coherence tomography (OCT)