Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07000045

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

Led by Annapoorna Kini · Updated on 2025-10-09

120

Participants Needed

1

Research Sites

116 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The NODULE-SHOCK trial is a prospective, investigator-initiated, single-center, randomized controlled trial designed to compare the efficacy of intravascular lithotripsy (IVL) with or without rotational atherectomy (RA) in patients with coronary calcified nodules (Cohort A), and operator-determined vs maximum IVL pulses in patients with non-nodular severe coronary calcium (Cohort B).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older who signed written informed consent
  • Clinical indication for coronary intervention
  • Undergoing PCI for a new calcified lesion with planned drug-eluting stent implantation
  • Native coronary artery with significant stenosis: 70% to less than 100% on angiography, or 50%-70% stenosis with evidence of ischemia (positive stress test, FFR ≤ 0.8, or OCT minimal lumen area ≤ 4.0 mm2)
  • Reference vessel diameter between 2.5 mm and 4.0 mm
  • Lesion length 5 mm or longer
  • Moderate to severe calcification of the target lesion confirmed by angiography
  • Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 at baseline
Not Eligible

You will not qualify if you...

  • 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 dual antiplatelet therapy (aspirin, clopidogrel, prasugrel, ticagrelor)
  • Planned surgery within 6 months unless dual antiplatelet therapy can be maintained
  • Life expectancy less than 12 months due to serious illness (e.g., advanced cancer, end-stage heart failure)
  • Severe kidney dysfunction (creatinine clearance below 30 mL/min) without dialysis
  • Concurrent participation in another investigational study
  • Referral for coronary artery bypass grafting after heart team discussion
  • Angiographic evidence of thrombus at the target lesion
  • Significant dissection at treatment site before intervention
  • Lesion with a stent placed within 10 mm
  • Last remaining vessel with severely compromised left ventricular function (LVEF below 30%)
  • Target lesion within a saphenous vein graft (SVG)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

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Research Team

K

Keisuke Yasumura, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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