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

Summary

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).

Eligibility

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)

Conditions3

Locations1 site

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