Shockwave (intravascular lithotripsy) versus rotablation plus shockwave for treating calcified coronary nodules
Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs. Intravascular Lithotripsy Alone: A Prospective, Randomized Trial (NODULE-SHOCK)
This study will see if adding rotational atherectomy to intravascular lithotripsy leads to better stent expansion for people having PCI for calcified nodules, and will also test whether using maximum versus operator-selected IVL pulses is better for other severe coronary calcium.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07000045 on ClinicalTrials.gov |
What this trial studies
NODULE-SHOCK is a prospective, single-center, randomized trial enrolling two cohorts of patients undergoing PCI for heavily calcified coronary lesions. Cohort A randomizes patients with calcified nodules to rotational atherectomy followed by intravascular lithotripsy (IVL) or IVL alone prior to drug-eluting stent placement, while Cohort B randomizes patients with non-nodular severe calcium to operator-determined versus maximum IVL pulses. The primary endpoints are post-procedural minimum stent area measured by optical coherence tomography at the calcified nodule site (Cohort A) or at the site of maximum calcification (Cohort B). Procedures use standard PCI care with OCT imaging to quantify stent expansion and compare the two calcium modification strategies.
Who should consider this trial
Good fit: Adults (≥18) who consent and are undergoing PCI for a de novo, moderately to severely calcified native coronary lesion planned for DES with reference vessel diameter 2.5–4.0 mm, lesion length ≥5 mm, TIMI 3 flow, and angiographic stenosis meeting the trial criteria are ideal candidates.
Not a fit: Patients in cardiogenic shock, undergoing primary PCI for STEMI, with contraindications to dual antiplatelet therapy, pregnant or breastfeeding, or with non-calcified lesions or unsuitable vessel size are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the approaches could produce larger stent areas at heavily calcified sites, which may reduce the risk of stent under-expansion and future reintervention.
How similar studies have performed: Rotational atherectomy is an established technique and intravascular lithotripsy has shown promising results for calcified lesions, but randomized data directly comparing combined RA+IVL versus IVL alone—especially focused on calcified nodules—are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
New York, New York
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Annapoorna S Kini, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Keisuke Yasumura, MD
- Email: keisuke.yasumura@mountsinai.org
- Phone: (212) 241-4181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.