Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravascular lithotripsy, Rotational atherectomy.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Coronary Calcification. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs. Intravascular Lithotripsy Alone: A Prospective, Randomized Trial (NODULE-SHOCK)
Overview
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).
Detailed description
The trial consists of two cohorts:
* Patients with calcified nodules (CN) (Cohort A) * Patients with non-nodular severe coronary calcium (Cohort B)
Randomization will occur as follows:
* Rotational atherectomy followed by intravascular lithotripsy (IVL) or IVL alone for lesion preparation prior to stenting (Cohort A). * Operator-determined or maximum IVL pulses prior to stenting. (Cohort B)
The trial is designed to compare two calcium modification strategies in each cohort with regard to the primary endpoints of post-procedural minimum stent area assessed by optical coherence tomography at the CN site (Cohort A) and at the site of maximum calcification (Cohort B).
Interventions
- Device Intravascular lithotripsy
Intravascular lithotripsy device used for calcium modification in coronary lesions, using either operator-determined or maximum pulsed numbers for lesion preparation prior to stenting. - Device Rotational atherectomy
Rotational atherectomy device used to debulk calcified nodules before IVL and stent implantation.
Primary outcome measures
- Minimum stent area (MSA) [Time frame: Immediately after Index procedure]
Secondary outcome measures (11)
- Number of Calcium fractures [Time frame: Immediately after Index procedure]
- Target vessel failure (TVF) [Time frame: during hospitalization, approximately 1-2 days, 30 days, and 12 months]
- Stent thrombosis [Time frame: 12 months]
- Device success [Time frame: Immediately after Index procedure]
- Angiographic success [Time frame: Immediately after Index procedure]
- Procedural success [Time frame: Immediately after Index procedure]
- Bailout or adjunctive calcium modification [Time frame: Intraoperatively during Index procedure]
- Pre- and post-dilatation ballon size [Time frame: Immediately before and after Index procedure]
- Pre- and post-dilatation inflation pressure [Time frame: Immediately before and after Index procedure]
- Total number of IVL pulses delivered to the lesion during treatment [Time frame: Intraoperatively during Index procedure]
- Lesion length of IVL pulses delivered [Time frame: Intraoperatively during Index procedure]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mount Sinai Hospital — New York
Identifiers
NCT: NCT07000045 · STUDY-25-00266 · ISR20250319