NCT07000045 · Annapoorna Kini
Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
(NODULE-SHOCK)
What this study is about
The NODULE-SHOCK trial is a forward-looking, investigator-initiated, single-center, randomly assigned controlled trial designed to compare the effectiveness of intravascular lithotripsy (IVL) with or without rotational atherectomy (RA) in patients with coronary calcified nodules (group of participants A), and operator-determined vs maximum IVL pulses in patients with non-nodular severe coronary calcium (group of participants B).
View original scientific description
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).
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
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations