NCT07000045Active, not recruiting
Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs. Intravascular Lithotripsy Alone: A Prospective, Randomized Trial (NODULE-SHOCK)
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 23 May 2025
- Start date
- Oct 2025
- Primary completion date
- Aug 2026
- Lead sponsor
- Annapoorna Kini
- Diseases
- Coronary artery disease
- NCT number
- NCT07000045
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From Oct 2025 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned surgery within 6 months unless DAPT can be maintained
- Concurrent participation in another investigational study
- Angiographic evidence of significant dissection at the treatment site prior to intervention
- Lesion with a previously placed stent within 10mm (visual estimate)
Other illness
- Primary PCI for ST-segment elevation myocardial infarction (STEMI)
- Known allergy or contraindication to DAPT (aspirin, clopidogrel, prasugrel, ticagrelor)
- Life expectancy \<12 months due to a serious medical illness (e.g., advanced cancer, end-stage heart failure)
- Referral for coronary artery bypass grafting (CABG) after a heart team discussion
Lab values
- Last remaining vessel with severely compromised left ventricular function (LVEF \<30%)
Other
- Cardiogenic shock at the time of procedure
- Pregnant, nursing, or childbearing potential without adequate contraception
- Severe kidney dysfunction (CrCl \<30 mL/min) without dialysis
- Angiographic evidence of thrombus at the target lesion
- Target lesion within a saphenous vein graft (SVG)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.