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New treatment option for Coronary Artery Disease
Official title Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
ClinicalTrials.gov ID: NCT07000045
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.