Status:
RECRUITING
Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
Lead Sponsor:
Annapoorna Kini
Conditions:
Coronary Artery Disease
Coronary Calcification
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 rotation...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
October 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07000045
Start Date
October 6 2025
End Date
December 31 2027
Last Update
October 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mount Sinai Hospital
New York, New York, United States, 10029