Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment

Purpose

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).

Conditions

  • Coronary Artery Disease
  • Coronary Calcification

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Cohort A: RA + IVL vs IVL alone for calcified nodules Cohort B: Operator-determined IVL pulses vs Maximum IVL pulses for non-CN severe calcium
Primary Purpose
Treatment
Masking
Single (Participant)
Masking Description
Participants are blinded to treatment allocation. Operators and investigators are unblinded.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
RA + IVL (Cohort A) 		Patients with coronary calcified nodules treated with rotational atherectomy followed by intravascular lithotripsy for lesion preparation prior to stenting.
  • 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.
Active Comparator
IVL alone (Cohort A) 		Patients with coronary calcified nodules treated with intravascular lithotripsy alone for lesion preparation prior to stenting.
  • 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.
Experimental
Maximum IVL pulses (Cohort B) 		Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using the maximum number of pulses per manufacturer's instructions.
  • 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.
Active Comparator
Operator-determined IVL pulses (Cohort B) 		Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using a pulse number determined at the operator's discretion.
  • 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.

Recruiting Locations

Mount Sinai Hospital
New York, New York 10029
Contact:
Annapoorna S Kini, MD
(212) 241-4181
annapoorna.kini@mountsinai.org

More Details

Status
Recruiting
Sponsor
Annapoorna Kini

Study Contact

Keisuke Yasumura, MD
(212) 241-4181
keisuke.yasumura@mountsinai.org

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).