Recruiting

IVL & RA

Sponsor:

Annapoorna Kini

Code:

NCT07000045

Conditions

Coronary Artery Disease

Coronary Calcification

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intravascular lithotripsy

Rotational atherectomy

Study Details

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 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

Study ID

NCT07000045

Start date

Oct 6, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RA + IVL (Cohort A)

Patients with coronary calcified nodules treated with rotational atherectomy followed by intravascular lithotripsy for lesion preparation prior to stenting.

active comparator: IVL alone (Cohort A)

Patients with coronary calcified nodules treated with intravascular lithotripsy alone 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.

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.

Interventions

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.

Rotational atherectomy

Rotational atherectomy device used to debulk calcified nodules before IVL and stent implantation.

Primary outcome measure

  • Minimum stent area (MSA) [ Time Frame: Immediately after Index procedure ]

Central Contacts and Locations

Central contacts

Keisuke Yasumura, MD

(212) 241-4181keisuke.yasumura@mountsinai.org

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Annapoorna S Kini, MD

(212) 241-4181annapoorna.kini@mountsinai.org

Keisuke Yasumura, MD

212-241-4181keisuke.yasumura@mountsinai.org

Principal Investigator:

Annapoorna S Kini

More Information

Sponsor

Annapoorna Kini

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Coronary calcification
  • Calcified nodule
  • Intravascular lithotripsy
  • Rotational atherectomy
  • Optical coherence tomography
  • Percutaneous coronary intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Annapoorna Kini on 2026-07-13.