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

NCT07000045 | Recruiting DMC FDA Device

• 2 other identifiers: STUDY-25-00266ISR20250319
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Minimum stent area (MSA)

  Post-procedural minimum stent area measured at the site of the calcified nodule (Cohort A) or the point of maximum calcification (Cohort B), as assessed by optical coherence tomography (OCT)

  Immediately after Index procedure

Secondary Outcomes (11)

• Number of Calcium fractures

  Immediately after Index procedure

• Target vessel failure (TVF)

  during hospitalization, approximately 1-2 days, 30 days, and 12 months

• Stent thrombosis

  12 months

• Device success

  Immediately after Index procedure

• Angiographic success

  Immediately after Index procedure

Study Arms (4)

RA + IVL (Cohort A)

EXPERIMENTAL

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

Device: Intravascular lithotripsy; Device: Rotational atherectomy

IVL alone (Cohort A)

ACTIVE COMPARATOR

Patients with coronary calcified nodules treated with intravascular lithotripsy alone for lesion preparation prior to stenting.

Device: Intravascular lithotripsy

Maximum IVL pulses (Cohort B)

EXPERIMENTAL

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

Operator-determined IVL pulses (Cohort B)

ACTIVE COMPARATOR

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

Interventions

Intravascular lithotripsy DEVICE

Intravascular lithotripsy device used for calcium modification in coronary lesions, using either operator-determined or maximum pulsed numbers for lesion preparation prior to stenting.

IVL alone (Cohort A); Maximum IVL pulses (Cohort B); Operator-determined IVL pulses (Cohort B); RA + IVL (Cohort A)

Rotational atherectomy DEVICE

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

RA + IVL (Cohort A)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• % 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

You may not qualify 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)
• 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)

Sponsors & Collaborators

• Annapoorna Kini: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atherectomy, Coronary

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Atherectomy; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• Annapoorna S Kini, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keisuke Yasumura, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to treatment allocation. Operators and investigators are unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: May 31, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)