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

NCT ID: NCT07000045

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-06
• Study Completion Date: 2027-12-31

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).

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).

Conditions

Coronary Artery Disease; Coronary Calcification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RA + IVL (Cohort A)

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

Group Type: EXPERIMENTAL

Intravascular lithotripsy

Intervention Type: 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.

Rotational atherectomy

Intervention Type: DEVICE

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

IVL alone (Cohort A)

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

Group Type: ACTIVE_COMPARATOR

Intravascular lithotripsy

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Intravascular lithotripsy

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Intravascular lithotripsy

Intervention Type: 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.

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.

Intervention Type: DEVICE

Rotational atherectomy

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Annapoorna Kini

OTHER

Sponsor Role: lead

Responsible Party

Annapoorna Kini

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Annapoorna S Kini, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Hospital

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Keisuke Yasumura, MD

Role: CONTACT

keisuke.yasumura@mountsinai.org

(212) 241-4181

Facility Contacts

Annapoorna S Kini, MD

Role: primary

annapoorna.kini@mountsinai.org

(212) 241-4181

Keisuke Yasumura, MD

Role: backup

keisuke.yasumura@mountsinai.org

212-241-4181

Other Identifiers

ISR20250319

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY-25-00266

Identifier Type: -

Identifier Source: org_study_id