Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment (NODULE-SHOCK)

Annapoorna Kini

Status: Enrolling

Conditions: Coronary Artery Disease; Coronary Calcification

Treatments: Device: Rotational atherectomy; Device: Intravascular lithotripsy

Study type: Interventional

Funder types: Other

Identifiers

NCT07000045

ISR20250319 (Other Grant/Funding Number)

STUDY-25-00266

Details and patient eligibility

About

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).

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 4 patient groups

RA + IVL (Cohort A)

Experimental group

Description:

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

Treatment:

Device: Intravascular lithotripsy

Device: Rotational atherectomy

IVL alone (Cohort A)

Active Comparator group

Description:

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

Treatment:

Device: Intravascular lithotripsy

Maximum IVL pulses (Cohort B)

Experimental group

Description:

Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using the maximum number of pulses per manufacturer's instructions.

Treatment:

Device: Intravascular lithotripsy

Operator-determined IVL pulses (Cohort B)

Active Comparator group

Description:

Patients with non-nodular severe coronary calcium treated with intravascular lithotripsy prior to stenting using a pulse number determined at the operator's discretion.

Treatment:

Device: Intravascular lithotripsy