NCT07000045

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

Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs. Intravascular Lithotripsy Alone: A Prospective, Randomized Trial (NODULE-SHOCK)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Annapoorna Kini · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-06
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-05-31
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study