Clinical trial NCT07000045: Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment
Official title: Coronary Calcified Nodule Management With Rotational Atherectomy Plus Shockwave Intravascular Lithotripsy vs. Intravascular Lithotripsy Alone: A Prospective, Randomized Trial (NODULE-SHOCK)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Calcification
Keywords: Coronary calcification
Calcified nodule
Intravascular lithotripsy
Rotational atherectomy
Optical coherence tomography
Percutaneous coronary intervention
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Minimum stent area (MSA)
timeFrame: Immediately after Index procedure
Secondary outcomes:
measure: Number of Calcium fractures
timeFrame: Immediately after Index procedure
measure: Target vessel failure (TVF)
timeFrame: during hospitalization, approximately 1-2 days, 30 days, and 12 months
measure: Stent thrombosis
timeFrame: 12 months
measure: Device success
timeFrame: Immediately after Index procedure
measure: Angiographic success
timeFrame: Immediately after Index procedure
measure: Procedural success
timeFrame: Immediately after Index procedure
measure: Bailout or adjunctive calcium modification
timeFrame: Intraoperatively during Index procedure
measure: Pre- and post-dilatation ballon size
timeFrame: Immediately before and after Index procedure
measure: Pre- and post-dilatation inflation pressure
timeFrame: Immediately before and after Index procedure
measure: Total number of IVL pulses delivered to the lesion during treatment
timeFrame: Intraoperatively during Index procedure
measure: Lesion length of IVL pulses delivered
timeFrame: Intraoperatively during Index procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Annapoorna S Kini, MD
role: PRINCIPAL_INVESTIGATOR
References: