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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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 device used to debulk calcified nodules before IVL and stent implantation.
Mount Sinai Hospital
New York, New York, United States
RECRUITINGMinimum 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)
Time frame: Immediately after Index procedure
Number of Calcium fractures
Number and presence of post-IVL calcium fractures identified on OCT
Time frame: Immediately after Index procedure
Target vessel failure (TVF)
Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization
Time frame: during hospitalization, approximately 1-2 days, 30 days, and 12 months
Stent thrombosis
Definite or probable stent thrombosis according to academic research consortium-2 (ARC-2) definitions. Definite stent thrombosis is defined as the presence of a thrombus within the stent, within 5 mm of the stent edge, or in a side branch of the stented segment, confirmed by angiography or pathology, along with evidence of acute ischemia such as symptoms, ECG changes, or elevated cardiac biomarkers. Probable is defined as a myocardial infarction in the territory of the stented vessel without angiographic confirmation and without another obvious cause.
Time frame: 12 months
Device success
Successful lesion crossing and device delivery to the target site
Time frame: Immediately after Index procedure
Angiographic success
Angiographic success defined as stent deployment with residual stenosis \<30% and TIMI 3 flow without significant angiographic complications (perforation, major dissection, distal embolization, slow flow, or no flow)
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Time frame: Immediately after Index procedure
Procedural success
Procedural success defined as angiographic success and no in-hospital TVF
Time frame: Immediately after Index procedure
Bailout or adjunctive calcium modification
Use of additional calcium modification device beyond initial randomized strategy
Time frame: Intraoperatively during Index procedure
Pre- and post-dilatation ballon size
Balloon size recorded during lesion preparation and post-dilatation
Time frame: Immediately before and after Index procedure
Pre- and post-dilatation inflation pressure
Inflation pressure recorded during lesion preparation and post-dilatation
Time frame: Immediately before and after Index procedure
Total number of IVL pulses delivered to the lesion during treatment
IVL pulse characteristics - Total number of IVL pulses delivered to the lesion during treatment relative to overall lesion length and calcified segment length
Time frame: Intraoperatively during Index procedure
Lesion length of IVL pulses delivered
IVL pulse characteristics - The lesion length over which pulses were applied, relative to overall lesion length and calcified segment length
Time frame: Intraoperatively during Index procedure