Coronary Artery Disease, Coronary Calcification
Conditions
Keywords
Coronary calcification, Calcified nodule, Intravascular lithotripsy, Rotational atherectomy, Optical coherence tomography, Percutaneous coronary intervention
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).
Interventions
Intravascular lithotripsy device used for calcium modification in coronary lesions, using either operator-determined or maximum pulsed numbers for lesion preparation prior to stenting.
DEVICERotational atherectomy
Rotational atherectomy device used to debulk calcified nodules before IVL and stent implantation.
Sponsors
Annapoorna Kini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are blinded to treatment allocation. Operators and investigators are unblinded.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minimum stent area (MSA) | Immediately after Index procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel failure (TVF) | during hospitalization, approximately 1-2 days, 30 days, and 12 months | Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization |
| Stent thrombosis | 12 months | 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. |
| Device success | Immediately after Index procedure | Successful lesion crossing and device delivery to the target site |
| Angiographic success | Immediately after Index procedure | 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) |
| Procedural success | Immediately after Index procedure | Procedural success defined as angiographic success and no in-hospital TVF |
| Number of Calcium fractures | Immediately after Index procedure | Number and presence of post-IVL calcium fractures identified on OCT |
| Pre- and post-dilatation ballon size | Immediately before and after Index procedure | Balloon size recorded during lesion preparation and post-dilatation |
| Pre- and post-dilatation inflation pressure | Immediately before and after Index procedure | Inflation pressure recorded during lesion preparation and post-dilatation |
| Total number of IVL pulses delivered to the lesion during treatment | Intraoperatively during Index procedure | IVL pulse characteristics - Total number of IVL pulses delivered to the lesion during treatment relative to overall lesion length and calcified segment length |
| Lesion length of IVL pulses delivered | Intraoperatively during Index procedure | IVL pulse characteristics - The lesion length over which pulses were applied, relative to overall lesion length and calcified segment length |
| Bailout or adjunctive calcium modification | Intraoperatively during Index procedure | Use of additional calcium modification device beyond initial randomized strategy |
Countries
United States
Contacts
Primary ContactKeisuke Yasumura, MD
Outcome results
None listed