Health TrialsbyHealthPanel

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

ConditionsCoronary Artery DiseaseCoronary Calcification
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnnapoorna Kini

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

≥70% and <100% stenosis on angiography, or

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravascular lithotripsy

    Device

    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

    Rotational atherectomy device used to debulk calcified nodules before IVL and stent implantation.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: RA + IVL (Cohort A)Experimental treatment 2 interventions
Group B: IVL alone (Cohort A)Active comparator 1 intervention
Group C: Maximum IVL pulses (Cohort B)Experimental treatment 1 intervention
Group D: Operator-determined IVL pulses (Cohort B)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Minimum 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

Secondary outcomes

1

Number of Calcium fractures

Number and presence of post-IVL calcium fractures identified on OCT

Time frame
Immediately after Index procedure
2

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
3

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
4

Device success

Successful lesion crossing and device delivery to the target site

Time frame
Immediately after Index procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Annapoorna Kini

Lead sponsor

Icahn School of Medicine at Mount Sinai

Sponsor institution

Source ClinicalTrials.gov
Apply now