Disrupt CAD III Post-Approval Study (PAS)

Completed

Brief Summary: The study design is a prospective, multicenter, observational, single-arm post-approval study using data collected in the National Cardiovascular Data Registry (NCDR®) CathPCI Registry®.

Detailed Description: Subject Population: Patients ≥18 years of age with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) and with clinical characteristics similar to the Disrupt CAD III IDE study. Approximately 1000 patients in the CathPCI Registry® (including a minimum of 30 patients with permanent pacemakers \[PPM\] or implantable cardioverter defibrillators \[ICDs\]) will be enrolled. Subjects will be followed through discharge.

Recruitment & Eligibility

Inclusion Criteria

Subject is ≥18 years of age
Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
Left ventricular ejection fraction >25% within 6 months
The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
LAD, RCA or LCX (or of their branches) with:
- Stenosis of ≥70% and <100% or
- Stenosis ≥50% and <99% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
The lesion length must not exceed 40 mm
The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation)
Evidence of calcification at the lesion site by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location

Exclusion Criteria

Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure
New York Heart Association (NYHA) class III or IV heart failure
Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
Subjects in cardiogenic shock or with clinical evidence of acute heart failure
Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
Previous stent within target lesion (in-stent restenosis)

Arm && Interventions

Group	Intervention	Description
Disrupt CAD III PAS Cohort	Shockwave C2 Coronary IVL	Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.

Primary Outcome Measures

Name	Time	Method
Number of Participants With IVL-related Ventricular Arrhythmia	Up to hospital discharge, approximately 24-48 hours
All-cause Death Rate	Up to hospital discharge, approximately 24-48 hours
Number of Participants With Procedure-related Adverse Events	Up to hospital discharge, approximately 24-48 hours
Number of Participants With IVL Balloon Loss of Pressure/Rupture	Up to hospital discharge, approximately 24-48 hours
Number of IVL-related Pacing Issues in Patients With PPM/ICD	Up to hospital discharge, approximately 24-48 hours	Events that may indicate an adverse device interaction including inappropriate inhibition of pacing during IVL device utilization, inappropriate ICD shock during IVL device utilization (for ICD patients only), and the need for device re-programming associated with IVL use (during or post procedure).
Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture	Up to hospital discharge, approximately 24-48 hours