Disrupt CAD III Post-Approval Study (PAS)

New Enrollment Post Approval Registry for the Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05021757

Enrollment

1212

Registered

2021-08-25

Start date

2021-03-10

Completion date

2022-03-31

Last updated

2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Infarction

Keywords

Intravascular Lithotripsy, Percutaneous Coronary Intervention

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.

Interventions

DEVICEShockwave C2 Coronary IVL

PCI procedure using a Shockwave C2 coronary IVL catheter

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Subject is ≥18 years of age 2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI 3. Left ventricular ejection fraction \>25% within 6 months 4. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure 5. 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 6. The lesion length must not exceed 40 mm 7. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation) 8. 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

1. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure 2. New York Heart Association (NYHA) class III or IV heart failure 3. Renal failure with serum creatinine \>2.5 mg/dL or chronic dialysis 4. Subjects in cardiogenic shock or with clinical evidence of acute heart failure 5. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft 6. Previous stent within target lesion (in-stent restenosis)

Design outcomes

Primary

Measure	Time frame	Description
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-related Ventricular Arrhythmia	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 Participants With Serious Coronary Dissection Following 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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Disrupt CAD III PAS Cohort 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. Shockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter	1,212
Total	1,212

Baseline characteristics

Characteristic	Disrupt CAD III PAS Cohort
Age, Continuous	73.4 years STANDARD_DEVIATION 9
Race (NIH/OMB) American Indian or Alaska Native	2 Participants
Race (NIH/OMB) Asian	36 Participants
Race (NIH/OMB) Black or African American	68 Participants
Race (NIH/OMB) More than one race	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants
Race (NIH/OMB) Unknown or Not Reported	42 Participants
Race (NIH/OMB) White	1060 Participants
Region of Enrollment United States	1212 participants
Sex: Female, Male Female	330 Participants
Sex: Female, Male Male	882 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	3 / 1,212
other Total, other adverse events	0 / 1,212
serious Total, serious adverse events	35 / 1,212