N/A
N=1,212
Disrupt CAD III Post-Approval Study (PAS)
Coronary Artery Disease · Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT05021757 ↗Enrolled (actual)
1,212
Serious AEs
2.9%
Results posted
Feb 2024
Primary outcome: Primary: All-cause Death Rate — 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Shockwave C2 Coronary IVL (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shockwave Medical, Inc.
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Death Rate |
3 | — |
| PRIMARY Number of Participants With Procedure-related Adverse Events |
35 | — |
| PRIMARY Number of Participants With IVL-related Ventricular Arrhythmia |
— | — |
| PRIMARY Number of Participants With IVL Balloon Loss of Pressure/Rupture |
2 | — |
| PRIMARY Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture |
— | — |
| PRIMARY Number of IVL-related Pacing Issues in Patients With PPM/ICD |
— | — |
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®.
Eligibility Criteria
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 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)
Data sourced from ClinicalTrials.gov (NCT05021757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.