|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P200039 / PAS001 |
Date Original Protocol Accepted |
06/04/2021
|
Date Current Protocol Accepted |
 
|
Study Name |
New Enrollment PAS Registry
|
Device Name |
Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
|
Clinical Trial Number(s) |
NCT03595176
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
External Registry
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
The study is a prospective, multicenter, observational, single-arm post-approval study using new data collected in the National Cardiovascular Data Registry (NCDR) CathPCI Registry. The objective of this study is to better understand the utilization, safety, and effectiveness of the Shockwave Coronary IVL System in a real-world setting.
|
Study Population |
Patients 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.
|
Sample Size |
Approximately 1000 patients in the CathPCI Registry including a minimum of 30 patients with permanent pacemakers [PPM] or implantable cardioverter defibrillators [ICDs].
|
Key Study Endpoints |
Safety endpoints: Mortality and procedure-related adverse events IVL-specific data reporting IVL-related ventricular arrhythmia IVL balloon loss of pressure and related serious dissections Safety of IVL in patients with PPM/ICD
|
Follow-up Visits and Length of Follow-up |
The timeline and milestones following approval of the protocol.
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
1212
|
Actual Number of Sites Enrolled |
1700
|
Patient Follow-up Rate |
n/a
|
Final Safety Findings |
1) Procedure related adverse event rate: 2.9% (35/1,212) 2) All cause death rate: 0.2% (3/1,212) 3) Sustained Ventricular Arrhythmia: 0.0% (0/153) 4) Balloon Loss of Pressure/Rupture: 1.3% (2/153) 5) Pacing issues with Cardiac Implantable Electronic Device: 0.0% (0/12)
|
Final Effect Findings |
n/a
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Study Strengths & Weaknesses |
strengths: real world data, large dataset weaknesses: limited long term data
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Recommendations for Labeling Changes |
yes
|