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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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New Enrollment PAS Registry


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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
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
Study Strengths & Weaknesses strengths: real world data, large dataset
weaknesses: limited long term data
Recommendations for Labeling Changes yes


New Enrollment PAS Registry Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/13/2021 08/11/2021 On Time
1 year report 02/12/2022 02/09/2022 On Time
18 month report 08/13/2022 08/04/2022 On Time
final report 02/12/2023 12/15/2022 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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