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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 Progress Adequate
Application Number P200039 / PAS001
Date Current Protocol Accepted  
Study Name New Enrollment PAS Registry
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 Design Description 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 Description 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].
Data Collection 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 this protocol are as follows:

First subject enrolled within 6 months

20% of subjects enrolled within 12 months

50% of subjects enrolled within 18 months

100% of subjects enrolled within 24 months

Submission of Final study report: 3 months from study completion (i.e. last subject, last follow-up date)

Subjects will be followed through discharge. A minimum of 150 patients will be followed 30 days post-procedure.



New Enrollment PAS Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/13/2021 08/11/2021  
1 year report 02/12/2022    
18 month report 08/13/2022    
2 year report 02/12/2023    
3 year report 02/12/2024    


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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