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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-Impella PROTECTED PCI PAS cVAD Registry


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General
Study Status Study Pending
Application Number P140003 S008/ PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-Impella PROTECTED PCI PAS cVAD Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is a prospective, multicenter, single-arm post-approval study (PAS) of use of the percutaneous Impella devices in elective or urgent high-risk percutaneous coronary intervention (PCI).

The study objective is to monitor post market safety and efficacy trends of the Impella 2.5 and CP devices in high-risk PCI patient population by assessing outcomes at discharge and outcomes at 90 days relative to a performance goal of 53%.

Study Population Description The study population will consist of adult patients (age = 22 years old) supported with the Impella 2.5 or Impella CP for the approved indication of elective or urgent high-risk PCI, who are enrolled in the cVAD registry at U.S. institutions (both IDE and non-IDE sites) after the PMA post market study approval. Patients will be enrolled consecutively without interruption at all participating sites, without preselection.

Sample Size Approximately 750 subjects at the cVAD registry sites will be treated to compare a composite rate of ten (10) major adverse events (MAE) at 90 days to the performance goal of 53%. This number was chosen to ensure enrollment of at least 369 subjects who are similar to the original PMA Impella 2.5 cohort in PROTECT II. The number of PROTECT II like patients needed (369) was chosen to provide a 90% power to reject the null hypothesis in favor of the alternative hypothesis with the assumption (from the PROTECT II data):

The true proportion of MAE (pPAS) at 90 days is 45%*;

Margin of 8%;

The Performance Goal is 53%;

The power of the study is 90%; and

The one-sided alpha error is 5%.

*Determined with the FDA based on the PROTECT II study results.

Data Collection Primary Endpoints:

A composite rate of the following intra-procedural and post-procedural major adverse events* (MAE) at 90 days post index procedure:

1. Death;

2. Myocardial infarction;

3. Stroke/TIA;

4. Repeat revascularization;

5. Need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia;

6. Acute renal dysfunction;

7. Increase in aortic insufficiency by more than one grade;

8. Severe hypotension defined as systolic blood pressure <90 mmHg for greater than or equal to 5 minutes requiring inotropic/pressor medications or IV fluid;

9. Cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion; and

10. Failure to achieve angiographic success defined as residual stenosis < 30% after stent implantation.

*Complete definitions of the components of the primary endpoint along with other adverse events are provided in the Appendix A of the study protocol.



Secondary Endpoints:

1. Improved hemodynamics post support initiation as compared to baseline, as measured by maximum increase in mean arterial pressure within 30 min of support initiation.

2. Improvement in LVEF at 90 days as compared to baseline.

3. Improvement in NYHA class at 90 days as compared to baseline.

Follow-up Visits and Length of Follow-up 1 year


OSB Lead-Impella PROTECTED PCI PAS cVAD Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/01/2017 03/23/2017 On Time
one year report 12/01/2017    
18 month report 06/01/2018    
two year report 12/01/2018    
three year report 12/01/2019    
four year report 11/30/2020    
five year report 11/30/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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