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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-New Enrollment Study


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General
Study Status Progress Adequate
Application Number P140003 / PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
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 Objective: to evaluate the safety and effectiveness of the IMPELLA

2.5 System compared to a predefined Performance Goal (PG) based

on the PROTECT II 90 days Major Adverse Events (MAE) rates.



Design: a multicenter, prospective single arm study. This is a new enrollment study.

Study Population Description High risk subjects indicated for nonemergent percutaneous treatment after heart team evaluation including a cardiac surgeon of at least one de novo or restenotic lesion in a native coronary vessel

or bypass graft.



The high risk subjects are defined by the combination of anatomical and left ventricular function criteria:

a) Ejection Fraction =< 35% AND

¿ Intervention on the last patent coronary conduit

at least one of the following criteria:

¿ Intervention on an unprotected left main coronary artery

Or,

b) Ejection Fraction =< 30% and intervention on patient presenting with triple vessel disease.

Three-vessel or triple vessel disease is defined as at least one significant stenosis* in all three major epicardial territories: Left Anterior Descending Artery (LAD) and/or side branch, left circumflex artery (LCX) and/or side branch, Right Coronary Artery (RCA) and or side branch.



*Significant stenosis is defined as at least 50% diameter stenosis by visual estimate or any total occlusion. In the case of left coronary artery dominance, a lesion in the LAD and the proximal LCX qualifies as three-vessel disease.



No comparator group.

Sample Size A total of up to 70 sites will be enrolled. At least 20 or more sites will be non-IDE sites and will enroll 25-35% of the patients. No study center (site) is allowed to have more than 20% of all subjects. Assuming the true proportion of 90 day MAE is 0.45, a total of 335 evaluable subjects will provide 90% power to reject the null hypothesis with one-side alpha error of 5%. Assuming 10% loss to follow-up to 90 days, 369 subjects will be enrolled in the study.
Data Collection Main Safety Endpoints:

A composite rate of the following 10 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 >=5 min requiring inotropic/pressor medications or IV fluid

9) Cardiopulmonary resuscitation or Ventricular arrhythmia

requiring cardioversion

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



Secondary Safety/Effectiveness Endpoints:

¿ Improved baseline hemodynamics post support initiation as

measured by maximal increase in Mean Arterial Pressure within

30 min of support initiation.

¿ Improvement in Left Ventricular Ejection Fraction (LVEF) at 90

days as compared to baseline

¿ Improvement in NYHA class at 90 days as compared to baseline



Additional Exploratory Endpoints:

1.Rate for each of the individual components of the composite

primary endpoint at 90 days;



2.Procedural safety endpoint: composite endpoint at 30 days post

index procedure including:

- Death

- Stroke or TIA

- Need for vascular operation

- Peri-procedural myocardial infarction

- Transfusion of 2 units of PRBCs

- Increase in aortic insufficiency by more than one grade

- Acute renal dysfunction



3. Procedure effectiveness endpoint: composite at 30 days post

index procedure, i.e. alive at 30 days with none of the following:

- Procedural hypotension requiring treatment

- Failure to achieve angiographic success

- Intra-procedural cardiopulmonary respiration or cardioversion.



3. Long term assessment (composite at 90 day and 1 year): Proportion of patients alive and none of the following: spontaneous myocardial infarction, repeat re-hospitalization for heart failure or repeat revascularization (PCI or CABG).



4. Composite endpoint at 90 days and 1 year post index procedure: Major Adverse Cardiac and Cerebrovascular Events (MACCE), including death, stroke, myocardial infarction, repeat revascularization

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

Pre- and during the PCI procedure, immediately following the PCI procedure or device explant, in the ICU or the floor where the patient will spend the remainder of his or her hospital stay, at hospital discharge, 30 days, 90 days, and 1 year post PCI.


OSB Lead-New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/21/2015 09/30/2015 Overdue/Received
one year report 03/22/2016 03/23/2016 Overdue/Received
18 month report 09/20/2016 09/22/2016 Overdue/Received
two year report 03/22/2017 03/23/2017 Overdue/Received
three year report 03/22/2018    
four year report 03/22/2019    
five year report 03/21/2020    


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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