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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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PROMUS Element Plus US PAS


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General
Study Status Progress Adequate
Application Number P110010 S001/ PAS001
Date Current Protocol Accepted 08/24/2012
Study Name PROMUS Element Plus US PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, open-label, multi-center registry study
Study Population Description PLATINUM-like patients, including at least 200 patients treated with PROMUS Element Plus long lesion stents 32/38 mm lengths (2.50-4.0mm diameters).
Sample Size 2,689 consecutive, consented patients from up to 65 sites in order to attain 906 PLATINUM like patients from the US PAS (33.7% of the enrolled patients)
Data Collection Primary: Cardiac death or myocardial infarction rate through 12 months post stent implantation among all PLATINUM-like patients

Secondary: Stent thrombosis rate, longitudinal stent deformation, and PROMUS Element plus related MACE, cardiac death/MI, TVF, TVR, cardiac death, and MI.

Follow-up Visits and Length of Follow-up 5 years

30- days, 180-days, and annually through 5 years post intervention

Interim or Final Data Summary
Actual Number of Patients Enrolled Three hundred and forty-three (343) subjects were enrolled including platinum-like patients (n=13) and non-platinum like patients (n=328)

Two patients with unknown reference vessel diameter were not included in either group but included in the overall Long Lesion population.
Actual Number of Sites Enrolled Fifty-three (53) sites
Patient Follow-up Rate 84% (246/293) at 5 years
Final Safety Findings Final safety and effectiveness findings (key endpoints) through 5 years:

All Subjects

Stent thrombosis (ST) rate, using ARC definition (definite/probable) in the overall patient population was 3.6% (11/304). Stent thrombosis (ARC definition, definite/probable) related to PROMUS Element plus rate was 2.6% (8/304).

The overall rate of longitudinal stent deformation was 0.15% (1/670).

The overall major adverse cardiac event (MACE, composite of cardiac death, myocardial infarction or MI, and target vessel revascularization or TVR) rate was 29.6% (90/304). PROMUS Element Plus-related MACE rate was 24.7% (75/304).

The overall cardiac death or MI rate was 12.8% (39/304). PROMUS Element Plus-related cardiac death or MI rate was 10.5% (32/304).

The overall target vessel failure (TVF) rate was 28.6% (87/304). PROMUS Element Plus-related TVF rate was 24.7% (75/304).

TThe overall cardiac death rate was 9.2% (28/304). PROMUS Element Plus-related cardiac death rate was 8.9% (27/304).

The overall MI rate was 5.6% (17/304). PROMUS Element Plus-related MI rate was 3.3% (10/304).

All death rate was 16.4% (50/304). Non-cardiac death rate was 7.2% (22/304)

All death or MI rate was 20.1% (61/304).

Subgroup Outcomes: Platinum-like and Non-Platinum like Patient Populations

Stent thrombosis (ARC, Definite/Probable) rate in PLATINUM-like patients was 0.0% (0/12) and in non-PLATINUM-like patients was 3.8% (11/290).

MACE rate related to PROMUS element Plus in PLATINUM-like patients was 33.3% (4/12) and in non-PLATINUM-like patients was 24.5% (71/290).

Cardiac death or MI rate related to PROMUS element Plus in PLATINUM-like patients was 8.3% (1/12) and in non-PLATINUM-like patients was 10.7% (31/290).

TVR rate related to PROMUS element Plus in PLATINUM-like patients was 33.3% (4/12),he overall TVR rate was 21.7% (66/304). PROMUS Element Plus-related TVR rate was 17.8% (54/304).

and in non-PLATINUM-like patients was 17.2% (50/290).

TVF rate related to PROMUS element Plus in PLATINUM-like patients was 33.3% (4/12), and in non-PLATINUM-like patients was 24.5% (71/290).

Study Strengths & Weaknesses Strengths: The PROMUS Element Plus US post-approval Long Lesion study was a prospective, open-label, multi-center study that evaluated outcomes data of patients treated with at least one PROMUS Element Plus stent length 32 or 28 mm (excluding sizes 2.25 x 32 mm) in routine practice. Patients were consecutively enrolled, and the target enrollment of 200 patients was exceeded. The follow-up rate achieved through 5- years was 84%.

Weakness: Compared to non-platinum like patient population, the sample size of platinum-like patient population (n=13) was too small to make any meaningful comparison of the safety and effectiveness outcomes between the two subgroups.
Recommendations for Labeling Changes Labeling change is recommended to reflect the long-term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key

endpoint, follow-up visits etc.), final results, study strengths and limitations of the PAS.


PROMUS Element Plus US PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month report 08/31/2012 09/20/2012 Overdue/Received
6 month report 11/30/2012 11/16/2012 On Time
9 month report 06/01/2013 06/03/2013 Overdue/Received
18 month report 11/30/2013 11/20/2013 On Time
two year report 06/01/2014 05/30/2014 On Time
30 month report 11/21/2014 11/21/2014 On Time
three year report 11/21/2015 11/25/2015 Overdue/Received
unscheduled report 01/27/2016 01/27/2016 On Time
four year report 11/21/2016 11/22/2016 Overdue/Received
five year report 11/21/2017 11/15/2017 On Time
final report 11/21/2018 10/05/2018 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

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