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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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Cont f/u of RESOLUTE ONYX 2.0 Clinical


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General
Study Status Progress Adequate
Application Number P160043 S001/ PAS001
Study Name Cont f/u of RESOLUTE ONYX 2.0 Clinical
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued Follow-up of premarket cohort (RESOLUTE ONYX 2.0 Clinical Study)
Study Population Description Single arm study with Resolute Onyx Stent System
Sample Size 101 subjects (already enrolled)
Data Collection Primary Endpoint is Target lesion failure (TLF) at 12 months, defined as Cardiac Death, Target Vessel Myocardial Infarction or Target Lesion Revascularization
Follow-up Visits and Length of Follow-up 3 years
Interim or Final Data Summary
Actual Number of Patients Enrolled RESOLUTE ONYX (2.25 mm TO 4.0 mm) Clinical Study: 75

RESOLUTE ONYX 2.0 mm Clinical Study: 101

Actual Number of Sites Enrolled RESOLUTE ONYX (2.25 mm TO 4.0 mm) Clinical Study: 15 US sites

RESOLUTE ONYX 2.0 mm Clinical Study : 21 US and 3 Japan

Patient Follow-up Rate RESOLUTE ONYX (2.25 mm TO 4.0 mm) Clinical Study: Subject follow-up compliance remained high through the 30 day, 6 month, 8 month, 12 month, 24 month, and 36 month follow-up visits. A total of 97.1% (67/69)

completed their 36-month visit within the protocol defined follow-up window.

RESOLUTE ONYX 2.0 mm Clinical Study: A total of 97.0% (98/101) of subjects

completed their 30-day visit within the protocol defined follow-up window, 99.0% (100/101) of

subjects compl
Final Safety Findings RESOLUTE ONYX (2.25 mm TO 4.0 mm) Clinical Study:

The TLF rate at 36 months is 14.7% (11/75), TVF is 18.7% (14/75), TVMI is 8.0% (6/75), MACE is 21.3% (16/75), and stent thrombosis is 1.3% (1/75). There were 6 deaths; 2 Cardiac and 4 Non-Cardiac Deaths at 36 months. Since the 24-month assessment, at 36 months, there were 3 more cases of TLF, TVF, TVMI, and Death, 5 more cases of MACE, and no cases of stent thrombosis.

RESOLUTE ONYX 2.0 mm Clinical Study:

The Resolute Onyx 2.0 mm event rates at 36 months post procedure are as follows: 13.9% (14/101) for TLF, 14.9% (15/101) for TVF, 4.0% (4/101) for TVMI, 14.9% (15/101) for MACE, and 0.0% (0/101) ARC definite/probable stent thrombosis. Rate of mortality is 3.0% (3/101), including cardiac mortality of 2.0% (2/101), and non cardiac mortality of 1.0% (1/101). There is no change in deaths, cardiac or non-cardiac from 24 months to 36 months.

NOTE: The safety and effectiveness key endpoints are similar

Final Effect Findings RESOLUTE ONYX (2.25 mm TO 4.0 mm) Clinical Study:

o The TLF rate at 36 months is 14.7% (11/75), TVF is 18.7% (14/75), TVMI is 8.0% (6/75), MACE is 21.3% (16/75), and stent thrombosis is 1.3% (1/75).

o There were 6 deaths; 2 Cardiac and 4 Non-Cardiac Deaths at 36 months.

o Since the 24-month assessment, at 36 months, there were 3 more cases of TLF, TVF, TVMI, and Death, 5 more cases of MACE, and no cases of stent thrombosis.

o ARC/SCAI defined major adverse events up to 1080 days. All MIs were adjudicated using two definitions; the Medtronic extended historical definition and the SCAI definition. Death and stent thrombosis were adjudicated using ARC definitions only. There were four (5.3%) non-cardiovascular deaths and two (2.7%) cardiac deaths, three (4.0%) SCAI defined MIs, and one (1.3%) ARC defined acute definite stent thrombosis.

o There were no UADEs reported through 36 months.



RESOLUTE ONYX 2.0 mm Clinical Study:

• The primary endpoint of TLF at 12 months was only 5.0%, meeting the pre-specified performance criterion (upper 1-sided 95% CI of 10.1%, compared with the performance goal of 19%, p < 0.001).

• The 12-month rate of key secondary clinical endpoints included 2.0% TLR, 3.0% TVMI, 5.0% TVF and 5.0% MACE rate.

• The ITT analysis on principal safety and effectiveness at discharge, as well as at 30 days, 180 days, 360 days, 720 days and 1080 days are summarized in Table 25.

• Follow-up data demonstrates that the 36-month rate of TLF was 13.9% (14/101), of TVF - 14.9% (15/101), of TVMI - 4.0% (4/101), and of MACE - 14.9% (15/101).

• There were no cases of stent thrombosis 0.0% (0/101) at 36 months, and there was a total of 3 deaths,



including 2 Cardiac Deaths and 1 Non-Cardiac Death.

• Between 24 and 36 months, there was one additional event of TLF, TVF, and MACE, while the rates of TVMI, stent thrombosis, and death did not change.



Cont f/u of RESOLUTE ONYX 2.0 Clinical Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 04/28/2018 04/26/2018 On Time
final report 04/28/2019 04/24/2019 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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