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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160043 / PAS001 |
| Study Name |
Cont f/u RESOLUTE ONYX Clinical
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| Device Name |
RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
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| Clinical Trial Number(s) |
NCT02412501 NCT02419521
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Continued Follow-up of premarket cohort (Core 2.25mm-4.00mm Clinical Study)
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| Study Population |
Single arm study with Resolute Onyx Stent System
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| Sample Size |
75 subjects (already enrolled)
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| Key Study Endpoints |
The primary safety and effectiveness endpoints is late lumen loss at 8 month post-index procedure. Unpowered secondary endpoints include acute success (device, lesion and procedure), cardiac death, target vessel MI, target lesion revascularization, MACE, target lesion failure, target vessel failure and stent thrombosis.
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| Follow-up Visits and Length of Follow-up |
3 years
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| 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
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| Actual Number of Sites Enrolled |
Actual number of study 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
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| 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 completed their 6-month visit within the protocol defined follow-up window, 99.0%
(100/101) completed their 12-month visit within the protocol defined follow-up window, 96.9%
(95/98) completed their 24-month visit within the protocol defined follow-up window, and 100.0%
(98/98) completed their 36-month visit within the protocol defined follow-up window.
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| 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.
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| Final Effect 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.
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.
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.
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