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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160043 S001/ PAS001 |
| Date Original Protocol Accepted |
11/16/2017
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| Date Current Protocol Accepted |
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| Study Name |
Cont f/u of RESOLUTE ONYX 2.0 Clinical
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| Device Name |
Resolute Onyx Zotarolimus-Eluting Coronary Stent System
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| Clinical Trial Number(s) |
NCT02412501
NCT02419521
NCT03063749
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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: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Continued Follow-up of premarket cohort (RESOLUTE ONYX 2.0 Clinical Study)
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| Study Population |
Single arm study with Resolute Onyx Stent System
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| Sample Size |
101 subjects (already enrolled)
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| Key Study Endpoints |
Primary Endpoint is Target lesion failure (TLF) at 12 months, defined as Cardiac Death, Target Vessel Myocardial Infarction or Target Lesion Revascularization
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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 |
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-mon
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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.
NOTE: The safety and effectiveness key endpoints are similar
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| 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.
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