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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P150003 S054/ PAS001 |
| Date Original Protocol Accepted |
03/19/2021
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| Date Current Protocol Accepted |
|
| Study Name |
Synergy Megatron PAS
|
| Device Name |
SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
|
| Comparison Group |
No 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 |
This is a post-market, standard of care, real-world observational study to assess the clinical outcomes of the SYNERGY XLV Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) less than or equal to 28 mm in length (by visual estimate) in native coronary arteries greater than or equal to 3.50 mm to less than or equal to 5.00 mm in diameter (by visual estimate).
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| Study Population |
A patient is an acceptable candidate for treatment with a SYNERGY XLV stent if treated in accordance with the applicable guidelines on PCI, the SYNERGY IFU, and the Declaration of Helsinki. Sites should follow their local standard of care and approach consecutive patients for inclusion in the trial.
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| Sample Size |
A minimum of 100 subjects will be enrolled at up to 20 US sites.
|
| Key Study Endpoints |
The primary endpoint is the rate of Target Lesion Failure (TLF) rate at 12-months.
Secondary endpoints include rates of TLR, TLF, TVR, TVF, MI (Q-Wave and non-Qwave), Death (All, Cardiac, Non-Cardiac), Cardiac Death or MI, All Death or MI, All Death or MI or TVR, Stent Thrombosis (ARC Definitions) at 6-months, 12-months, 2-years, and 3-years. In addition, secondary endpoints will technical and clinical success rates.
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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 |
100
|
| Actual Number of Sites Enrolled |
8
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| Patient Follow-up Rate |
100% of patients have >= 365 days follow-up, 89.8% have >= 730 days follow-up. 8/100 of subjects were lost to follow-up, and 1 subject declined to take part in 2-year follow-up.
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| Final Safety Findings |
There were a total of 12 deaths, with 6 being cardiac-related. 11 non-Q-wave MIs were reported that were related to the target vessel and 3 of these were peri-procedural. TLR occurred in 5 patients that were treated with PCI (3 patients) or CABG (2 patients). One patient experienced a definite ST on the day of the index procedure
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| Final Effect Findings |
The rate of TLF at 24 months was 17.7% (17/96) in the ITT population. The 95% upper confidence bound (one-sided) is 18.3%. The rates of technical and clinical procedural success were 96.0%.
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| Study Strengths & Weaknesses |
This was a single-arm post-approval study with a high technical and clinical procedural success rate (96.0%) supporting the safety and effectiveness of using the SYNERGY XLV (Megatron) coronary stent system to treat patients with atherosclerotic lesions <=28mm in length and between 3.5 and 5.0mm in diameter. The study enrolled patients with more health complications than typically present in similar studies (average patient age ~70 years, 82% had 3V CAD, 19.8% LM disease, and 21.4% presented with STEMI) which may have increased the number of non-procedure or device related deaths observed in the study.
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| Recommendations for Labeling Changes |
The Megatron IFU should be updated to include this trial, including the study purpose, study design, primary and secondary endpoints, patient population & demographics, lesion criteria, follow-up rate & duration, adverse events, 12-month and 2-year results, final safety findings, and final effectiveness findings
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