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Trial Outcomes & Findings for SYNERGY China: Assess SYNERGY Stent in China (NCT NCT02499692)

NCT ID: NCT02499692

Last Updated: 2020-09-16

Results Overview

Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

1 day

Results posted on

2020-09-16

Participant Flow

Participant milestones

Participant milestones
Measure
SYNERGYTM Coronary Stent System
Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Overall Study
STARTED
103
Overall Study
COMPLETED
103
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SYNERGY China: Assess SYNERGY Stent in China

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SYNERGYTM Coronary Stent System
n=103 Participants
Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Age, Continuous
58.92 years
STANDARD_DEVIATION 8.74 • n=5 Participants
Sex: Female, Male
Female
31 Participants
n=5 Participants
Sex: Female, Male
Male
72 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician

Outcome measures

Outcome measures
Measure
SYNERGYTM Coronary Stent System
n=103 Participants
Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Technical Success Rate
98.1 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure
SYNERGYTM Coronary Stent System
n=103 Participants
Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Target Lesion Revascularization (TLR) Rate
0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure
SYNERGYTM Coronary Stent System
n=103 Participants
Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Target Lesion Failure (TLF) Rate
0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure
SYNERGYTM Coronary Stent System
n=103 Participants
Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Target Vessel Revascularization (TVR) Rate
0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure
SYNERGYTM Coronary Stent System
n=103 Participants
Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Target Vessel Failure (TVF) Rate
0 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure
SYNERGYTM Coronary Stent System
n=103 Participants
Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
0 percentage of participants

Adverse Events

SYNERGYTM Coronary Stent System

Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
SYNERGYTM Coronary Stent System
n=103 participants at risk
Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Metabolism and nutrition disorders
Metabolism and nutrition disorders
0.97%
1/103 • Number of events 1

Other adverse events

Other adverse events
Measure
SYNERGYTM Coronary Stent System
n=103 participants at risk
Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Cardiac disorders
Cardiac disorders
1.9%
2/103 • Number of events 2
General disorders
General disorders and administration site conditions
4.9%
5/103 • Number of events 5

Additional Information

Dr Hanyaling

The General Hospital of ShenYang Military

Phone: 02428851876

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60