Trial Outcomes & Findings for PE PREMIER CHINA CLINICAL TRIAL (NCT NCT02230254)

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

101 participants

Primary outcome timeframe

Participants will be followed for the duration of hospital stay, an expected average of 1 day

Results posted on

2022-05-12

Participant Flow

Total Started: 101

Participant milestones

Participant milestones
Measure	PROMUS POREMIER Stent Single-arm treatment group receiving interventional PROMUS PRIMIER study stent Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER
Overall Study STARTED	101
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	PROMUS POREMIER Stent Single-arm treatment group receiving interventional PROMUS PRIMIER study stent Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER
Overall Study Lost to Follow-up	3

Baseline Characteristics

PE PREMIER CHINA CLINICAL TRIAL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PROMUS POREMIER Stent n=101 Participants Single-arm treatment group receiving interventional PROMUS PRIMIER study stent Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER
Age, Continuous	61.47 Year STANDARD_DEVIATION 9.27 • n=93 Participants
Sex: Female, Male Female	24 Participants n=93 Participants
Sex: Female, Male Male	77 Participants n=93 Participants

PRIMARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 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	PROMUS POREMIER Stent n=101 Participants Single-arm treatment group receiving interventional PROMUS PRIMIER study stent Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER
Technical Success Rate	99.1 percentage of participants

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6month and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

as measured by angiographic core lab, change from baseline for target lesions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months

Outcome measures

Outcome data not reported

Adverse Events

PROMUS POREMIER Stent

Serious events: 8 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PROMUS POREMIER Stent n=101 participants at risk Single-arm treatment group receiving interventional PROMUS PRIMIER study stent Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER
Cardiac disorders Angina pectoris	3.0% 3/101 • Number of events 4
Cardiac disorders Angina unstable	0.99% 1/101 • Number of events 1
Cardiac disorders Atrial fibrillation	0.99% 1/101 • Number of events 1
Cardiac disorders Intracardiac thrombus	0.99% 1/101 • Number of events 1
Cardiac disorders Ventricular extrasystoles	0.99% 1/101 • Number of events 1
General disorders Non-cardiac chest pain	0.99% 1/101 • Number of events 1
Metabolism and nutrition disorders Diabetes mellitus	0.99% 1/101 • Number of events 1
Nervous system disorders Subarachnoid haemorrhage	0.99% 1/101 • Number of events 1

Other adverse events

Other adverse events
Measure	PROMUS POREMIER Stent n=101 participants at risk Single-arm treatment group receiving interventional PROMUS PRIMIER study stent Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER
Cardiac disorders Angina pectoris	8.9% 9/101 • Number of events 9
Cardiac disorders Angina unstable	0.99% 1/101 • Number of events 1
Cardiac disorders Coronary artery dissection	0.99% 1/101 • Number of events 1
Gastrointestinal disorders Gingival bleeding	0.99% 1/101 • Number of events 1
Investigations Blood creatine phosphokinase increased	0.99% 1/101 • Number of events 1

Additional Information

Dr. Wang Jian'an

Second Affiliated Hospital of Zhejiang University

Phone: 010-85216440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place