Trial Outcomes & Findings for The EVOLVE China Clinical Trial (NCT NCT01966159)
NCT ID: NCT01966159
Last Updated: 2023-11-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
412 participants
Primary outcome timeframe
at 9 months post-index procedure.
Results posted on
2023-11-15
Participant Flow
412 subjects have enrolled and finished at 07Jul2014
Participant milestones
| Measure |
SYNERGY Investigational Device (Test)
SYNERGY Investigational Device (Test): percutaneous coronary intervention
|
PROMUS Element Plus Investigational Device (Control)
PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
|
|---|---|---|
|
Overall Study
STARTED
|
205
|
207
|
|
Overall Study
COMPLETED
|
205
|
207
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The EVOLVE China Clinical Trial
Baseline characteristics by cohort
| Measure |
SYNERGY Investigational Device (Test)
n=205 Participants
SYNERGY Investigational Device (Test): percutaneous coronary intervention
|
PROMUS Element Plus Investigational Device (Control)
n=207 Participants
PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
|
Total
n=412 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.41 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
57.89 years
STANDARD_DEVIATION 9.19 • n=7 Participants
|
58.15 years
STANDARD_DEVIATION 8.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
205 participants
n=5 Participants
|
207 participants
n=7 Participants
|
412 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 9 months post-index procedure.Outcome measures
| Measure |
SYNERGY Investigational Device (Test)
n=205 Participants
SYNERGY Investigational Device (Test): percutaneous coronary intervention
|
PROMUS Element Plus Investigational Device (Control)
n=207 Participants
PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
|
|---|---|---|
|
The In-stent Late Loss Measured by Quantitative Coronary Angiography
|
0.20 mm
Standard Deviation 0.33
|
0.17 mm
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: 12 months post-index procedureTarget lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Outcome measures
| Measure |
SYNERGY Investigational Device (Test)
n=205 Participants
SYNERGY Investigational Device (Test): percutaneous coronary intervention
|
PROMUS Element Plus Investigational Device (Control)
n=207 Participants
PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
|
|---|---|---|
|
Target Lesion Revascularization (TLR) Rate
|
2.0 percentage of participants
|
2.9 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months post-index procedureTarget lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non-Q-wave) related to the target vessel, or (cardiac) death.
Outcome measures
| Measure |
SYNERGY Investigational Device (Test)
n=205 Participants
SYNERGY Investigational Device (Test): percutaneous coronary intervention
|
PROMUS Element Plus Investigational Device (Control)
n=207 Participants
PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
|
|---|---|---|
|
Target Lesion Failure (TLF) Rate
|
4.0 percentage of participants
|
4.4 percentage of participants
|
Adverse Events
SYNERGY Investigational Device (Test)
Serious events: 38 serious events
Other events: 66 other events
Deaths: 0 deaths
PROMUS Element Plus Investigational Device (Control)
Serious events: 27 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SYNERGY Investigational Device (Test)
n=205 participants at risk
SYNERGY Investigational Device (Test): percutaneous coronary intervention
|
PROMUS Element Plus Investigational Device (Control)
n=207 participants at risk
PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
2.4%
5/205 • Number of events 7 • 12 month
|
2.4%
5/207 • Number of events 5 • 12 month
|
|
General disorders
chest discomfort
|
0.98%
2/205 • Number of events 3 • 12 month
|
0.00%
0/207 • 12 month
|
|
Nervous system disorders
cerebral ischaemia
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Gastrointestinal disorders
gastritis
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Vascular disorders
aortic intramural haematoma
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Cardiac disorders
coronary artery stenosis
|
1.5%
3/205 • Number of events 3 • 12 month
|
1.4%
3/207 • Number of events 3 • 12 month
|
|
Cardiac disorders
mycardial infarction
|
1.5%
3/205 • Number of events 3 • 12 month
|
0.00%
0/207 • 12 month
|
|
Cardiac disorders
arteriosclerosis coronary artery
|
0.98%
2/205 • Number of events 2 • 12 month
|
0.00%
0/207 • 12 month
|
|
Cardiac disorders
coronary artery dissection
|
0.98%
2/205 • Number of events 2 • 12 month
|
0.97%
2/207 • Number of events 2 • 12 month
|
|
Cardiac disorders
coronary artery disease
|
0.49%
1/205 • Number of events 1 • 12 month
|
1.9%
4/207 • Number of events 4 • 12 month
|
|
Cardiac disorders
angina pectoris
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Cardiac disorders
atriventricular block second degree
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Cardiac disorders
cardiac failure
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Cardiac disorders
intracardiac thrombus
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Cardiac disorders
ventricular arthythmia
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Cardiac disorders
coronary artery occlusion
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Cardiac disorders
coronary artery thrombosis
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Cardiac disorders
tachycardia
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Cardiac disorders
ventricular tachycardia
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
General disorders
non-cardiac chest pain
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
General disorders
oedema peripheral
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
General disorders
pyrexia
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Nervous system disorders
ischaemic stroke
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Nervous system disorders
tension headache
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Nervous system disorders
cerebral haemorrhage
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Nervous system disorders
dizziness
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Gastrointestinal disorders
gastrointestinal haemorrhage
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Gastrointestinal disorders
gastrooesophageeal reflux disease
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Gastrointestinal disorders
colonic polyp
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Vascular disorders
arteriosclerosis
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Vascular disorders
hypertension
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung neoplasm maligant
|
0.98%
2/205 • Number of events 2 • 12 month
|
0.00%
0/207 • 12 month
|
|
Ear and labyrinth disorders
sudden hearing loss
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Infections and infestations
gastroenteritis
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Infections and infestations
pneumonia
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Injury, poisoning and procedural complications
plague shift
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Eye disorders
vitreous haemorrhage
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Investigations
blood glucose icreased
|
0.49%
1/205 • Number of events 1 • 12 month
|
0.00%
0/207 • 12 month
|
|
Renal and urinary disorders
glycosuria
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Renal and urinary disorders
haematuria
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Renal and urinary disorders
nephrolithiasis
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Renal and urinary disorders
nephrotic syndrome
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Renal and urinary disorders
renal failure chronic
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Metabolism and nutrition disorders
diabetes mellitus
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
0.00%
0/205 • 12 month
|
0.48%
1/207 • Number of events 1 • 12 month
|
Other adverse events
| Measure |
SYNERGY Investigational Device (Test)
n=205 participants at risk
SYNERGY Investigational Device (Test): percutaneous coronary intervention
|
PROMUS Element Plus Investigational Device (Control)
n=207 participants at risk
PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
|
|---|---|---|
|
Cardiac disorders
angina pectoria
|
8.3%
17/205 • Number of events 17 • 12 month
|
4.8%
10/207 • Number of events 12 • 12 month
|
|
Cardiac disorders
others
|
3.4%
7/205 • Number of events 9 • 12 month
|
4.8%
10/207 • Number of events 12 • 12 month
|
|
General disorders
others
|
20.5%
42/205 • 12 month
|
19.3%
40/207 • 12 month
|
Additional Information
Dr. Hanyaling
Shenyang Northern Hospital (The General Hospital of Shenyang Military Region)
Phone: 024-28897310
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60