Trial Outcomes & Findings for PROMUS Element Japan Small Vessel Trial (NCT NCT01080261)
NCT ID: NCT01080261
Last Updated: 2016-03-29
Results Overview
A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event.
COMPLETED
PHASE3
60 participants
9 months
2016-03-29
Participant Flow
Enrollment of 60 patients was planned and 60 patients were enrolled at 14 sites in Japan from February 8, 2010 to June 15, 2010.
Participant milestones
| Measure |
PROMUS Element
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PROMUS Element Japan Small Vessel Trial
Baseline characteristics by cohort
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=5 Participants
|
|
Age, Continuous
|
69.20 years
STANDARD_DEVIATION 9.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
60 participants
n=5 Participants
|
|
Comorbidities
History of Peripheral Vascular Disease
|
5 participant
n=5 Participants
|
|
Comorbidities
History of Transient Ischemic Attack
|
1 participant
n=5 Participants
|
|
Comorbidities
History of Cerebrovascular Accident
|
11 participant
n=5 Participants
|
|
Comorbidities
History of Renal Disease
|
10 participant
n=5 Participants
|
|
Comorbidities
History of Gastrointestinal Bleeding
|
0 participant
n=5 Participants
|
|
Cardiac History
Previous Percutaneous Coronary Intervention (PCI)
|
40 participants
n=5 Participants
|
|
Cardiac History
Previous Coronary Artery Bypass Graft (CABG)
|
1 participants
n=5 Participants
|
|
Cardiac History
Previous Myocardial Infarction (MI)
|
16 participants
n=5 Participants
|
|
Cardiac History
Congestive Heart Failure
|
6 participants
n=5 Participants
|
|
Cardiac History
Stable Angina
|
43 participants
n=5 Participants
|
|
Cardiac History
Unstable Angina
|
8 participants
n=5 Participants
|
|
Cardiac History
Silent Ischemia
|
12 participants
n=5 Participants
|
|
Cardiac History: Left Ventricular Ejection Fraction
|
63.27 percent
STANDARD_DEVIATION 10.35 • n=5 Participants
|
|
Cardiac Risk Factors
Smoking, Ever
|
37 participants
n=5 Participants
|
|
Cardiac Risk Factors
Medically Treated Diabetes
|
22 participants
n=5 Participants
|
|
Cardiac Risk Factors
Hyperlipidemia Requiring Medication
|
46 participants
n=5 Participants
|
|
Cardiac Risk Factors
Hypertension Requiring Medication
|
51 participants
n=5 Participants
|
|
Cardiac Risk Factors
Family History of Coronary Artery Disease
|
13 participants
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Left Anterior Descending Artery
|
24 Lesions
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Left Circumflex Artery
|
20 Lesions
n=5 Participants
|
|
Lesion Characteristic: Target Lesion Vessel
Right Coronary Artery
|
16 Lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Ostial
|
11 lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Proximal
|
23 lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Mid
|
16 lesions
n=5 Participants
|
|
Lesion Characteristic: Lesion Location
Distal
|
10 lesions
n=5 Participants
|
|
Lesion Characteristics
Reference Vessel Diameter
|
2.02 millimeter
STANDARD_DEVIATION 0.26 • n=5 Participants
|
|
Lesion Characteristics
Minimum Lumen Diameter
|
0.56 millimeter
STANDARD_DEVIATION 0.25 • n=5 Participants
|
|
Lesion Characteristics
Lesion Length
|
12.91 millimeter
STANDARD_DEVIATION 5.91 • n=5 Participants
|
|
Lesion Characteristic: Percent Diameter Stenosis
|
72.52 percent stenosis
STANDARD_DEVIATION 11.27 • n=5 Participants
|
|
Lesion Characteristics
Eccentric Lesion
|
34 participants
n=5 Participants
|
|
Lesion Characteristics
> 45 Degree Bend
|
12 participants
n=5 Participants
|
|
Lesion Characteristics
> 90 Degree Bend
|
0 participants
n=5 Participants
|
|
Lesion Characteristics
Tortuosity, any
|
10 participants
n=5 Participants
|
|
Lesion Characteristics
Calcification, any
|
12 participants
n=5 Participants
|
|
Lesion Characteristics
Total Occlusion
|
1 participants
n=5 Participants
|
|
Lesion Characteristics
Bifurcation
|
4 participants
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type A
|
4 lesions
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type B1
|
17 lesions
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type B2
|
27 lesions
n=5 Participants
|
|
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class
Type C
|
12 lesions
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 0
|
0 lesions
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 1
|
1 lesions
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 2
|
3 lesions
n=5 Participants
|
|
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
TIMI 3
|
56 lesions
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
A major adverse cardiac event (MACE) is defined as any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI, Q-wave and non-Q-wave), or cardiac death. Reported as percentage of participants who have experienced a MACE event.
Outcome measures
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB) or troponin above upper limit of normal (ULN) (baseline troponin \<ULN); if no new Q-waves total CK or troponin \>3× ULN (baseline troponin \<ULN) plus at least one of the following: electrocardiogram changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin \>5× ULN
Outcome measures
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Myocardial Infarction (MI) (Percentage of Participants With an Event)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Participants who died from any cause
Outcome measures
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
All-cause Death (Percentage of Participants With an Event)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded. Reported as percentage of participants who experienced cardiac death.
Outcome measures
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Cardiac Death (Percentage of Participants With an Event)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Target vessel revascularization (TVR) is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.Reported as percentage of participants who experienced a TVR.
Outcome measures
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Target Vessel Revascularization (Percentage of Participants With an Event)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.
Target lesion revascularization (TLR) 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. Reported as percentage of participants who experienced a TLR.
Outcome measures
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Target Lesion Revascularization (Percentage of Participants With an Event)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Includes any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. Reported as percentage of participants who experienced a TVF event.
Outcome measures
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Target Vessel Failure (TVF) (Percentage of Participants With an Event)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. Reported as percentage of participants who experienced a TLF event.
Outcome measures
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Target Lesion Failure (TLF) (Percentage of Participants With an Event)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 0-30 Days (Early)Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)
Outcome measures
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: >30 days - 9 monthsPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)
Outcome measures
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: At time of index procedurePopulation: Analysis was intention to treat
Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent
Outcome measures
| Measure |
PROMUS Element
n=60 Stents Implanted
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Technical Success (Percentage of Stents)
|
100.0 percentage of stents
|
SECONDARY outcome
Timeframe: While participant is in the hospitalPopulation: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Expressed as percentage of participants in whom mean lesion diameter stenosis was \<30% with TIMI 3 flow (visually assessed) and who did not experience an occurrence of in-hospital myocardial infarction, target vessel revascularization, or cardiac death.
Outcome measures
| Measure |
PROMUS Element
n=60 Participants
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Clinical Procedural Success (Percentage of Participants)
|
100.0 percentage of participants
|
Adverse Events
PROMUS Element
Serious adverse events
| Measure |
PROMUS Element
n=60 participants at risk
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Cardiac disorders
Cardiac tamponade
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Cardiac disorders
Cardiac failure congestive
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Periodontitis
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Eye disorders
Cataract
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
General disorders
Non-cardiac chest pain
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Hepatobiliary disorders
Bile duct stone
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Infections and infestations
Post procedural infection
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Nervous system disorders
Thalamus haemorrhage
|
1.7%
1/60 • Number of events 1 • 9 months
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • Number of events 1 • 9 months
|
Other adverse events
| Measure |
PROMUS Element
n=60 participants at risk
Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
11.7%
7/60 • Number of events 7 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In Japan, the study agreement was executed between the head of hospital (not PI) and Boston Scientific Japan. The site must get written approval before they publish any study data/information to an outside community such as a scientific society.
- Publication restrictions are in place
Restriction type: OTHER