Trial Outcomes & Findings for NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions (NCT NCT01703000)
NCT ID: NCT01703000
Last Updated: 2014-04-15
Results Overview
Technical success is 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
COMPLETED
NA
100 participants
Participants will be followed for the duration of hospital stay, an expected average of 1 day
2014-04-15
Participant Flow
Recruitment of subjects for NG PROMUS study started on November 20, 2012 and completed on March 12, 2013. Subjects were recruited at 9 investigational centers in Australia, New Zealand and Singapore.
Participant milestones
| Measure |
NG PROMUS Stent
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
NG PROMUS Stent
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions
Baseline characteristics by cohort
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Age, Customized
|
61.72 years
STANDARD_DEVIATION 9.73 • n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
72 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage
|
1 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
5 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Not disclosed
|
1 participants
n=93 Participants
|
|
Region of Enrollment
Singapore
|
10 participants
n=93 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=93 Participants
|
|
Region of Enrollment
New Zealand
|
88 participants
n=93 Participants
|
|
Cardiac History
Previous Percutaneous Coronary Intervention
|
23 participants
n=93 Participants
|
|
Cardiac History
Previous Coronary Artery Bypass Graft
|
5 participants
n=93 Participants
|
|
Cardiac History
Previous Myocardial Infarction
|
16 participants
n=93 Participants
|
|
Cardiac History
Congestive Heart Failure
|
2 participants
n=93 Participants
|
|
Cardiac History
Stable Angina
|
51 participants
n=93 Participants
|
|
Cardiac History
Unstable Angina
|
25 participants
n=93 Participants
|
|
Cardiac History
Silent Ischemia
|
7 participants
n=93 Participants
|
|
Cardiac Risk Factors
Smoking, Ever
|
56 participants
n=93 Participants
|
|
Cardiac Risk Factors
Medically Treated Diabetes
|
16 participants
n=93 Participants
|
|
Cardiac Risk Factors
Hyperlipidemia Requiring Medication
|
78 participants
n=93 Participants
|
|
Cardiac Risk Factors
Hypertension Requiring Medication
|
70 participants
n=93 Participants
|
|
Cardiac Risk Factors
Family History of Coronary Artery Disease
|
51 participants
n=93 Participants
|
|
Lesion Characteristics: Target Lesion Vessel
Left Anterior Descending Artery
|
60 Lesions
n=93 Participants
|
|
Lesion Characteristics: Target Lesion Vessel
Circumflex Artery
|
27 Lesions
n=93 Participants
|
|
Lesion Characteristics: Target Lesion Vessel
Right Coronary Artery
|
32 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Location
Ostial
|
8 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Location
Proximal
|
47 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Location
Mid
|
49 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Location
Distal
|
15 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Length
Less than or equal to 20 mm
|
91 Lesions
n=93 Participants
|
|
Lesion Characteristic: Lesion Length
Greater than 20 mm
|
28 Lesions
n=93 Participants
|
|
Lesion Characteristics
Tortuosity, Any
|
10 Lesions
n=93 Participants
|
|
Lesion Characteristics
Calcification, Any
|
35 Lesions
n=93 Participants
|
|
Lesion Characteristics
Ulcerated
|
3 Lesions
n=93 Participants
|
|
Lesion Characteristics
Aneurysm
|
2 Lesions
n=93 Participants
|
|
Lesion Characteristics
Bifurcation
|
61 Lesions
n=93 Participants
|
|
Lesion Characteristics
Total Occlusion
|
2 Lesions
n=93 Participants
|
|
Lesion Characteristics
Eccentric Lesion
|
86 Lesions
n=93 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
0 (no perfusion)
|
0 Lesions
n=93 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
1 (penetration with minimal perfusion)
|
2 Lesions
n=93 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
2 (partial perfusion)
|
9 Lesions
n=93 Participants
|
|
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow
3 (complete perfusion)
|
108 Lesions
n=93 Participants
|
|
Lesion Characteristics by Quantitative Cornary Angiography
Reference Vessel Diameter
|
2.78 Millimeters
STANDARD_DEVIATION 0.45 • n=93 Participants
|
|
Lesion Characteristics by Quantitative Cornary Angiography
Minimum Lumen Diameter
|
0.85 Millimeters
STANDARD_DEVIATION 0.29 • n=93 Participants
|
|
Lesion Characteristics by Quantitative Cornary Angiography
Lesion Length
|
16.05 Millimeters
STANDARD_DEVIATION 7.14 • n=93 Participants
|
|
Lesion Characteristic: Percent Diameter Stenosis by QCA
|
69.12 Percent Diameter Stenosis
STANDARD_DEVIATION 9.69 • n=93 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayTechnical success is 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
| Measure |
NG PROMUS Stent
n=119 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Technical Success Rate
|
99.2 percentage of lesions
Interval 95.4 to 100.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysTarget 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. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is \>/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following: * The subject has a positive functional study corresponding to the area served by the target lesion. * The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel. * The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is \>/= 70% by QCA even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Target Lesion Revascularization (TLR) Rate
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysTarget 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. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF. The MI definition used for Target Lesion Failure was the PLATINUM MI definition.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Target Lesion Failure (TLF) Rate
|
2 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysTarget vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis \>/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is \>/= 50% by QCA and any of the following are present: * The subject has a positive functional study corresponding to the area served by the target vessel. * The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel. * The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is \>/=70% even in the absence of clinical or functional ischemia.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Target Vessel Revascularization (TVR) Rate
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysTarget vessel failure is any ischemia-driven revascularization of the target vessel, 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. The MI definition used was the PLATINUM MI definition.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Target Vessel Failure (TVF) Rate
|
2 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysMI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
|
1 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysCardiac death is defined as death due to any of the following. * Acute MI * Cardiac perforation/pericardial tamponade * Arrhythmia or conduction abnormality * CVA through hospital discharge or CVA suspected of being related to the procedure * Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery * Any death in which a cardiac cause cannot be excluded
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Cardiac Death Rate
|
1 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysNon-cardiac death is defined as a death not due to any of the following: * Acute MI * Cardiac perforation/pericardial tamponade * Arrhythmia or conduction abnormality * CVA through hospital discharge or CVA suspected of being related to the procedure * Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery * Any death in which a cardiac cause cannot be excluded
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Non-cardiac Death Rate
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysDeath is categorized as cardiac or non-cardiac deaths.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
All Death Rate
|
1 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysAny cardiac death or MI event meeting the criteria defined for a cardiac death or MI. MI definition used was the PLATINUM definition for MI.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Cardiac Death or MI Rate
|
2 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysAny all-cause mortality event or MI meeting the criteria defined for any death or MI. MI definition used was the PLATINUM definition for MI.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
All Death or MI Rate
|
2 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysAny event meeting the pre-specified criteria for any death, MI, or TVR. MI definition used was the PLATINUM definition for MI.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
All Death/MI/TVR Rate
|
2 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 daysStent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab. Timing: * Acute stent thrombosis\*: 0 24 hours after stent implantation * Subacute stent thrombosis\*: \>24 hours to 30 days after stent implantation * Late stent thrombosis: \>30 days to 1 year after stent implantation * Very late stent thrombosis: \>1 year after stent implantation \* Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days. Stent thrombosis may be defined as: * Confirmed/definite * Probable * Possible Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayClinical procedural success is post-procedure diameter stenosis \<30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death. MI definition used was the PLATINUM definition for MI.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Clinical Procedural Success Rate
|
99 percentage of participants
Interval 94.6 to 100.0
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayAs measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region. Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-\[Minimum Lumen Diameter/Reference diameter\]) x 100.
Outcome measures
| Measure |
NG PROMUS Stent
n=119 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
In-stent Percent Diameter Stenosis (%DS)
|
3.86 In-Stent % Diameter Stenosis
Standard Deviation 8.43
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayAs measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions). Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-\[Minimum Lumen Diameter/Reference diameter\]) x 100.
Outcome measures
| Measure |
NG PROMUS Stent
n=119 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
In-segment Percent Diameter Stenosis (%DS)
|
18.14 Diameter Stenosis, In-Segment (%)
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayAs measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region. The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.
Outcome measures
| Measure |
NG PROMUS Stent
n=119 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
In-stent Minimum Lumen Diameter (MLD)
|
2.69 mm
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayAs measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions). The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.
Outcome measures
| Measure |
NG PROMUS Stent
n=119 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
In-segment Minimum Lumen Diameter (MLD)
|
2.31 mm
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayAcute gain, as measured by angiographic core lab
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Acute Gain
|
1.84 mm
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayAs measured by IVUS, the mean vessel area (mm2).
Outcome measures
| Measure |
NG PROMUS Stent
n=99 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Vessel Area
|
15.1 mm^2
Standard Deviation 4.34
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayAs measured by IVUS, the area of the stent.
Outcome measures
| Measure |
NG PROMUS Stent
n=101 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Stent Area
|
7.83 mm^2
Standard Deviation 2.38
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayAs measured by IVUS, the area of the lumen.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Lumen Area
|
7.76 mm^2
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayAs measured by IVUS, the volume of the vessel.
Outcome measures
| Measure |
NG PROMUS Stent
n=99 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Vessel Volume
|
354.34 mm^3
Standard Deviation 181.6
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayAs measured by IVUS, the volume of the stent.
Outcome measures
| Measure |
NG PROMUS Stent
n=101 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Stent Volume
|
185.3 mm^3
Standard Deviation 91.75
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayAs measured by IVUS, the volume of the lumen.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Lumen Volume
|
182.6 mm^3
Standard Deviation 87.93
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayIncomplete apposition rate, as measured by the IVUS core lab. Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS).
Outcome measures
| Measure |
NG PROMUS Stent
n=101 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Incomplete Apposition
|
12.9 percentage of lesions
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayThe percentage of volume obstruction, as measured by the IVUS core lab.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Lesions
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Percent Net Volume Obstruction
|
0 % of volume
Standard Deviation .01
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 dayLongitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.
Outcome measures
| Measure |
NG PROMUS Stent
n=100 Participants
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Longitudinal Stent Deformation
|
0 percentage of stents
|
Adverse Events
NG PROMUS Stent
Serious adverse events
| Measure |
NG PROMUS Stent
n=100 participants at risk
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Cardiac disorders
Coronary artery dissection
|
4.0%
4/100 • Number of events 4 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Cardiac disorders
Pericarditis
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
General disorders
Non-cardiac chest pain
|
7.0%
7/100 • Number of events 7 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Infections and infestations
Pneumonia
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
Other adverse events
| Measure |
NG PROMUS Stent
n=100 participants at risk
Single-arm treatment group receiving interventional NG PROMUS study stent
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
16.0%
16/100 • Number of events 16 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Cardiac disorders
Coronary artery dissection
|
5.0%
5/100 • Number of events 5 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
General disorders
Catheter site haematoma
|
3.0%
3/100 • Number of events 3 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Nervous system disorders
Presyncope
|
2.0%
2/100 • Number of events 2 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Cardiac disorders
Bradycardia
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
General disorders
Catheter site haemorrhage
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Investigations
Blood urine present
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
1.0%
1/100 • Number of events 1 • Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
|
Additional Information
Peter Maurer, Director Clinical Trials
Boston Scientific
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Investigator shall have the right to publish the results, provided that before publishing, Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER