ClinicalTrials.gov
ClinicalTrials.gov Menu

NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01703000
Recruitment Status : Completed
First Posted : October 10, 2012
Results First Posted : March 21, 2014
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Atherosclerosis
Coronary Artery Disease
Intervention Device: Percutaneous coronary intervention (NG PROMUS)
Enrollment 100
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description

Single-arm treatment group receiving interventional NG PROMUS study stent

Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.

Period Title: Overall Study
Started 100
Completed 99
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description

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 Number of Baseline Participants 100
Hide Baseline Analysis Population Description
Single arm with investigational NG PROMUS Everolimus Eluting Coronary Stent System N=100 patients, N=119 Lesions, N=127 Stents
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
61.72  (9.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
15
  15.0%
Male
85
  85.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
Hispanic or Latino 2
Caucasian 72
Asian 13
Black, of African Heritage 1
Native Hawaiian or Other Pacific Islander 5
Other 6
Not disclosed 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
Singapore 10
Australia 2
New Zealand 88
Cardiac History   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
Previous Percutaneous Coronary Intervention 23
Previous Coronary Artery Bypass Graft 5
Previous Myocardial Infarction 16
Congestive Heart Failure 2
Stable Angina 51
Unstable Angina 25
Silent Ischemia 7
[1]
Measure Description: Note: A single participant could potentially experience multiple categories listed below.
Cardiac Risk Factors   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
Smoking, Ever 56
Medically Treated Diabetes 16
Hyperlipidemia Requiring Medication 78
Hypertension Requiring Medication 70
Family History of Coronary Artery Disease 51
[1]
Measure Description: Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristics: Target Lesion Vessel   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 100 participants
Left Anterior Descending Artery 60
Circumflex Artery 27
Right Coronary Artery 32
[1]
Measure Description: Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristic: Lesion Location   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 100 participants
Ostial 8
Proximal 47
Mid 49
Distal 15
[1]
Measure Description: Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristic: Lesion Length   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 100 participants
Less than or equal to 20 mm 91
Greater than 20 mm 28
[1]
Measure Description: Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristics   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 100 participants
Tortuosity, Any 10
Calcification, Any 35
Ulcerated 3
Aneurysm 2
Bifurcation 61
Total Occlusion 2
Eccentric Lesion 86
[1]
Measure Description: Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 100 participants
0 (no perfusion) 0
1 (penetration with minimal perfusion) 2
2 (partial perfusion) 9
3 (complete perfusion) 108
[1]
Measure Description: Note: A single participant could potentially experience multiple categories listed below.
Lesion Characteristics by Quantitative Cornary Angiography  
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 100 participants
Reference Vessel Diameter 2.78  (0.45)
Minimum Lumen Diameter 0.85  (0.29)
Lesion Length 16.05  (7.14)
Lesion Characteristic: Percent Diameter Stenosis by QCA  
Mean (Standard Deviation)
Unit of measure:  Percent Diameter Stenosis
Number Analyzed 100 participants
69.12  (9.69)
1.Primary Outcome
Title Technical Success Rate
Hide Description 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
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
119
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of lesions
99.2
(95.4 to 100)
2.Secondary Outcome
Title Target Lesion Revascularization (TLR) Rate
Hide Description

Target 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.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
0
3.Secondary Outcome
Title Target Lesion Failure (TLF) Rate
Hide Description

Target 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.

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
2
4.Secondary Outcome
Title Target Vessel Revascularization (TVR) Rate
Hide Description

Target 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.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
0
5.Secondary Outcome
Title Target Vessel Failure (TVF) Rate
Hide Description

Target 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.

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
2
6.Secondary Outcome
Title Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
Hide Description MI 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.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
1
7.Secondary Outcome
Title Cardiac Death Rate
Hide Description

Cardiac 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
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
1
8.Secondary Outcome
Title Non-cardiac Death Rate
Hide Description

Non-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
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
0
9.Secondary Outcome
Title All Death Rate
Hide Description Death is categorized as cardiac or non-cardiac deaths.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
1
10.Secondary Outcome
Title Cardiac Death or MI Rate
Hide Description

Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.

MI definition used was the PLATINUM definition for MI.

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
2
11.Secondary Outcome
Title All Death or MI Rate
Hide Description

Any all-cause mortality event or MI meeting the criteria defined for any death or MI.

MI definition used was the PLATINUM definition for MI.

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
2
12.Secondary Outcome
Title All Death/MI/TVR Rate
Hide Description

Any event meeting the pre-specified criteria for any death, MI, or TVR.

MI definition used was the PLATINUM definition for MI.

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
2
13.Secondary Outcome
Title Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
Hide Description

Stent 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)

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
0
14.Secondary Outcome
Title Clinical Procedural Success Rate
Hide Description

Clinical 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.

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99
(94.6 to 100)
15.Secondary Outcome
Title In-stent Percent Diameter Stenosis (%DS)
Hide Description

As 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.

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
119
Mean (Standard Deviation)
Unit of Measure: In-Stent % Diameter Stenosis
3.86  (8.43)
16.Secondary Outcome
Title In-segment Percent Diameter Stenosis (%DS)
Hide Description

As 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.

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
119
Mean (Standard Deviation)
Unit of Measure: Diameter Stenosis, In-Segment (%)
18.14  (7.9)
17.Secondary Outcome
Title In-stent Minimum Lumen Diameter (MLD)
Hide Description

As 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.

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
119
Mean (Standard Deviation)
Unit of Measure: mm
2.69  (0.43)
18.Secondary Outcome
Title In-segment Minimum Lumen Diameter (MLD)
Hide Description

As 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.

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
119
Mean (Standard Deviation)
Unit of Measure: mm
2.31  (0.46)
19.Secondary Outcome
Title Acute Gain
Hide Description Acute gain, as measured by angiographic core lab
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: mm
1.84  (0.45)
20.Secondary Outcome
Title Vessel Area
Hide Description As measured by IVUS, the mean vessel area (mm2).
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
99
Mean (Standard Deviation)
Unit of Measure: mm^2
15.1  (4.34)
21.Secondary Outcome
Title Stent Area
Hide Description As measured by IVUS, the area of the stent.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
101
Mean (Standard Deviation)
Unit of Measure: mm^2
7.83  (2.38)
22.Secondary Outcome
Title Lumen Area
Hide Description As measured by IVUS, the area of the lumen.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
100
Mean (Standard Deviation)
Unit of Measure: mm^2
7.76  (2.25)
23.Secondary Outcome
Title Vessel Volume
Hide Description As measured by IVUS, the volume of the vessel.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
99
Mean (Standard Deviation)
Unit of Measure: mm^3
354.34  (181.6)
24.Secondary Outcome
Title Stent Volume
Hide Description As measured by IVUS, the volume of the stent.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
101
Mean (Standard Deviation)
Unit of Measure: mm^3
185.3  (91.75)
25.Secondary Outcome
Title Lumen Volume
Hide Description As measured by IVUS, the volume of the lumen.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
100
Mean (Standard Deviation)
Unit of Measure: mm^3
182.6  (87.93)
26.Secondary Outcome
Title Incomplete Apposition
Hide Description

Incomplete 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).

Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
101
Measure Type: Number
Unit of Measure: percentage of lesions
12.9
27.Secondary Outcome
Title Percent Net Volume Obstruction
Hide Description The percentage of volume obstruction, as measured by the IVUS core lab.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
100
Mean (Standard Deviation)
Unit of Measure: % of volume
0  (.01)
28.Secondary Outcome
Title Longitudinal Stent Deformation
Hide Description Longitudinal 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.
Time Frame Participants will be followed for the duration of hospital stay, an expected average of 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description:

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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of stents
0
Time Frame Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NG PROMUS Stent
Hide Arm/Group Description

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-Cause Mortality
NG PROMUS Stent
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NG PROMUS Stent
Affected / at Risk (%) # Events
Total   16/100 (16.00%)    
Cardiac disorders   
Coronary artery dissection  1  4/100 (4.00%)  4
Atrial fibrillation  1  1/100 (1.00%)  1
Cardiac arrest  1  1/100 (1.00%)  1
Coronary artery stenosis  1  1/100 (1.00%)  1
Pericarditis  1  1/100 (1.00%)  1
General disorders   
Non-cardiac chest pain  1  7/100 (7.00%)  7
Infections and infestations   
Pneumonia  1  1/100 (1.00%)  1
Injury, poisoning and procedural complications   
Vascular pseudoaneurysm  1  1/100 (1.00%)  1
Musculoskeletal and connective tissue disorders   
Costochondritis  1  1/100 (1.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
NG PROMUS Stent
Affected / at Risk (%) # Events
Total   27/100 (27.00%)    
Cardiac disorders   
Myocardial infarction  1  16/100 (16.00%)  16
Coronary artery dissection  1  5/100 (5.00%)  5
Bradycardia  1  1/100 (1.00%)  1
Gastrointestinal disorders   
Nausea  1  1/100 (1.00%)  1
General disorders   
Catheter site haematoma  1  3/100 (3.00%)  3
Catheter site haemorrhage  1  1/100 (1.00%)  1
Injury, poisoning and procedural complications   
Procedural hypotension  1  1/100 (1.00%)  1
Skin laceration  1  1/100 (1.00%)  1
Investigations   
Blood urine present  1  1/100 (1.00%)  1
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  1/100 (1.00%)  1
Musculoskeletal pain  1  1/100 (1.00%)  1
Nervous system disorders   
Presyncope  1  2/100 (2.00%)  2
Skin and subcutaneous tissue disorders   
Increased tendency to bruise  1  1/100 (1.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Peter Maurer, Director Clinical Trials
Organization: Boston Scientific
Phone: 508-683-6678
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01703000     History of Changes
Other Study ID Numbers: NG PROMUS Clinical Trial S2294
First Submitted: October 5, 2012
First Posted: October 10, 2012
Results First Submitted: December 16, 2013
Results First Posted: March 21, 2014
Last Update Posted: April 15, 2014