Atherosclerosis, Coronary Artery Disease
Conditions
Keywords
drug eluting coronary stent
Brief summary
NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of Atherosclerotic Lesion(s)
Detailed description
To evaluate clinical and peri-procedural angiographic and intravascular ultrasound (IVUS) outcomes for the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS Stent System) in the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥ 2.50 mm to ≤ 4.0 mm in diameter (by visual estimate)
Interventions
DEVICEPercutaneous coronary intervention (NG PROMUS)
Interventional coronary artery stenting with NG PROMUS study stent.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Subject must be at least 18 years of age 2. Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed 3. Subject is eligible for percutaneous coronary intervention (PCI) 4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia 5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG) 6. Subject is willing to comply with all protocol-required follow-up evaluation Angiographic Inclusion Criteria: 1. Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤4.0 mm 2. Target lesion(s) length must be ≤34 mm (by visual estimate) 3. Target lesion(s) must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1 and one of the following (stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress test or imaging stress test, or elevated biomarkers) prior to procedure 4. Coronary anatomy is likely to allow delivery of a study device to the target lesions(s) 5. The first lesion treated must be successfully pre-dilated/pretreated Note: Successful pre-dilatation/pretreatment refers to dilatation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C. Clinical
Exclusion criteria
1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI) 2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina 3. Subject has received an organ transplant or is on a waiting list for an organ transplant 4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure 5. Planned PCI (including staged procedures) or CABG after the index procedure 6. Subject previously treated at any time with intravascular brachytherapy 7. Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin) 8. Subject has one of the following (as assessed prior to the index procedure):Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months; Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.);Planned procedure that may cause non-compliance with the protocol or confound data interpretation 9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome 10. Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 11. Subject has a white blood cell (WBC) count \< 3,000 cells/mm3 12. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis 13. Subject is on dialysis or has baseline serum creatinine level \>2.0 mg/dL (177µmol/L) 14. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions 15. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months 16. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding 17. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure 18. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint 19. Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure 20. Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure) 21. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential) Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Revascularization (TLR) Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 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. |
| Target Lesion Failure (TLF) Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 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. |
| Target Vessel Revascularization (TVR) Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 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. |
| Target Vessel Failure (TVF) Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 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. |
| Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 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. |
| Non-cardiac Death Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 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 |
| All Death Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | Death is categorized as cardiac or non-cardiac deaths. |
| Cardiac Death or MI Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 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. |
| All Death or MI Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 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. |
| All Death/MI/TVR Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | Any event meeting the pre-specified criteria for any death, MI, or TVR. MI definition used was the PLATINUM definition for MI. |
| Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions) | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 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) |
| Clinical Procedural Success Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 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. |
| In-stent Percent Diameter Stenosis (%DS) | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 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. |
| Cardiac Death Rate | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 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 |
| In-stent Minimum Lumen Diameter (MLD) | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 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. |
| In-segment Minimum Lumen Diameter (MLD) | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 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. |
| Acute Gain | Participants will be followed for the duration of hospital stay, an expected average of 1 day | Acute gain, as measured by angiographic core lab |
| Vessel Area | Participants will be followed for the duration of hospital stay, an expected average of 1 day | As measured by IVUS, the mean vessel area (mm2). |
| Stent Area | Participants will be followed for the duration of hospital stay, an expected average of 1 day | As measured by IVUS, the area of the stent. |
| Lumen Area | Participants will be followed for the duration of hospital stay, an expected average of 1 day | As measured by IVUS, the area of the lumen. |
| Vessel Volume | Participants will be followed for the duration of hospital stay, an expected average of 1 day | As measured by IVUS, the volume of the vessel. |
| Stent Volume | Participants will be followed for the duration of hospital stay, an expected average of 1 day | As measured by IVUS, the volume of the stent. |
| Lumen Volume | Participants will be followed for the duration of hospital stay, an expected average of 1 day | As measured by IVUS, the volume of the lumen. |
| Incomplete Apposition | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 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). |
| Percent Net Volume Obstruction | Participants will be followed for the duration of hospital stay, an expected average of 1 day | The percentage of volume obstruction, as measured by the IVUS core lab. |
| Longitudinal Stent Deformation | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 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. |
| In-segment Percent Diameter Stenosis (%DS) | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 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. |
Countries
Australia, New Zealand, Singapore
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | NG PROMUS Stent |
|---|---|
| Age, Customized | 61.72 years STANDARD_DEVIATION 9.73 |
| Cardiac History Congestive Heart Failure | 2 participants |
| Cardiac History Previous Coronary Artery Bypass Graft | 5 participants |
| Cardiac History Previous Myocardial Infarction | 16 participants |
| Cardiac History Previous Percutaneous Coronary Intervention | 23 participants |
| Cardiac History Silent Ischemia | 7 participants |
| Cardiac History Stable Angina | 51 participants |
| Cardiac History Unstable Angina | 25 participants |
| Cardiac Risk Factors Family History of Coronary Artery Disease | 51 participants |
| Cardiac Risk Factors Hyperlipidemia Requiring Medication | 78 participants |
| Cardiac Risk Factors Hypertension Requiring Medication | 70 participants |
| Cardiac Risk Factors Medically Treated Diabetes | 16 participants |
| Cardiac Risk Factors Smoking, Ever | 56 participants |
| Lesion Characteristic: Lesion Length Greater than 20 mm | 28 Lesions |
| Lesion Characteristic: Lesion Length Less than or equal to 20 mm | 91 Lesions |
| Lesion Characteristic: Lesion Location Distal | 15 Lesions |
| Lesion Characteristic: Lesion Location Mid | 49 Lesions |
| Lesion Characteristic: Lesion Location Ostial | 8 Lesions |
| Lesion Characteristic: Lesion Location Proximal | 47 Lesions |
| Lesion Characteristic: Percent Diameter Stenosis by QCA | 69.12 Percent Diameter Stenosis STANDARD_DEVIATION 9.69 |
| Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 0 (no perfusion) | 0 Lesions |
| Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 1 (penetration with minimal perfusion) | 2 Lesions |
| Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 2 (partial perfusion) | 9 Lesions |
| Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow 3 (complete perfusion) | 108 Lesions |
| Lesion Characteristics Aneurysm | 2 Lesions |
| Lesion Characteristics Bifurcation | 61 Lesions |
| Lesion Characteristics Calcification, Any | 35 Lesions |
| Lesion Characteristics Eccentric Lesion | 86 Lesions |
| Lesion Characteristics Tortuosity, Any | 10 Lesions |
| Lesion Characteristics Total Occlusion | 2 Lesions |
| Lesion Characteristics Ulcerated | 3 Lesions |
| Lesion Characteristics by Quantitative Cornary Angiography Lesion Length | 16.05 Millimeters STANDARD_DEVIATION 7.14 |
| Lesion Characteristics by Quantitative Cornary Angiography Minimum Lumen Diameter | 0.85 Millimeters STANDARD_DEVIATION 0.29 |
| Lesion Characteristics by Quantitative Cornary Angiography Reference Vessel Diameter | 2.78 Millimeters STANDARD_DEVIATION 0.45 |
| Lesion Characteristics: Target Lesion Vessel Circumflex Artery | 27 Lesions |
| Lesion Characteristics: Target Lesion Vessel Left Anterior Descending Artery | 60 Lesions |
| Lesion Characteristics: Target Lesion Vessel Right Coronary Artery | 32 Lesions |
| Race/Ethnicity, Customized Asian | 13 participants |
| Race/Ethnicity, Customized Black, of African Heritage | 1 participants |
| Race/Ethnicity, Customized Caucasian | 72 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 5 participants |
| Race/Ethnicity, Customized Not disclosed | 1 participants |
| Race/Ethnicity, Customized Other | 6 participants |
| Region of Enrollment Australia | 2 participants |
| Region of Enrollment New Zealand | 88 participants |
| Region of Enrollment Singapore | 10 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 100 |
| serious Total, serious adverse events | 16 / 100 |
Outcome results
Primary
Technical Success Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Technical Success Rate | 99.2 percentage of lesions |
Secondary
Acute Gain
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | Acute Gain | 1.84 mm | Standard Deviation 0.45 |
Secondary
All Death/MI/TVR Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | All Death/MI/TVR Rate | 2 percentage of participants |
Secondary
All Death or MI Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | All Death or MI Rate | 2 percentage of participants |
Secondary
All Death Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | All Death Rate | 1 percentage of participants |
Secondary
Cardiac Death or MI Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Cardiac Death or MI Rate | 2 percentage of participants |
Secondary
Cardiac Death Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Cardiac Death Rate | 1 percentage of participants |
Secondary
Clinical Procedural Success Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Clinical Procedural Success Rate | 99 percentage of participants |
Secondary
Incomplete Apposition
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Incomplete Apposition | 12.9 percentage of lesions |
Secondary
In-segment Minimum Lumen Diameter (MLD)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | In-segment Minimum Lumen Diameter (MLD) | 2.31 mm | Standard Deviation 0.46 |
Secondary
In-segment Percent Diameter Stenosis (%DS)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | In-segment Percent Diameter Stenosis (%DS) | 18.14 Diameter Stenosis, In-Segment (%) | Standard Deviation 7.9 |
Secondary
In-stent Minimum Lumen Diameter (MLD)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | In-stent Minimum Lumen Diameter (MLD) | 2.69 mm | Standard Deviation 0.43 |
Secondary
In-stent Percent Diameter Stenosis (%DS)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | In-stent Percent Diameter Stenosis (%DS) | 3.86 In-Stent % Diameter Stenosis | Standard Deviation 8.43 |
Secondary
Longitudinal Stent Deformation
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Longitudinal Stent Deformation | 0 percentage of stents |
Secondary
Lumen Area
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | Lumen Area | 7.76 mm^2 | Standard Deviation 2.25 |
Secondary
Lumen Volume
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | Lumen Volume | 182.6 mm^3 | Standard Deviation 87.93 |
Secondary
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate | 1 percentage of participants |
Secondary
Non-cardiac Death Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Non-cardiac Death Rate | 0 percentage of participants |
Secondary
Percent Net Volume Obstruction
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | Percent Net Volume Obstruction | 0 % of volume | Standard Deviation 0.01 |
Secondary
Stent Area
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | Stent Area | 7.83 mm^2 | Standard Deviation 2.38 |
Secondary
Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions) | 0 percentage of participants |
Secondary
Stent Volume
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | Stent Volume | 185.3 mm^3 | Standard Deviation 91.75 |
Secondary
Target Lesion Failure (TLF) Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Target Lesion Failure (TLF) Rate | 2 percentage of participants |
Secondary
Target Lesion Revascularization (TLR) Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Target Lesion Revascularization (TLR) Rate | 0 percentage of participants |
Secondary
Target Vessel Failure (TVF) Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Target Vessel Failure (TVF) Rate | 2 percentage of participants |
Secondary
Target Vessel Revascularization (TVR) Rate
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NG PROMUS Stent | Target Vessel Revascularization (TVR) Rate | 0 percentage of participants |
Secondary
Vessel Area
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | Vessel Area | 15.1 mm^2 | Standard Deviation 4.34 |
Secondary
Vessel Volume
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NG PROMUS Stent | Vessel Volume | 354.34 mm^3 | Standard Deviation 181.6 |