NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions

Study Overview
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Brief Summary
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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
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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)

Official Title
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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)

Conditions
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Atherosclerosis, Coronary Artery Disease

Intervention / Treatment
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* Device: Percutaneous coronary intervention (NG PROMUS)


Participation Criteria
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Eligibility Criteria
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Clinical Inclusion Criteria: Subject must be at least 18 years of age 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 Subject is eligible for percutaneous coronary intervention (PCI) Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia Subject is an acceptable candidate for coronary artery bypass grafting (CABG) Subject is willing to comply with all protocol-required follow-up evaluation Angiographic Inclusion Criteria: 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 Target lesion(s) length must be ≤34 mm (by visual estimate) 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 Coronary anatomy is likely to allow delivery of a study device to the target lesions(s) 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: Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI) Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina Subject has received an organ transplant or is on a waiting list for an organ transplant Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure Planned PCI (including staged procedures) or CABG after the index procedure Subject previously treated at any time with intravascular brachytherapy 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) 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 Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3 Subject has a white blood cell (WBC) count < 3,000 cells/mm3 Subject has documented or suspected liver disease, including laboratory evidence of hepatitis Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L) Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure 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) 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 Exclusion Criteria: Planned treatment of more than 3 lesions. Planned treatment of lesions in more than 2 major epicardial vessels Planned treatment of a single lesion with more than 1 stent Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) Target lesion(s) is located in the left main Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate. Target lesion(s) is located within a saphenous vein graft or an arterial graft Target lesion(s) will be accessed via a saphenous vein graft or arterial graft Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent) Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent Subject has unprotected left main coronary artery disease (>50% diameter stenosis) Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NG PROMUS stent<br>Single-arm treatment group receiving interventional NG PROMUS study stent | Device: Percutaneous coronary intervention (NG PROMUS)<br>* Interventional coronary artery stenting with NG PROMUS study stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| 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 | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| 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 | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| All Death Rate | Death is categorized as cardiac or non-cardiac deaths. | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| 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) | Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Acute Gain | Acute gain, as measured by angiographic core lab | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Vessel Area | As measured by IVUS, the mean vessel area (mm2). | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Stent Area | As measured by IVUS, the area of the stent. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Lumen Area | As measured by IVUS, the area of the lumen. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Vessel Volume | As measured by IVUS, the volume of the vessel. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Stent Volume | As measured by IVUS, the volume of the stent. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Lumen Volume | As measured by IVUS, the volume of the lumen. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| 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). | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Percent Net Volume Obstruction | The percentage of volume obstruction, as measured by the IVUS core lab. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting coronary stent