AtherosclerosisNCT01703000
NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions
A study testing Percutaneous coronary intervention (NG PROMUS) in people with Atherosclerosis and Coronary Artery Disease, run by Boston Scientific Corporation at 9 sites in 3 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Coronary Artery Disease
- What is being tested?
- Percutaneous coronary intervention (NG PROMUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Nov 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
New Zealand6 sites
Mercy Angiography Unit, Ltd. Mercy Hospital
Auckland, 1003
Auckland City Hospital
Auckland, 1010
North Shore Hospital
Auckland, 1030
Ascot Angiography
Auckland, 1546
Christchurch
Christchurch, 8140
Middlemore Hospital
Otahuhu, 1640
Singapore2 sites
National University Hospital Singapore
Singapore, 119228
National Heart Center Singapore
Singapore, 168752
About this study
Official title: 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)
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)
Read the 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)
- Conditions
- Atherosclerosis, Coronary Artery Disease
- Being tested
- Percutaneous coronary intervention (NG PROMUS)
- Keywords
- drug eluting coronary stent
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary intervention (NG PROMUS)Device
Interventional coronary artery stenting with NG PROMUS study stent.
| Study group | Role | What they receive |
|---|---|---|
| NG PROMUS stent | Experimental | Single-arm treatment group receiving interventional NG PROMUS study stent Receives: Device: Percutaneous coronary intervention (NG PROMUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John A Ormiston, MBChB, FRACP, FRACR, Principal investigator, Mercy Angiography Unit, Ltd. Mercy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703000
- Sponsor's protocol ID
- NG PROMUS Clinical Trial S2294
- Status last verified
- Mar 2014
- First submitted
- 5 Oct 2012
- Last updated
- 15 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01703000
- Acronym / sponsor ID
- NG PROMUS Clinical Trial S2294
- Conditions
- Atherosclerosis, Coronary Artery Disease
- Keywords
- drug eluting coronary stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 Oct 2012 (estimated)
- Results
- Posted 21 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NG PROMUS stent | Experimental | Device: Percutaneous coronary intervention (NG PROMUS)Single-arm treatment group receiving interventional NG PROMUS study stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary intervention (NG PROMUS)Interventional coronary artery stenting with NG PROMUS study stent. | Device | NG PROMUS stent |
Primary outcome
Technical Success Rate
Time frame: 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
27 secondary outcomes
Target Lesion Revascularization (TLR) Rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Cardiac Death Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Non-cardiac Death Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
All Death Rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Clinical Procedural Success Rate
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
In-stent Percent Diameter Stenosis (%DS)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
In-segment Percent Diameter Stenosis (%DS)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
In-stent Minimum Lumen Diameter (MLD)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
In-segment Minimum Lumen Diameter (MLD)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Acute Gain
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Vessel Area
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Stent Area
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Lumen Area
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Vessel Volume
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Stent Volume
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Lumen Volume
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Incomplete Apposition
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Percent Net Volume Obstruction
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Longitudinal Stent Deformation
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Drug-eluting product information from ManufacturerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Ormiston, MBChB, FRACP, FRACR principal investigator
Mercy Angiography Unit, Ltd. Mercy Hospital
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention (NG PROMUS) in people with Atherosclerosis and Coronary Artery Disease, run by Boston Scientific Corporation at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in New Zealand, Singapore, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success Rate (time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014.