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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01703000




Registration number
NCT01703000
Ethics application status
Date submitted
5/10/2012
Date registered
10/10/2012
Date last updated
15/04/2014

Titles & IDs
Public title
NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions
Scientific 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)
Secondary ID [1] 0 0
NG PROMUS Clinical Trial S2294
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis 0 0
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Percutaneous coronary intervention (NG PROMUS)

Experimental: NG PROMUS stent - Single-arm treatment group receiving interventional NG PROMUS study stent


Treatment: Devices: Percutaneous coronary intervention (NG PROMUS)
Interventional coronary artery stenting with NG PROMUS study stent.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Technical Success Rate
Timepoint [1] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [1] 0 0
Target Lesion Revascularization (TLR) Rate
Timepoint [1] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [2] 0 0
Target Lesion Failure (TLF) Rate
Timepoint [2] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [3] 0 0
Target Vessel Revascularization (TVR) Rate
Timepoint [3] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [4] 0 0
Target Vessel Failure (TVF) Rate
Timepoint [4] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [5] 0 0
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
Timepoint [5] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [6] 0 0
Cardiac Death Rate
Timepoint [6] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [7] 0 0
Non-cardiac Death Rate
Timepoint [7] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [8] 0 0
All Death Rate
Timepoint [8] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [9] 0 0
Cardiac Death or MI Rate
Timepoint [9] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [10] 0 0
All Death or MI Rate
Timepoint [10] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [11] 0 0
All Death/MI/TVR Rate
Timepoint [11] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [12] 0 0
Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
Timepoint [12] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
Secondary outcome [13] 0 0
Clinical Procedural Success Rate
Timepoint [13] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [14] 0 0
In-stent Percent Diameter Stenosis (%DS)
Timepoint [14] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [15] 0 0
In-segment Percent Diameter Stenosis (%DS)
Timepoint [15] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [16] 0 0
In-stent Minimum Lumen Diameter (MLD)
Timepoint [16] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [17] 0 0
In-segment Minimum Lumen Diameter (MLD)
Timepoint [17] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [18] 0 0
Acute Gain
Timepoint [18] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [19] 0 0
Vessel Area
Timepoint [19] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [20] 0 0
Stent Area
Timepoint [20] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [21] 0 0
Lumen Area
Timepoint [21] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [22] 0 0
Vessel Volume
Timepoint [22] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [23] 0 0
Stent Volume
Timepoint [23] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [24] 0 0
Lumen Volume
Timepoint [24] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [25] 0 0
Incomplete Apposition
Timepoint [25] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [26] 0 0
Percent Net Volume Obstruction
Timepoint [26] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [27] 0 0
Longitudinal Stent Deformation
Timepoint [27] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 1 day

Eligibility
Key inclusion criteria
Clinical

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

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

1. Planned treatment of more than 3 lesions.
2. Planned treatment of lesions in more than 2 major epicardial vessels
3. Planned treatment of a single lesion with more than 1 stent
4. Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
5. Target lesion(s) is located in the left main
6. 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.
7. Target lesion(s) is located within a saphenous vein graft or an arterial graft
8. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
9. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
10. Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
11. Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
12. Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
13. 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
14. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Otahuhu
Country [4] 0 0
Singapore
State/province [4] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John A Ormiston, MBChB, FRACP, FRACR
Address 0 0
Mercy Angiography Unit, Ltd. Mercy Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01703000