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PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK) (PLATINUM PK)

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ClinicalTrials.gov Identifier: NCT01510327
Recruitment Status : Completed
First Posted : January 16, 2012
Results First Posted : April 5, 2012
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Device: PROMUS Element Everolimus-Eluting Coronary Stent System
Drug: Aspirin
Drug: Thienopyridine
Enrollment 22
Recruitment Details From October 9, 2009 to February 9, 2010 there were 11 patients enrolled at 2 investigative sites in the United States and 11 patients enrolled at 3 sites in Japan. All enrolled patients received a PROMUS Element study stent.
Pre-assignment Details  
Arm/Group Title PROMUS Element
Hide Arm/Group Description Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Period Title: Overall Study
Started 22
Completed 22
Not Completed 0
Arm/Group Title PROMUS Element
Hide Arm/Group Description Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
  59.1%
>=65 years
9
  40.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
64.6  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
4
  18.2%
Male
18
  81.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants
United States 11
Japan 11
Cardiac History   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants
Previous Percutaneous Coronary Intervention (PCI) 9
Previous Coronary Artery Bypass Graft (CABG) 2
Previous Myocardial Infarction (MI) 4
Stable Angina 15
Unstable Angina 2
Silent Ischemia 5
History of Multivessel Disease 9
[1]
Measure Description: The same participant may be included in more than one category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Cardiac History - Left Ventricular Ejection Fraction   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent (of blood emptied)
Number Analyzed 22 participants
59.64  (10.09)
[1]
Measure Description: Left ventricular ejection fraction (LVEF) is an assessment (fraction) of the amount of blood emptied from the left ventricle during systolic contraction, which is indicative of global ventricular function.
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 22 participants
165.57  (12.55)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 22 participants
73.68  (19.60)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 22 participants
26.52  (4.79)
Cardiac Risk Factors   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants
Smoking, ever 14
Medically Treated Diabetes 5
Hyperlipidemia Requiring Medication 16
Hypertension Requiring Medication 18
[1]
Measure Description: The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Comorbidities   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants
History of Transient Ischemic Attack 2
History of Cerebrovascular Accident 3
History of Peripheral Vascular Disease 2
History of Renal Disease 0
[1]
Measure Description: The same participant may be included in more than one category therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
Lesion Characteristic: Target Lesion Vessel   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 22 participants
Left Anterior Descending Artery 4
Left Circumflex Artery 7
Right Coronary Artery 13
[1]
Measure Description: 24 lesions in 22 participants were treated.
Lesion Characteristic: Lesion Location   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants
Proximal 9
Mid 13
Distal 2
[1]
Measure Description: 24 lesions treated in 22 participants.
Lesion Characteristics: Reference Vessel Diameter, Minimum Lumen Diameter, Length   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 22 participants
Reference Vessel Diameter 2.64  (0.46)
Minimum Lumen Diameter 0.73  (0.38)
Lesion Length 12.11  (4.69)
[1]
Measure Description: There were 24 lesions treated in 22 participants.
Lesion Characteristic-Percent Diameter Stenosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 22 participants
73.15  (11.24)
[1]
Measure Description: There were 24 lesions treated in 22 participants.
Lesion Characteristics   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 22 participants
Eccentric Lesion 13
Bend >45 Degrees 13
Bend >90 Degrees 2
Tortuosity, any 1
Calcification, any 4
Bifurcation 1
[1]
Measure Description: There were 24 lesions treated in 22 participants. The same lesion may be included in more than one category, therefore the number of lesions for this baseline measure does not equal the total number of lesions in the group.
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 22 participants
A 1
B1 4
B2 15
C 4
[1]
Measure Description:

Type A: minimally complex, readily accessible, non angulated, smooth contour, little to no calcification, less than totally occlusive, not ostial in location, no major side branch involvement, absence of thrombus.

Type B: moderately complex, eccentric, moderate tortuosity and angulation, moderate or heavy calcification, total occlusion < 3 months old, ostial in location, presence of thrombus; type B1 has one adverse characteristic and B2 has ≥2. Type C: severely complex, diffuse, excessive tortuosity and angulation, total occlusions > 3 months old, degenerated vein grafts and friable lesions.

Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 22 participants
TIMI 0 0
TIMI 1 0
TIMI 2 0
TIMI 3 24
[1]
Measure Description: 24 lesions treated in 22 participants. Thrombolysis In Myocardial Infarction (TIMI)0 - No perfusion; TIMI 1 - Penetration with minimal perfusion; TIMI 2 - Partial perfusion; TIMI 3 - Complete perfusion
1.Primary Outcome
Title Maximum Observed Everolimus Blood Concentration (Cmax)
Hide Description Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent
Time Frame Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis groups reported here had 3 or more subjects.
Arm/Group Title Everolimus Dose of 95.4 µg Everolimus Dose of 102.4 µg Everolimus Dose of 138.6 µg
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
Overall Number of Participants Analyzed 4 7 3
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.71  (0.09) 0.67  (0.15) 0.91  (0.20)
2.Secondary Outcome
Title Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus
Hide Description Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent; t is the last time at which concentration can be quantified
Time Frame Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis groups reported here had 3 or more subjects.
Arm/Group Title Everolimus Dose of 95.4 µg Everolimus Dose of 102.4 µg Everolimus Dose of 138.6 µg
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Overall Number of Participants Analyzed 4 7 3
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
7.27  (4.97) 6.45  (5.26) 10.87  (7.36)
3.Secondary Outcome
Title Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus
Hide Description Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent
Time Frame Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis groups reported here had 3 or more subjects.
Arm/Group Title Everolimus Dose of 95.4 µg Everolimus Dose of 102.4 µg Everolimus Dose of 138.6 µg
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Overall Number of Participants Analyzed 4 7 3
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
6.83  (2.03) 6.14  (1.10) 9.51  (0.64)
4.Secondary Outcome
Title Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus
Hide Description Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after implantation of the last study stent.
Time Frame Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; AUC0-∞ could be inaccurately determined for a subset of samples. AUC0-∞ determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine AUC0-∞.
Arm/Group Title Everolimus Dose of 95.4 µg Everolimus Dose of 102.4 µg Everolimus Dose of 138.6 µg
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Overall Number of Participants Analyzed 4 7 3
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
19.26  (11.69) 12.95  (2.05) 60.74  (25.95)
5.Secondary Outcome
Title Time of Occurrence of Maximum Everolimus Concentration (Tmax)
Hide Description Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent
Time Frame Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis groups reported here had 3 or more subjects.
Arm/Group Title Everolimus Dose of 95.4 µg Everolimus Dose of 102.4 µg Everolimus Dose of 138.6 µg
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Overall Number of Participants Analyzed 4 7 3
Mean (Standard Deviation)
Unit of Measure: hours
0.47  (0.03) 0.62  (0.23) 0.52  (0.09)
6.Secondary Outcome
Title Terminal Phase Half-life (t1/2) Everolimus
Hide Description Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.
Time Frame Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; half-life could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine half-life.
Arm/Group Title Everolimus Dose of 95.4 µg Everolimus Dose of 102.4 µg Everolimus Dose of 138.6 µg
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Overall Number of Participants Analyzed 4 7 3
Mean (Standard Deviation)
Unit of Measure: Hours
34.19  (20.81) 22.83  (7.20) 136.06  (62.08)
7.Secondary Outcome
Title Total Blood Clearance - Everolimus (CL)
Hide Description Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.
Time Frame Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; CL could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine CL value.
Arm/Group Title Everolimus Dose of 95.4 µg Everolimus Dose of 102.4 µg Everolimus Dose of 138.6 µg
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
Overall Number of Participants Analyzed 4 7 3
Mean (Standard Deviation)
Unit of Measure: L/h
6445  (3924) 8044  (1276) 2511  (1073)
8.Secondary Outcome
Title All Death
Hide Description Number of participants no longer alive
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of participants who died
0.0
9.Secondary Outcome
Title Myocardial Infarction (MI) Related to the Target Vessel
Hide Description New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase (CK) MB or troponin >normal; if no new Q-waves total CK levels >3× normal (peri-percutaneous coronary intervention [PCI]) or >2× normal (spontaneous) with elevated CK-MB or troponin >3× normal (peri-PCI) or >2× normal (spontaneous) plus at least one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× normal
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of participants
0.0
10.Secondary Outcome
Title Target Vessel Revascularization (TVR)
Hide Description TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of participants
0.0
11.Secondary Outcome
Title Target Lesion Revascularization (TLR)
Hide Description TLR 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of participants
0.0
12.Secondary Outcome
Title Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
Hide Description DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of participants
0.0
13.Secondary Outcome
Title Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition
Hide Description DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Time Frame >24 hours-30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of participants
0.0
14.Secondary Outcome
Title Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition
Hide Description DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Time Frame >30 days-1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of participants
0.0
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PROMUS Element
Hide Arm/Group Description Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
All-Cause Mortality
PROMUS Element
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PROMUS Element
Affected / at Risk (%) # Events
Total   2/22 (9.09%)    
Gastrointestinal disorders   
Gastritis erosive  1  1/22 (4.55%)  1
Injury, poisoning and procedural complications   
Vascular pseudoaneurysm  1  1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders   
Synovial cyst  1  1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/22 (4.55%)  1
Vascular disorders   
Deep vein thrombosis  1  1/22 (4.55%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PROMUS Element
Affected / at Risk (%) # Events
Total   9/22 (40.91%)    
Cardiac disorders   
Angina pectoris  1  3/22 (13.64%)  3
General disorders   
Catheter site haematoma  1  4/22 (18.18%)  4
Non-cardiac chest pain  1  2/22 (9.09%)  2
Musculoskeletal and connective tissue disorders   
Back pain  1  2/22 (9.09%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Principal Investigator shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to Sponsor for review at least 45 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
Results Point of Contact
Name/Title: Ruth Starzyk, PhD
Organization: Boston Scientific
Phone: 508-683-6577
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01510327     History of Changes
Other Study ID Numbers: S2046B
First Submitted: December 21, 2011
First Posted: January 16, 2012
Results First Submitted: January 16, 2012
Results First Posted: April 5, 2012
Last Update Posted: March 13, 2017