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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PROMUS Element Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique

Participant Flow:   Overall Study
    PROMUS Element
STARTED   22 
COMPLETED   22 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PROMUS Element Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique

Baseline Measures
   PROMUS Element 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      13  59.1% 
>=65 years      9  40.9% 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.6  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  18.2% 
Male      18  81.8% 
Region of Enrollment 
[Units: Participants]
 
United States   11 
Japan   11 
Cardiac History [1] 
[Units: 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] 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] 
[Units: Percent (of blood emptied)]
Mean (Standard Deviation)
 59.64  (10.09) 
[1] 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 
[Units: Centimeters]
Mean (Standard Deviation)
 165.57  (12.55) 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 73.68  (19.60) 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26.52  (4.79) 
Cardiac Risk Factors [1] 
[Units: Participants]
 
Smoking, ever   14 
Medically Treated Diabetes   5 
Hyperlipidemia Requiring Medication   16 
Hypertension Requiring Medication   18 
[1] 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] 
[Units: Participants]
 
History of Transient Ischemic Attack   2 
History of Cerebrovascular Accident   3 
History of Peripheral Vascular Disease   2 
History of Renal Disease   0 
[1] 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] 
[Units: Lesions]
 
Left Anterior Descending Artery   4 
Left Circumflex Artery   7 
Right Coronary Artery   13 
[1] 24 lesions in 22 participants were treated.
Lesion Characteristic: Lesion Location [1] 
[Units: Participants]
 
Proximal   9 
Mid   13 
Distal   2 
[1] 24 lesions treated in 22 participants.
Lesion Characteristics: Reference Vessel Diameter, Minimum Lumen Diameter, Length [1] 
[Units: Millimeters]
Mean (Standard Deviation)
 
Reference Vessel Diameter   2.64  (0.46) 
Minimum Lumen Diameter   0.73  (0.38) 
Lesion Length   12.11  (4.69) 
[1] There were 24 lesions treated in 22 participants.
Lesion Characteristic-Percent Diameter Stenosis [1] 
[Units: Percent]
Mean (Standard Deviation)
 73.15  (11.24) 
[1] There were 24 lesions treated in 22 participants.
Lesion Characteristics [1] 
[Units: Lesions]
 
Eccentric Lesion   13 
Bend >45 Degrees   13 
Bend >90 Degrees   2 
Tortuosity, any   1 
Calcification, any   4 
Bifurcation   1 
[1] 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] 
[Units: Lesions]
 
 1 
B1   4 
B2   15 
 4 
[1]

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] 
[Units: Lesions]
 
TIMI 0   0 
TIMI 1   0 
TIMI 2   0 
TIMI 3   24 
[1] 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


  Outcome Measures

1.  Primary:   Maximum Observed Everolimus Blood Concentration (Cmax)   [ Time Frame: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours ]

2.  Secondary:   Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus   [ Time Frame: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours ]

3.  Secondary:   Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus   [ Time Frame: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours ]

4.  Secondary:   Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus   [ Time Frame: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours ]

5.  Secondary:   Time of Occurrence of Maximum Everolimus Concentration (Tmax)   [ Time Frame: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours ]

6.  Secondary:   Terminal Phase Half-life (t1/2) Everolimus   [ Time Frame: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours ]

7.  Secondary:   Total Blood Clearance - Everolimus (CL)   [ Time Frame: Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours ]

8.  Secondary:   All Death   [ Time Frame: 6 months ]

9.  Secondary:   Myocardial Infarction (MI) Related to the Target Vessel   [ Time Frame: 6 months ]

10.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 6 months ]

11.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 6 months ]

12.  Secondary:   Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition   [ Time Frame: 24 hours ]

13.  Secondary:   Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition   [ Time Frame: >24 hours-30 days ]

14.  Secondary:   Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition   [ Time Frame: >30 days-1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ruth Starzyk, PhD
Organization: Boston Scientific
phone: 508-683-6577
e-mail: ruth.starzyk@bsci.com



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