Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Prospective, Multi-center Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) (PLATINUM QCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00824434
Recruitment Status : Completed
First Posted : January 16, 2009
Results First Posted : March 7, 2012
Last Update Posted : August 30, 2012
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
Conditions Atherosclerosis
Coronary Artery Disease
Intervention Device: PROMUS Element™
Enrollment 100
Recruitment Details Enrollment of 100 subjects was planned, 100 were enrolled at 14 investigative sites in the Asia Pacific region by July 22, 2009.
Pre-assignment Details  
Arm/Group Title PROMUS Element
Hide Arm/Group Description Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Period Title: Overall Study
Started 100
Completed 100
Not Completed 0
Arm/Group Title PROMUS Element
Hide Arm/Group Description Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
<=18 years
0
   0.0%
Between 18 and 65 years
60
  60.0%
>=65 years
40
  40.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
61.82  (9.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
23
  23.0%
Male
77
  77.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 100 participants
Asian 16
Caucasian 78
Maori 1
Native Hawaiian or other Pacific Islander 2
Other 3
[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.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants
Malaysia 9
Singapore 3
Australia 49
New Zealand 39
General Medical History   [1] 
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 100 participants
Smoking, Ever 64
Medically Treated Diabetes 19
Hyperlipidemia Requiring Medication 81
Hypertension Requiring. Medication 66
History of Bleeding Disorder 3
[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   [1] 
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 100 participants
Stable Angina 57
Unstable Angina 38
No Angina 5
Silent Ischemia 2
Family History of Coronary Artery Disease 49
Previous MI 39
History of Percutaneous Coronary Intervention 31
History of Coronary Artery Bypass Graft 5
History of Arrhythmia 4
History of Multivessel Disease 34
History of Left Main Disease 2
[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  
Mean (Standard Deviation)
Unit of measure:  Percent ejection fraction
Number Analyzed 100 participants
64.41  (13.30)
Neurologic History   [1] 
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 100 participants
History of Transient Ischemic Attack 2
History of Cerebrovascular Accident 3
[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.
Renal and Peripheral History   [1] 
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 100 participants
History of Renal Disease 1
History of Peripheral Vascular Disease 3
[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 Vessel  
Measure Type: Number
Unit of measure:  Lesion
Number Analyzed 100 participants
Left Anterior Descending Artery 35
Left Circumflex Artery 30
Right Coronary Artery 35
Lesion Location  
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 100 participants
Proximal 37
Mid 54
Distal 7
Ostial 2
Lesion Characteristics  
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 100 participants
Reference Vessel Diameter 2.72  (0.53)
Minimum Lumen Diameter 0.71  (0.34)
Lesion Length 15.40  (7.03)
Lesion Characteristic-Diameter Stenosis  
Mean (Standard Deviation)
Unit of measure:  Percent Diameter Stenosis
Number Analyzed 100 participants
74.09  (10.93)
Lesion Characteristics   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 100 participants
Eccentric Lesion 53
Bend >45% 12
Tortuosity 9
Calcification, any 18
Total Occlusion 1
Branch Vessel Disease 6
[1]
Measure Description: 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 or participants 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 100 participants
A 5
B1 28
B2 42
C 25
[1]
Measure Description:

Type A lesions: 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, and an absence of thrombus.

Type B lesions: moderately complex, eccentric, moderate tortuosity and angulation, moderate or heavy calcification, total occlusion < 3 months old, ostial in location, with presence of thrombus.

Type C lesions: severely complex, diffuse, excessive tortuosity and angulation, total occlusions > 3 months old, degenerated vein grafts and friable lesions.

Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow   [1] 
Measure Type: Number
Unit of measure:  Lesion
Number Analyzed 100 participants
0 1
1 0
2 1
3 98
[1]
Measure Description: TIMI 0 - No perfusion TIMI 1 - Penetration with minimal perfusion TIMI 2 - Partial perfusion TIMI 3 - Complete perfusion
1.Primary Outcome
Title Cardiac Events (Composite)
Hide Description Percentage of patients who had a myocardial infarction, cardiac death, target lesion revascularization, or stent thrombosis (defined as definite or probable per the Academic Research Consortium [ARC] definitions); see below for definitions of individual components.
Time Frame 30 days
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
1.0
2.Secondary Outcome
Title In-stent Late Loss
Hide Description In-stent late loss by quantitative coronary angiography in workhorse target lesions (visual reference vessel diameter [RVD] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm)
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat; all patients in the study with workhorse lesions (visual reference vessel diameter [RVD] ≥2.5 mm and ≤4.25 mm and visual lesion length ≤24 mm) underwent clinical follow up to provide the information needed for this endpoint.
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 73
Mean (Standard Deviation)
Unit of Measure: millimeters
0.17  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROMUS Element
Comments The Student t-test was used to compare the outcome to a prespecified performance goal of 0.44 mm based on an historical TAXUS Express workhorse 9-month in-stent late loss (0.41 mm) value plus delta (0.03 mm)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean In-stent Late Loss in WH Lesions
Estimated Value 0.17
Confidence Interval (1-Sided) 95%
0.22
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Occurance of Post-procedure Incomplete Stent Apposition
Hide Description Percentage of participants who experience incomplete stent apposition as determined immediately post-procedure by intravascular ultrasound
Time Frame Post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device) and who underwent intravascular ultrasound to determine extent of stent apposition
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: percentage of participants
5.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PROMUS Element
Comments A one-sided 95% Clopper-Pearson upper confidence bound was derived and tested to determine if the outcome was less than a prespecified performance goal based on historical XIENCE V/PROMUS post-procedure incomplete apposition data from the SPIRIT III study (34.4%).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sided exact binomial test
Comments [Not Specified]
Method of Estimation Estimation Parameter Percent Post-procedure Incomplete Apposi
Estimated Value 5.7
Confidence Interval (1-Sided) 95%
11.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Myocardial Infarction (MI)
Hide Description New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥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, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN
Time Frame 12 months
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
0.0
5.Secondary Outcome
Title All-cause Mortality
Hide Description [Not Specified]
Time Frame 12 months
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
0.0
6.Secondary Outcome
Title Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (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 30 Days
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
1.0
7.Secondary Outcome
Title Target Lesion Revascularization (TLR)
Hide Description Target lesion revascularization (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 12 Months
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
1.0
8.Secondary Outcome
Title Target Vessel Revascularization (TVR)
Hide Description Target vessel revascularization (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 30 Days
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
1.0
9.Secondary Outcome
Title Target Vessel Revascularization (TVR)
Hide Description Target vessel revascularization (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 12 months
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
1.0
10.Secondary Outcome
Title Target Lesion Failure (TLF)
Hide Description Target lesion failure (TLF) is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non–Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Time Frame 12 months
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
1.0
11.Secondary Outcome
Title Target Vessel Failure (TVF)
Hide Description Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (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.
Time Frame 12 months
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
1.0
12.Secondary Outcome
Title Definite + Probable Stent Thrombosis 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
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
1.0
13.Secondary Outcome
Title Definite + Probable Stent Thrombosis 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 hr-30 days
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
0.0
14.Secondary Outcome
Title Definite + Probable Stent Thrombosis 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
Hide 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:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
0.0
15.Secondary Outcome
Title Clinical Procedural Success
Hide Description Mean lesion diameter stenosis < 30% with TIMI 3 flow without the occurrence of in-hospital cardiac death, MI, or TVR
Time Frame Duration of hospital stay (usually 1-2 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
99.0
16.Secondary Outcome
Title Technical Success
Hide Description Successful delivery and deployment of the study stent to the target lesion, without balloon rupture or embolization, summarized per stent.
Time Frame Acute-At time of index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title PROMUS Element
Hide Arm/Group Description:
Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
Overall Number of Participants Analyzed 100
Overall Number of Units Analyzed
Type of Units Analyzed: Stents attempted in the target vessel
108
Measure Type: Number
Unit of Measure: percentage of stents attempted
100.0
Time Frame Site reported adverse events were collected through 365 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PROMUS Element
Hide Arm/Group Description Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
All-Cause Mortality
PROMUS Element
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PROMUS Element
Affected / at Risk (%) # Events
Total   27/100 (27.00%)    
Cardiac disorders   
Angina pectoris  1  4/100 (4.00%)  5
Angina unstable  1  3/100 (3.00%)  5
Coronary artery dissection  1  3/100 (3.00%)  4
Myocardial infarction  1  2/100 (2.00%)  2
Arteriospasm coronary  1  1/100 (1.00%)  1
Coronary artery disease  1  1/100 (1.00%)  1
Coronary artery stenosis  1  1/100 (1.00%)  1
Coronary artery thrombosis  1  1/100 (1.00%)  1
Eye disorders   
Blindness unilateral  1  1/100 (1.00%)  1
Macular hole  1  1/100 (1.00%)  1
General disorders   
Non-cardiac chest pain  1  8/100 (8.00%)  8
Catheter site discharge  1  1/100 (1.00%)  1
Catheter site haemorrhage  1  1/100 (1.00%)  1
Chest pain  1  1/100 (1.00%)  1
Infections and infestations   
Appendicitis  1  1/100 (1.00%)  1
Diverticulitis  1  1/100 (1.00%)  1
Gastroenteritis viral  1  1/100 (1.00%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain  1  3/100 (3.00%)  3
Back pain  1  1/100 (1.00%)  1
Musculoskeletal pain  1  1/100 (1.00%)  1
Osteoarthritis  1  1/100 (1.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder transitional cell carcinoma  1  1/100 (1.00%)  1
Meningioma  1  1/100 (1.00%)  1
Neuroendocrine carcinoma  1  1/100 (1.00%)  1
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema  1  1/100 (1.00%)  1
Dyspnoea  1  1/100 (1.00%)  1
Vascular disorders   
Intermittant claudication  1  2/100 (2.00%)  2
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   48/100 (48.00%)    
Cardiac disorders   
Angina pectoris  1  7/100 (7.00%)  7
Coronary artery dissection  1  8/100 (8.00%)  8
Myocardial infarction  1  8/100 (8.00%)  8
General disorders   
Non-cardiac chest pain  1  8/100 (8.00%)  9
Catheter site haematoma  1  7/100 (7.00%)  8
Adverse drug reaction  1  6/100 (6.00%)  7
Catheter site discharge  1  6/100 (6.00%)  7
Chest pain  1  5/100 (5.00%)  5
Investigations   
Troponin increased  1  12/100 (12.00%)  12
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 40 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
Layout table for Results Point of Contact information
Name/Title: Ruth Starzyk, PhD
Organization: Boston Scientific
Phone: 508-683-6577
EMail: ruth.starzyk@bsci.com
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00824434     History of Changes
Other Study ID Numbers: S2051
First Submitted: January 15, 2009
First Posted: January 16, 2009
Results First Submitted: December 20, 2011
Results First Posted: March 7, 2012
Last Update Posted: August 30, 2012