The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels (PLATINUM SV)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT01498692

First received: December 20, 2011

Last updated: March 19, 2012

Last verified: March 2012

History of Changes

Results First Received: January 10, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Coronary Artery Disease
Intervention:	Device: PROMUS Element Coronary Stent System

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment of 94 patients was planned and 94 patients were enrolled at 23 sites in Australia, Belgium, France, Japan, New Zealand, and the United States from February 9, 2009 to December 10, 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
PROMUS Element	Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent

Participant Flow: Overall Study

	PROMUS Element
STARTED	94
COMPLETED	86
NOT COMPLETED	8
Death	4
Withdrawal by Subject	1
Missed 12-month visit	3

Baseline Characteristics

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Reporting Groups

	Description
PROMUS Element	Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent

Baseline Measures

	PROMUS Element
Number of Participants [units: participants]	94
Age [units: participants]
<=18 years	0
Between 18 and 65 years	43
>=65 years	51
Age [units: years] Mean ± Standard Deviation	64.33 ± 11.03
Gender [units: participants]
Female	26
Male	68
Race/Ethnicity, Customized ^[1] [units: Participant]
Hispanic or Latino	7
Caucasian	80
Asian	4
Black of African heritage	4
Region of Enrollment [units: participants]
France	6
United States	75
Belgium	5
Australia	4
Japan	3
New Zealand	1
Cardiac History ^[1] [units: Participant]
Previous Percutaneous Coronary Intervention (PCI)	41
Previous Coronary Artery Bypass Graft (CABG)	13
Previous Myocardial Infarction (MI)	28
Congestive Heart Failure	9
Stable Angina	50
Unstable Angina	23
Silent Ischemia	21
Cardiac History: Ejection Fraction [units: ejection fraction percent] Mean ± Standard Deviation	58.07 ± 10.00
Cardiac Risk Factors ^[1] [units: participants]
Smoking, Ever	59
Medically Treated Diabetes	40
Hyperlipidemia Requiring Medication	77
Hypertension Requiring Medication	75
Family History of Coronary Artery Disease	57
Comorbidities ^[1] [units: participants]
History of Peripheral Vascular Disease	13
History of Transient Ischemic Attack	5
History of Cerebrovascular Accident	3
History of Renal Disease	2
History of Gastrointestinal Bleeding	1
Lesion Characteristic: Target Lesion Vessel [units: lesions]
Left Anterior Descending Artery	32
Left Circumflex Artery	41
Right Coronary Artery	21
Lesion Characteristic: Lesion Location [units: Lesions]
Ostial	2
Proximal	40
Mid	37
Distal	15
Lesion Characteristics [units: millimeters] Mean ± Standard Deviation
Reference Vessel Diameter	2.04 ± 0.26
Minimum Lumen Diameter	0.51 ± 0.21
Lesion Length	14.15 ± 7.03
Lesion Characteristic: Percent Diameter Stenosis [units: percent] Mean ± Standard Deviation	75.10 ± 9.50
Lesion Characteristics ^[1] [units: lesions]
Eccentric Lesion	66
> 45 Degree Bend	21
> 90 Degree Bend	3
Tortuosity, any	5
Calcification, any	23
Total Occlusion	0
Bifurcation	6
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class ^[2] [units: lesions]
Type A	8
Type B1	21
Type B2	41
Type C	24
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow ^[3] [units: participants]
TIMI 0	0
TIMI 1	0
TIMI 2	6
TIMI 3	88

[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.
[2]	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.
[3]	TIMI 0 - No perfusion; TIMI 1 - Penetration with minimal perfusion; TIMI 2 - Partial perfusion; TIMI 3 - Complete perfusion

[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.

[2]

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.

[3]

TIMI 0 - No perfusion; TIMI 1 - Penetration with minimal perfusion; TIMI 2 - Partial perfusion; TIMI 3 - Complete perfusion

Outcome Measures

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1. Primary:

Target Lesion Failure (TLF) [ Time Frame: 12 Months ]

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2. Secondary:

Target Lesion Failure (TLF) [ Time Frame: 6 Months ]

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3. Secondary:

Target Lesion Failure (TLF) [ Time Frame: 30 Days ]

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4. Secondary:

Target Vessel Failure (TVF) [ Time Frame: 12 Months ]

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5. Secondary:

Target Vessel Failure (TVF) [ Time Frame: 6 Months ]

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6. Secondary:

Target Vessel Failure (TVF) [ Time Frame: 30 Days ]

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7. Secondary:

Myocardial Infarction (MI) Related to the Target Vessel [ Time Frame: 12 Months ]

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8. Secondary:

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

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9. Secondary:

Myocardial Infarction (MI) Related to the Target Vessel [ Time Frame: 30 days ]

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10. Secondary:

All Cause Mortality [ Time Frame: 12 months ]

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11. Secondary:

All Cause Mortality [ Time Frame: 6 months ]

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12. Secondary:

All Cause Mortality [ Time Frame: 30 days ]

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13. Secondary:

Cardiac Death Related to the Target Vessel [ Time Frame: 12 months ]

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14. Secondary:

Cardiac Death Related to the Target Vessel [ Time Frame: 6 months ]

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15. Secondary:

Cardiac Death Related to the Target Vessel [ Time Frame: 30 days ]

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16. Secondary:

Target Lesion Revascularization (TLR) [ Time Frame: 12 months ]

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17. Secondary:

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

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18. Secondary:

Target Lesion Revascularization TLR) [ Time Frame: 30 days ]

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19. Secondary:

Target Vessel Revascularization (TVR) [ Time Frame: 12 months ]

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20. Secondary:

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

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21. Secondary:

Target Vessel Revascularization (TVR) [ Time Frame: 30 days ]

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22. Secondary:

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

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23. Secondary:

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

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24. Secondary:

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

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25. Secondary:

Acute Technical Success [ Time Frame: During the index procedure (minutes) ]

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26. Secondary:

Clinical Procedural Success [ Time Frame: Duration of Hospital Stay (average 1-2 days) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Principal Investigator (PI) shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to the 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.

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
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Results Point of Contact:

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

No publications provided

Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT01498692 History of Changes
Other Study ID Numbers:	S2046A
Study First Received:	December 20, 2011
Results First Received:	January 10, 2012
Last Updated:	March 19, 2012
Health Authority:	United States: Food and Drug Administration Japan: Ministry of Health, Labor and Welfare

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