PROMUS Element Japan Small Vessel Trial

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT01080261

First received: March 2, 2010

Last updated: August 17, 2012

Last verified: August 2012

History of Changes

Results First Received: March 19, 2012

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

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 60 patients was planned and 60 patients were enrolled at 14 sites in Japan from February 8, 2010 to June 15, 2010.

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	Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)

Participant Flow: Overall Study

	PROMUS Element
STARTED	60
COMPLETED	60
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
PROMUS Element	Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)

Baseline Measures

	PROMUS Element
Number of Participants [units: participants]	60
Age [units: participants]
<=18 years	0
Between 18 and 65 years	16
>=65 years	44
Age [units: years] Mean ± Standard Deviation	69.20 ± 9.84
Gender [units: participants]
Female	19
Male	41
Region of Enrollment [units: participants]
Japan	60
Comorbidities ^[1] [units: participant]
History of Peripheral Vascular Disease	5
History of Transient Ischemic Attack	1
History of Cerebrovascular Accident	11
History of Renal Disease	10
History of Gastrointestinal Bleeding	0
Cardiac History ^[2] [units: participants]
Previous Percutaneous Coronary Intervention (PCI)	40
Previous Coronary Artery Bypass Graft (CABG)	1
Previous Myocardial Infarction (MI)	16
Congestive Heart Failure	6
Stable Angina	43
Unstable Angina	8
Silent Ischemia	12
Cardiac History: Left Ventricular Ejection Fraction ^[3] [units: percent] Mean ± Standard Deviation	63.27 ± 10.35
Cardiac Risk Factors ^[2] [units: participants]
Smoking, Ever	37
Medically Treated Diabetes	22
Hyperlipidemia Requiring Medication	46
Hypertension Requiring Medication	51
Family History of Coronary Artery Disease	13
Lesion Characteristic: Target Lesion Vessel [units: Lesions]
Left Anterior Descending Artery	24
Left Circumflex Artery	20
Right Coronary Artery	16
Lesion Characteristic: Lesion Location [units: lesions]
Ostial	11
Proximal	23
Mid	16
Distal	10
Lesion Characteristics [units: millimeter] Mean ± Standard Deviation
Reference Vessel Diameter	2.02 ± 0.26
Minimum Lumen Diameter	0.56 ± 0.25
Lesion Length	12.91 ± 5.91
Lesion Characteristic: Percent Diameter Stenosis ^[4] [units: percent stenosis] Mean ± Standard Deviation	72.52 ± 11.27
Lesion Characteristics ^[5] [units: participants]
Eccentric Lesion	34
> 45 Degree Bend	12
> 90 Degree Bend	0
Tortuosity, any	10
Calcification, any	12
Total Occlusion	1
Bifurcation	4
Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class ^[6] [units: lesions]
Type A	4
Type B1	17
Type B2	27
Type C	12
Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow ^[7] [units: lesions]
TIMI 0	0
TIMI 1	1
TIMI 2	3
TIMI 3	56

[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. Not all participants have one of these comorbidity measures.
[2]	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.
[3]	Left ventricular ejection fraction (LVEF) is an assessment of the amount of blood emptied from the left ventricle during systolic contraction, which is indicative of global ventricular function.
[4]	Extent of stenosis of the target lesion (measured as percent of area stenosed)
[5]	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. Not all participants have one of these lesion characteristics.
[6]	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.
[7]	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:

Major Adverse Cardiac Events (MACE) (Percentage of Participants With an Event) [ Time Frame: 9 months ]

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2. Secondary:

Myocardial Infarction (MI) (Percentage of Participants With an Event) [ Time Frame: 9 months ]

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3. Secondary:

All-cause Death (Percentage of Participants With an Event) [ Time Frame: 9 months ]

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4. Secondary:

Cardiac Death (Percentage of Participants With an Event) [ Time Frame: 9 months ]

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5. Secondary:

Target Vessel Revascularization (Percentage of Participants With an Event) [ Time Frame: 9 months ]

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6. Secondary:

Target Lesion Revascularization (Percentage of Participants With an Event) [ Time Frame: 9 months ]

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7. Secondary:

Target Vessel Failure (TVF) (Percentage of Participants With an Event) [ Time Frame: 9 months ]

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8. Secondary:

Target Lesion Failure (TLF) (Percentage of Participants With an Event) [ Time Frame: 9 months ]

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9. Secondary:

Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event) [ Time Frame: 0-30 Days (Early) ]

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10. Secondary:

Definite + Probable Stent Thrombosis (ST) Based on Academic Research Consortium (ARC) Definition (Percentage of Participants With an Event) [ Time Frame: >30 days - 9 months ]

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11. Secondary:

Technical Success (Percentage of Stents) [ Time Frame: At time of index procedure ]

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12. Secondary:

Clinical Procedural Success (Percentage of Participants) [ Time Frame: While participant is in the hospital ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	9 months
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
PROMUS Element	Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)

Other Adverse Events

	PROMUS Element
Total, other (not including serious) adverse events
# participants affected / at risk	7/60
Infections and infestations
Nasopharyngitis ^{† 1}
# participants affected / at risk	7/60 (11.67%)
# events	7

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDra 12.0

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: In Japan, the study agreement was executed between the head of hospital (not PI) and Boston Scientific Japan. The site must get written approval before they publish any study data/information to an outside community such as a scientific society.

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.

Results Point of Contact:

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

No publications provided

Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT01080261 History of Changes
Other Study ID Numbers:	S2069
Study First Received:	March 2, 2010
Results First Received:	March 19, 2012
Last Updated:	August 17, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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