EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries (ORION)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Boston Scientific Corporation

ClinicalTrials.gov Identifier:

NCT00896337

First received: May 8, 2009

Last updated: July 27, 2012

Last verified: July 2012

History of Changes

Results First Received: April 10, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Iliac Artery Stenosis
Interventions:	Device: Epic™ Nitinol Stent System Drug: Anti-platelet therapy Drug: Anti-coagulation therapy

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 up to 133 subjects was planned; 125 subjects were enrolled at 28 centers in the United States from May 14, 2009 to December 14, 2010.

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
ORION	All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.

Participant Flow: Overall Study

	ORION
STARTED	125
COMPLETED	113
NOT COMPLETED	12
Death	1
Withdrawal by Subject	3
Lost to Follow-up	4
Missed 9-month visit	4

Baseline Characteristics

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Reporting Groups

	Description
ORION	All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.

Baseline Measures

	ORION
Number of Participants [units: participants]	125
Age [units: participants]
<=18 years	0
Between 18 and 65 years	80
>=65 years	45
Age [units: years] Mean ± Standard Deviation	61.1 ± 9.3
Gender [units: participants]
Female	44
Male	81
Race/Ethnicity, Customized [units: participants]
Hispanic or Latino	3
Caucasian	112
Black of African heritage	8
American Indian or Alaska Native	1
Asian	0
Other	1
Region of Enrollment [units: participants]
United States	125
General Medical History ^[1] [units: Participants]
Smoking, Ever	120
Medically Treated Diabetes	42
Hyperlipidemia Requiring Medication	98
Hypertension Requiring Medication	95
History of Chronic Obstructive Pulmonary Disease	31
Cardiac History ^[1] [units: Participants]
History of Coronary Artery Disease	73
History of Myocardial Infarction	35
History of Congestive Heart Failure	10
Stable Angina	15
Unstable Angina	1
Silent Ischemia	0
Previous Percutaneous Coronary Intervention	46
Previous Coronary Artery Bypass Graft	22
Peripheral Vascular History ^[1] [units: Participants]
History of Peripheral Vascular Surgery	10
History of Other Peripheral Endovascular Intervent	25
History of Claudication	116
Neurologic/Renal History ^[1] [units: participants]
History of Transient Ischemic Attack	5
History of Cerebrovascular Accident	7
History of Renal Insufficiency	9
History of Renal Percutaneous Intervention	6
Lesion Characteristic: Target Lesion Vessel ^[2] [units: Lesions]
Left Common Iliac Artery	58
Left External Iliac Artery	16
Right Common Iliac Artery	58
Right External Iliac Artery	28
Lesion Characteristic: Lesion Location ^[2] [units: Lesions]
Ostial	100
Proximal	35
Mid	12
Distal	13
Lesion Characteristics: Size ^[3] [units: millimeters] Mean ± Standard Deviation
Reference Vessel Diameter	7.69 ± 1.79
Minimum Lumen Diameter	2.20 ± 1.34
Lesion Length	31.04 ± 22.13
Lesion Characteristic: Diameter Stenosis ^[2] [units: percent] Mean ± Standard Deviation	71.51 ± 16.27
Lesion Characteristics ^[4] [units: Lesions]
Concentric Lesion	72
Eccentric Lesion	88
> 45 Degree Bend	1
> 90 Degree Bend	0
Thrombus	0
Calcification, Non/Mild	37
Calcification, Moderate	45
Calcification, Severe	78
Ulcerated	29
Total Occlusion	26
Aneurysm	10

[1]	The same participant may be included in more than one category or not all participants may contribute to a category, therefore the number of participants for this baseline measure does not equal the total number of participants in the group.
[2]	These data are reported per lesion. A participant could have more than one lesion, therefore, the number of lesions reported for this baseline measure does not equal the total number of participants in the group.
[3]	These data are reported per lesion.
[4]	These data are reported per lesion. A participant could have more than one lesion; therefore, the number of lesions reported for this baseline measure does not equal the total number of participants in the group. The same participant’s lesion may also be included in more than one category or not all participants may contribute to a category.

Outcome Measures

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1. Primary:

Device- and/or Procedure-related Major Adverse Events (MAE) [ Time Frame: 9 Months ]

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2. Secondary:

Death [ Time Frame: 30 days ]

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3. Secondary:

Death [ Time Frame: 9 Months ]

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4. Secondary:

Amputation of Index Limb [ Time Frame: 9 Months ]

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5. Secondary:

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

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6. Secondary:

Target Vessel Revascularization (TVR) [ Time Frame: 9 Months ]

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7. Secondary:

Myocardial Infarction (MI) [ Time Frame: Index hospitalization ]

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8. Secondary:

Early Clinical Success [ Time Frame: 30 days ]

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9. Secondary:

Late Clinical Success [ Time Frame: 9 Months ]

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10. Secondary:

Rutherford Classification Distribution [ Time Frame: Pre-procedure/baseline ]

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11. Secondary:

Rutherford Classification Distribution [ Time Frame: 9 Months ]

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12. Secondary:

Acute Stent Thrombosis [ Time Frame: 24 hours ]

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13. Secondary:

Sub-acute Stent Thrombosis [ Time Frame: >24 hours to <=30 days post-index procedure ]

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14. Secondary:

Target Lesion Revascularization (TLR) [ Time Frame: 30 Days ]

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15. Secondary:

Target Lesion Revascularization (TLR) [ Time Frame: 9 Months ]

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16. Secondary:

Technical Success [ Time Frame: Index procedure ]

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17. Secondary:

Procedure Success [ Time Frame: In hospital (1-2 days post procedure) ]

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18. Secondary:

Ankle-Brachial Index (ABI) [ Time Frame: Pre-procedure/baseline ]

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19. Secondary:

Ankle-Brachial Index [ Time Frame: Hospital Discharge (1-2 days post-procedure) ]

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20. Secondary:

Ankle-Brachial Index (ABI) [ Time Frame: 9 Months ]

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21. Secondary:

Late Hemodynamic Success [ Time Frame: 9 Months ]

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22. Secondary:

Primary Patency [ Time Frame: 9 months ]

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23. Secondary:

Primary-assisted Patency (PAP) [ Time Frame: 9 months ]

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24. Secondary:

Secondary Patency [ Time Frame: 9 Months ]

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25. Secondary:

Restenosis Assessed by Duplex Ultrasound [ Time Frame: 9 Months ]

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26. Secondary:

Walking Impairment Questionnaire Score - Distance [ Time Frame: Pre-procedure/baseline ]

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27. Secondary:

Walking Impairment Questionnaire Score - Distance [ Time Frame: 9 Months ]

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28. Secondary:

Walking Impairment Questionnaire Score - Speed [ Time Frame: Pre-procedure/baseline ]

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29. Secondary:

Walking Impairment Questionnaire Score - Speed [ Time Frame: 9 Months ]

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30. Secondary:

Walking Impairment Questionnaire Score-Stair Climbing [ Time Frame: Pre-procedure/baseline ]

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31. Secondary:

Walking Impairment Questionnaire Score - Stair Climbing [ Time Frame: 9 Months ]

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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 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.

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 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:	NCT00896337 History of Changes
Other Study ID Numbers:	S2020
Study First Received:	May 8, 2009
Results First Received:	April 10, 2012
Last Updated:	July 27, 2012
Health Authority:	United States: Food and Drug Administration

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