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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00896337
First received: May 8, 2009
Last updated: April 17, 2015
Last verified: April 2015
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   100 
NOT COMPLETED   25 
Death                7 
Withdrawal by Subject                7 
Lost to Follow-up                11 



  Baseline Characteristics
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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
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 
Overall Participants Analyzed 
[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   121 
Medically Treated Diabetes   42 
Hyperlipidemia Requiring Medication   98 
Hypertension Requiring Medication   95 
History of Chronic Obstructive Pulmonary Disease   31 
[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.
Cardiac History [1] 
[Units: Participants]
 
History of Coronary Artery Disease   73 
History of Myocardial Infarction   36 
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 
[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.
Peripheral Vascular History [1] 
[Units: Participants]
 
History of Peripheral Vascular Surgery   10 
History of Other Peripheral Endovascular Intervent   25 
History of Claudication   116 
[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.
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 
[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.
Lesion Characteristic: Target Lesion Vessel [1] 
[Units: Lesions]
 
Left Common Iliac Artery   58 
Left External Iliac Artery   16 
Right Common Iliac Artery   58 
Right External Iliac Artery   28 
[1] 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.
Lesion Characteristic: Lesion Location [1] 
[Units: Lesions]
 
Ostial   100 
Proximal   35 
Mid   12 
Distal   13 
[1] 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.
Lesion Characteristics: Size [1] 
[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) 
[1] These data are reported per lesion.
Lesion Characteristic: Diameter Stenosis [1] 
[Units: Percent]
Mean (Standard Deviation)
 71.51  (16.27) 
[1] 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.
Lesion Characteristics [1] 
[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] 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 ]

2.  Secondary:   Death   [ Time Frame: 30 Days ]

3.  Secondary:   Death   [ Time Frame: 9 Months ]

4.  Secondary:   Death   [ Time Frame: 1 Year ]

5.  Secondary:   Death   [ Time Frame: 2 Years ]

6.  Secondary:   Death   [ Time Frame: 3 Years ]

7.  Secondary:   Amputation of Index Limb   [ Time Frame: 9 Months ]

8.  Secondary:   Amputation of Index Limb   [ Time Frame: 1 Year ]

9.  Secondary:   Amputation of Index Limb   [ Time Frame: 2 Years ]

10.  Secondary:   Amputation of Index Limb   [ Time Frame: 3 Years ]

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

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

13.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 1 Year ]

14.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 2 Years ]

15.  Secondary:   Target Vessel Revascularization (TVR)   [ Time Frame: 3 Years ]

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

17.  Secondary:   Technical Success   [ Time Frame: Index procedure ]

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

19.  Secondary:   Early Clinical Success   [ Time Frame: Hospital Discharge ]

20.  Secondary:   Early Clinical Success   [ Time Frame: 30 Days ]

21.  Secondary:   Late Clinical Success   [ Time Frame: 9 Months ]

22.  Secondary:   Late Clinical Success   [ Time Frame: 1 Year ]

23.  Secondary:   Early Hemodynamic Success   [ Time Frame: Hospital Discharge ]

24.  Secondary:   Early Hemodynamic Success   [ Time Frame: 30 Days ]

25.  Secondary:   Late Hemodynamic Success   [ Time Frame: 9 Months ]

26.  Secondary:   Late Hemodynamic Success   [ Time Frame: 1 Year ]

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

28.  Secondary:   Rutherford Classification Distribution   [ Time Frame: Post-procedure ]

29.  Secondary:   Rutherford Classification Distribution   [ Time Frame: 30 Days ]

30.  Secondary:   Rutherford Classification Distribution   [ Time Frame: 9 Months ]

31.  Secondary:   Rutherford Classification Distribution   [ Time Frame: 1 Year ]

32.  Secondary:   Acute Stent Thrombosis   [ Time Frame: 24 Hours ]

33.  Secondary:   Sub-acute Stent Thrombosis   [ Time Frame: >24 Hours to <=30 Days Post-index procedure ]

34.  Secondary:   Stent Thrombosis   [ Time Frame: 9 Months ]

35.  Secondary:   Stent Thrombosis   [ Time Frame: 1 Year ]

36.  Secondary:   Stent Thrombosis   [ Time Frame: 2 Years ]

37.  Secondary:   Stent Thrombosis   [ Time Frame: 3 Years ]

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

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

40.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 1 Year ]

41.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 2 Years ]

42.  Secondary:   Target Lesion Revascularization (TLR)   [ Time Frame: 3 Years ]

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

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

45.  Secondary:   Ankle-Brachial Index (ABI)   [ Time Frame: 30 Days ]

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

47.  Secondary:   Ankle-Brachial Index (ABI)   [ Time Frame: 1 Year ]

48.  Secondary:   Primary Patency   [ Time Frame: 9 Months ]

49.  Secondary:   Primary Patency   [ Time Frame: 1 Year ]

50.  Secondary:   Primary-assisted Patency (PAP)   [ Time Frame: 9 Months ]

51.  Secondary:   Primary-assisted Patency (PAP)   [ Time Frame: 1 Year ]

52.  Secondary:   Secondary Patency   [ Time Frame: 9 Months ]

53.  Secondary:   Secondary Patency   [ Time Frame: 1 Year ]

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

55.  Secondary:   Restenosis Assessed by Duplex Ultrasound   [ Time Frame: 1 Year ]

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

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

58.  Secondary:   Walking Impairment Questionnaire Score - Distance   [ Time Frame: 1 Year ]

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

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

61.  Secondary:   Walking Impairment Questionnaire Score - Speed   [ Time Frame: 1 Year ]

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

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

64.  Secondary:   Walking Impairment Questionnaire Score - Stair Climbing   [ Time Frame: 1 Year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
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: Angela Schutt
Organization: Boston Scientific
phone: 763-494-2166
e-mail: schutta@bsci.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: April 17, 2015
Health Authority: United States: Food and Drug Administration