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: January 10, 2014
Last verified: January 2014
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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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  
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 ]

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

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

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

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

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

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

8.  Secondary:   Early Clinical Success   [ Time Frame: 30 days ]

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

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

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

12.  Secondary:   Acute Stent Thrombosis   [ Time Frame: 24 hours ]

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

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

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

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

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

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

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

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

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

22.  Secondary:   Primary Patency   [ Time Frame: 9 months ]

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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.


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, 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: January 10, 2014
Health Authority: United States: Food and Drug Administration