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

A Boston Scientific Trial of the EPIC™ Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries

The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.

Study Overview

• Status: Completed
• Conditions: Iliac Artery Stenosis
• Intervention / Treatment: Device: Epic™ Nitinol Stent System; Drug: Anti-platelet therapy; Drug: Anti-coagulation therapy

Detailed Description

ORION is a prospective, single arm, non-randomized, multicenter study. A subject could receive a maximum of 2 study stents for up to 2 target lesions. A maximum of 1 non-target lesion in 1 non-target vessel could be treated with a commercially approved treatment during the index procedure.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • St. Joseph's Hospital
  • Florida
    • Brandon, Florida, United States, 33511
      • Brandon Regional Hospital
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital
    • Ocala, Florida, United States, 34471
      • MediQuest Research at Munroe Regional Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
    • Marietta, Georgia, United States, 46805
      • Wellstar Kennestone Hospital
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Parkview Hospital-Parkview Research Center
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent's Hospital
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Trinity Terrace Park
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Mid-Carolina Cardiology - Presbyterian Hospital
    • Raleigh, North Carolina, United States, 27610
      • Wake Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • Meritcare Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Science Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC - Shadyside Hospital
    • York, Pennsylvania, United States, 17405
      • York Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
    • Nashville, Tennessee, United States, 37205
      • St. Thomas Research Institute
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Health Care System
    • San Antonio, Texas, United States, 78205
      • Baptist Hospital of San Antonio
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Documented chronic, symptomatic iliac artery atherosclerotic disease (Rutherford/Becker category 1, 2, 3 or 4)
• Lifestyle-limiting claudication or rest pain
• De novo or restenotic lesions in the common and/or external iliac artery
• Subjects with bilateral disease may have only one target lesion treated per side
• Two target lesions may be treated with a maximum of two stents (if two target lesions are treated, each lesion must be covered with a maximum of one stent)
• Length of diseased segment(s) <=13 cm and treatment is planned with no more than 2 overlapped Epic™ stents
• Baseline diameter stenosis >= 50% (operator visual assessment)
• Reference vessel diameter >= 5 mm and <=11 mm
• At least one sufficient ipsilateral infrapopliteal run-off vessel
• Origin of profunda femoris artery is patent

Exclusion Criteria:

• Target vessel with in-stent restenosis
• Acute critical limb ischemia
• Tissue loss (Rutherford/Becker category 5 or 6)
• Any major amputations to the target limb
• Any minor amputation of the target limb in the last 12 months. If a minor amputation occurred greater than 12 months, stump needs to be completely healed.
• Life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
• Intolerance to antiplatelet, anticoagulant, or thrombolytic medications
• Platelet count < 150,000 mm3 or > 600,000 mm3
• Serum creatinine > 2.0 mg/dL
• Dialysis-dependent end stage renal disease
• Pregnancy
• Current participation in another drug or device trial that has not completed the primary endpoint or that may potentially confound the results of this trial
• Known allergy to Nitinol
• Presence of arterial lesions (with the exception of renal, carotid or short, focal SFA lesions) requiring intervention within 30 days of the index procedure - Superficial femoral artery occlusion in the limb supplied by target vessel
• Heavily calcified and/or excessively tortuous lesions in the target vessel as determined by angiography
• Target lesion is within or near an aneurysm
• Persistent, intraluminal thrombus of the proposed target lesion post-thrombolytic therapy
• Perforated vessel as evidenced by extravasation of contrast media
• Vascular graft, aneurysm or postsurgical stenosis of the target vessel
• Multiple lesions in the same target vessel unable to be treated with a maximum of two stents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Device: Epic™ Nitinol Stent System; The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.; Drug: Anti-platelet therapy; Investigators must prescribe concomitant anti-platelet medication consistent with current clinical practice. Anti-platelet therapy should be administered preprocedure and continued throughout participation in the trial.; Drug: Anti-coagulation therapy; Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device- and/or Procedure-related Major Adverse Events (MAE)	MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months	9 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death is classified as follows. Cardiac death: death due to immediate cardiac cause, death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions	30 Days
Death	Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions	9 Months
Death	Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions	1 Year
Death	Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions	2 Years
Death	Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions	3 Years
Amputation of Index Limb	Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes	9 Months
Amputation of Index Limb	Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes	1 Year
Amputation of Index Limb	Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes	2 Years
Amputation of Index Limb	Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes	3 Years
Target Vessel Revascularization (TVR)	Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.	30 Days
Target Vessel Revascularization (TVR)	Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.	9 Months
Target Vessel Revascularization (TVR)	Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.	1 Year
Target Vessel Revascularization (TVR)	Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.	2 Years
Target Vessel Revascularization (TVR)	Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.	3 Years
Myocardial Infarction (MI)	Definition of myocardial infarction: New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB)/troponin above upper limit of normal (ULN); if no new Q-waves elevation of post-procedure CK levels >2.0× ULN with positive CK-MB, or, if the assay for CK-MB was not performed, elevation of CK levels >2.0× ULN with positive troponin. Drawing a CK-MB or troponin is mandated if CK is greater than 2× ULN. If no CK-MB or troponin was drawn, CK >2× ULN will be considered an MI. ULN is determined per local laboratory specifications.	Index hospitalization
Technical Success	Residual lesion stenosis <=30% based on visual assessment immediately postprocedure	Index procedure
Procedure Success	Technical success (residual lesion stenosis <=30% based on visual assessment immediately postprocedure) and no in-hospital major adverse events (device- or index procedure-related death, myocardial infarction, target vessel revascularization or amputation of the index limb).	In hospital (1-2 days post procedure)
Early Clinical Success	Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	Hospital Discharge
Early Clinical Success	Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	30 Days
Late Clinical Success	Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	9 Months
Late Clinical Success	Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	1 Year
Early Hemodynamic Success	Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.	Hospital Discharge
Early Hemodynamic Success	Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.	30 Days
Late Hemodynamic Success	Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.	9 Months
Late Hemodynamic Success	Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.	1 Year
Rutherford Classification Distribution	Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic; = Mild claudication; = Moderate claudication; = Severe claudication; = Ischemic rest pain; = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	Pre-procedure/baseline
Rutherford Classification Distribution	Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic; = Mild claudication; = Moderate claudication; = Severe claudication; = Ischemic rest pain; = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	Post-procedure
Rutherford Classification Distribution	Rutherford Classification is used to assess lower extremity ischemia as shown below: 0 = Asymptomatic; = Mild claudication; = Moderate claudication; = Severe claudication; = Ischemic rest pain; = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema	30 Days
Rutherford Classification Distribution	Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss	9 Months
Rutherford Classification Distribution	Rutherford Classification is used to assess lower extremity ischemia as shown below: Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss	1 Year
Acute Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Acute stent thrombosis is defined as occurring <=24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to <=30 days following the trial procedure.	24 Hours
Sub-acute Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Acute stent thrombosis is defined as occurring less than or equal to 24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to less than or equal to 30 days following the trial procedure.	>24 Hours to <=30 Days Post-index procedure
Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Late stent thrombosis is defined as >30 days to 365 days following the trial procedure.	9 Months
Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Late stent thrombosis is defined as >30 days to 365 days following the trial procedure.	1 Year
Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Very late stent thrombosis is defined as >365 days following the trial procedure.	2 Years
Stent Thrombosis	Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion Very late stent thrombosis is defined as >365 days following the trial procedure.	3 Years
Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.	30 Days
Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.	9 Months
Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.	1 Year
Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.	2 Years
Target Lesion Revascularization (TLR)	Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.	3 Years
Ankle-Brachial Index (ABI)	Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.	Pre-procedure/baseline
Ankle-Brachial Index	Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.	Hospital Discharge (1-2 days post-procedure)
Ankle-Brachial Index (ABI)	Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.	30 Days
Ankle-Brachial Index (ABI)	Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.	9 Months
Ankle-Brachial Index (ABI)	Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows: Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation. Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.	1 Year
Primary Patency	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.	9 Months
Primary Patency	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.	1 Year
Primary-assisted Patency (PAP)	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.	9 Months
Primary-assisted Patency (PAP)	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.	1 Year
Secondary Patency	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.	9 Months
Secondary Patency	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.	1 Year
Restenosis Assessed by Duplex Ultrasound	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.	9 Months
Restenosis Assessed by Duplex Ultrasound	Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.	1 Year
Walking Impairment Questionnaire Score - Distance	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	Pre-procedure/baseline
Walking Impairment Questionnaire Score - Distance	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	9 Months
Walking Impairment Questionnaire Score - Distance	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	1 Year
Walking Impairment Questionnaire Score - Speed	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	Pre-procedure/baseline
Walking Impairment Questionnaire Score - Speed	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	9 Months
Walking Impairment Questionnaire Score - Speed	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	1 Year
Walking Impairment Questionnaire Score-Stair Climbing	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	Pre-procedure/baseline
Walking Impairment Questionnaire Score - Stair Climbing	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	9 Months
Walking Impairment Questionnaire Score - Stair Climbing	The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	1 Year

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Pamela G. Grady, Ph.D., Boston Scientific Corporation

Publications and helpful links

General Publications

• Clair DG, Adams J, Reen B, Feldman R, Starr J, Diaz-Cartelle J, Dawkins KD. The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial. J Endovasc Ther. 2014 Apr;21(2):213-22. doi: 10.1583/13-4560.1.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: May 8, 2009
• First Submitted That Met QC Criteria: May 8, 2009
• First Posted (ESTIMATE): May 11, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 7, 2015
• Last Update Submitted That Met QC Criteria: April 17, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: claudication; peripheral vascular disease; iliac artery stenosis; atherosclerotic iliac disease
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: S2020