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NCT Number: NCT00896337

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.

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Key information

Conditions

Iliac Artery Stenosis Cardiovascular Diseases Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Joseph's Hospital, Tucson, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epic™ Nitinol Stent System

Device

The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.

Anti-platelet therapy

Drug

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.

Anti-coagulation therapy

Drug

Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.

Primary outcomes

  1. Device- and/or Procedure-related Major Adverse Events (MAE)

    Time frame: 9 Months

    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

Secondary outcomes

  1. Death

    Time frame: 30 Days

    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. Death

    Time frame: 9 Months

    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. Death

    Time frame: 1 Year

    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

  4. Death

    Time frame: 2 Years

    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

  5. Death

    Time frame: 3 Years

    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

  6. Amputation of Index Limb

    Time frame: 9 Months

    Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes

  7. Amputation of Index Limb

    Time frame: 1 Year

    Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes

  8. Amputation of Index Limb

    Time frame: 2 Years

    Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes

  9. Amputation of Index Limb

    Time frame: 3 Years

    Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes

  10. Target Vessel Revascularization (TVR)

    Time frame: 30 Days

    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.

  11. Target Vessel Revascularization (TVR)

    Time frame: 9 Months

    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.

  12. Target Vessel Revascularization (TVR)

    Time frame: 1 Year

    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.

  13. Target Vessel Revascularization (TVR)

    Time frame: 2 Years

    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.

  14. Target Vessel Revascularization (TVR)

    Time frame: 3 Years

    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.

  15. Myocardial Infarction (MI)

    Time frame: Index hospitalization

    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.

  16. Technical Success

    Time frame: Index procedure

    Residual lesion stenosis <=30% based on visual assessment immediately postprocedure

  17. Procedure Success

    Time frame: In hospital (1-2 days post procedure)

    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).

  18. Early Clinical Success

    Time frame: Hospital Discharge

    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

  19. Early Clinical Success

    Time frame: 30 Days

    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

  20. Late Clinical Success

    Time frame: 9 Months

    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

  21. Late Clinical Success

    Time frame: 1 Year

    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

  22. Early Hemodynamic Success

    Time frame: Hospital Discharge

    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.

  23. Early Hemodynamic Success

    Time frame: 30 Days

    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.

  24. Late Hemodynamic Success

    Time frame: 9 Months

    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.

  25. Late Hemodynamic Success

    Time frame: 1 Year

    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.

  26. Rutherford Classification Distribution

    Time frame: Pre-procedure/baseline

    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

  27. Rutherford Classification Distribution

    Time frame: Post-procedure

    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

  28. Rutherford Classification Distribution

    Time frame: 30 Days

    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

  29. Rutherford Classification Distribution

    Time frame: 9 Months

    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

  30. Rutherford Classification Distribution

    Time frame: 1 Year

    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

  31. Acute Stent Thrombosis

    Time frame: 24 Hours

    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.

  32. Sub-acute Stent Thrombosis

    Time frame: >24 Hours to <=30 Days Post-index procedure

    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.

  33. Stent Thrombosis

    Time frame: 9 Months

    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.

  34. Stent Thrombosis

    Time frame: 1 Year

    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.

  35. Stent Thrombosis

    Time frame: 2 Years

    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.

  36. Stent Thrombosis

    Time frame: 3 Years

    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.

  37. Target Lesion Revascularization (TLR)

    Time frame: 30 Days

    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.

  38. Target Lesion Revascularization (TLR)

    Time frame: 9 Months

    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.

  39. Target Lesion Revascularization (TLR)

    Time frame: 1 Year

    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.

  40. Target Lesion Revascularization (TLR)

    Time frame: 2 Years

    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.

  41. Target Lesion Revascularization (TLR)

    Time frame: 3 Years

    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.

  42. Ankle-Brachial Index (ABI)

    Time frame: Pre-procedure/baseline

    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.

  43. Ankle-Brachial Index

    Time frame: Hospital Discharge (1-2 days post-procedure)

    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.

  44. Ankle-Brachial Index (ABI)

    Time frame: 30 Days

    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.

  45. Ankle-Brachial Index (ABI)

    Time frame: 9 Months

    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.

  46. Ankle-Brachial Index (ABI)

    Time frame: 1 Year

    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.

  47. Primary Patency

    Time frame: 9 Months

    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.

  48. Primary Patency

    Time frame: 1 Year

    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.

  49. Primary-assisted Patency (PAP)

    Time frame: 9 Months

    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.

  50. Primary-assisted Patency (PAP)

    Time frame: 1 Year

    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.

  51. Secondary Patency

    Time frame: 9 Months

    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.

  52. Secondary Patency

    Time frame: 1 Year

    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.

  53. Restenosis Assessed by Duplex Ultrasound

    Time frame: 9 Months

    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.

  54. Restenosis Assessed by Duplex Ultrasound

    Time frame: 1 Year

    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.

  55. Walking Impairment Questionnaire Score - Distance

    Time frame: Pre-procedure/baseline

    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.

  56. Walking Impairment Questionnaire Score - Distance

    Time frame: 9 Months

    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.

  57. Walking Impairment Questionnaire Score - Distance

    Time frame: 1 Year

    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.

  58. Walking Impairment Questionnaire Score - Speed

    Time frame: Pre-procedure/baseline

    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.

  59. Walking Impairment Questionnaire Score - Speed

    Time frame: 9 Months

    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.

  60. Walking Impairment Questionnaire Score - Speed

    Time frame: 1 Year

    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.

  61. Walking Impairment Questionnaire Score-Stair Climbing

    Time frame: Pre-procedure/baseline

    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.

  62. Walking Impairment Questionnaire Score - Stair Climbing

    Time frame: 9 Months

    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.

  63. Walking Impairment Questionnaire Score - Stair Climbing

    Time frame: 1 Year

    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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Acronym: ORION

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
May 11, 2009
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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