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

May 8, 2009
January 10, 2014
May 2009
September 2011   (final data collection date for primary outcome measure)
Device- and/or Procedure-related Major Adverse Events (MAE) [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
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
Device- and/or procedure-related major adverse event (MAE)* rate, adjudicated by an independent clinical events committee. [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00896337 on ClinicalTrials.gov Archive Site
  • Death [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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
  • Death [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
    Death is classified as follows. Cardiac death: death due to immediate cardiac caus,; 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
  • Amputation of Index Limb [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
    Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
  • Target Vessel Revascularization (TVR) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

    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.

  • Target Vessel Revascularization (TVR) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]

    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.

  • Myocardial Infarction (MI) [ Time Frame: Index hospitalization ] [ Designated as safety issue: Yes ]
    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.
  • Early Clinical Success [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    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

  • Late Clinical Success [ Time Frame: 9 Months ] [ Designated as safety issue: No ]

    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

  • Rutherford Classification Distribution [ Time Frame: Pre-procedure/baseline ] [ Designated as safety issue: No ]

    Rutherford Classification is used to assess lower extremity ischemia as shown below:

    0 = Asymptomatic

    1. = Mild claudication
    2. = Moderate claudication
    3. = Severe claudication
    4. = Ischemic rest pain
    5. = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema
  • Rutherford Classification Distribution [ Time Frame: 9 Months ] [ Designated as safety issue: No ]

    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

  • Acute Stent Thrombosis [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    • 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.

  • Sub-acute Stent Thrombosis [ Time Frame: >24 hours to <=30 days post-index procedure ] [ Designated as safety issue: Yes ]
    • 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.
  • Target Lesion Revascularization (TLR) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    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.
  • Target Lesion Revascularization (TLR) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    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.
  • Technical Success [ Time Frame: Index procedure ] [ Designated as safety issue: No ]
    Residual lesion stenosis <=30% based on visual assessment immediately postprocedure
  • Procedure Success [ Time Frame: In hospital (1-2 days post procedure) ] [ Designated as safety issue: Yes ]
    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).
  • Ankle-Brachial Index (ABI) [ Time Frame: Pre-procedure/baseline ] [ Designated as safety issue: No ]

    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.

  • Ankle-Brachial Index [ Time Frame: Hospital Discharge (1-2 days post-procedure) ] [ Designated as safety issue: No ]

    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.

  • Ankle-Brachial Index (ABI) [ Time Frame: 9 Months ] [ Designated as safety issue: No ]

    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.

  • Late Hemodynamic Success [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    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.
  • Primary Patency [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.
  • Primary-assisted Patency (PAP) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.
  • Secondary Patency [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    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.
  • Restenosis Assessed by Duplex Ultrasound [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    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.
  • Walking Impairment Questionnaire Score - Distance [ Time Frame: Pre-procedure/baseline ] [ Designated as safety issue: No ]
    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.
  • Walking Impairment Questionnaire Score - Distance [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    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.
  • Walking Impairment Questionnaire Score - Speed [ Time Frame: Pre-procedure/baseline ] [ Designated as safety issue: No ]
    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.
  • Walking Impairment Questionnaire Score - Speed [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    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.
  • Walking Impairment Questionnaire Score-Stair Climbing [ Time Frame: Pre-procedure/baseline ] [ Designated as safety issue: No ]
    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.
  • Walking Impairment Questionnaire Score - Stair Climbing [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    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.
  • Improvement in Rutherford classification by 1 class as compared to baseline [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: No ]
  • Frequency distribution of Rutherford classification [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: No ]
  • Improvement in ABI by 0.1 as compared to baseline. [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: No ]
  • Target vessel revascularization [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: Yes ]
  • Amputation of index limb [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 9 and 12 Months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
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.

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Iliac Artery Stenosis
  • 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.
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.
Interventions:
  • Device: Epic™ Nitinol Stent System
  • Drug: Anti-platelet therapy
  • Drug: Anti-coagulation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
December 2013
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00896337
S2020
Yes
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Study Director: Pamela G. Grady, Ph.D. Boston Scientific Corporation
Principal Investigator: Daniel G Clair, MD The Cleveland Clinic
Boston Scientific Corporation
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP