Iliac Artery Stenosis
Conditions
Keywords
iliac artery stenosis, claudication, atherosclerotic iliac disease, peripheral vascular disease
Brief summary
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.
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.
Interventions
DEVICEEpic™ Nitinol Stent System
The Epic™ Nitinol Stent System is comprised of two components: the implantable nitinol endoprosthesis and the stent delivery system.
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.
DRUGAnti-coagulation therapy
Anti-coagulation therapy must be administered during the procedure consistent with current clinical practice.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device- and/or Procedure-related Major Adverse Events (MAE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Death | 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 |
| Amputation of Index Limb | 9 Months | Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes |
| Target Vessel Revascularization (TVR) | 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. |
| Myocardial Infarction (MI) | 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. |
| Technical Success | Index procedure | Residual lesion stenosis \<=30% based on visual assessment immediately postprocedure |
| Early Hemodynamic Success | 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. |
| Procedure Success | 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). |
| Early Clinical Success | 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 |
| Late Clinical Success | 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 |
| Late Hemodynamic Success | 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. |
| Rutherford Classification Distribution | Pre-procedure/baseline | 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 |
| Acute Stent Thrombosis | 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. |
| Sub-acute Stent Thrombosis | >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. |
| Stent Thrombosis | 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. |
| Target Lesion Revascularization (TLR) | 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. |
| Ankle-Brachial Index (ABI) | 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. |
| Ankle-Brachial Index | 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. |
| Primary Patency | 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. |
| Primary-assisted Patency (PAP) | 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. |
| Secondary Patency | 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. |
| Restenosis Assessed by Duplex Ultrasound | 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. |
| Walking Impairment Questionnaire Score - Distance | 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. |
| Walking Impairment Questionnaire Score - Speed | 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. |
| Walking Impairment Questionnaire Score-Stair Climbing | 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. |
| Walking Impairment Questionnaire Score - Stair Climbing | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 125 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 7 |
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | ORION |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 45 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants |
| Age, Continuous | 61.1 years STANDARD_DEVIATION 9.3 |
| Cardiac History History of Congestive Heart Failure | 10 Participants |
| Cardiac History History of Coronary Artery Disease | 73 Participants |
| Cardiac History History of Myocardial Infarction | 36 Participants |
| Cardiac History Previous Coronary Artery Bypass Graft | 22 Participants |
| Cardiac History Previous Percutaneous Coronary Intervention | 46 Participants |
| Cardiac History Silent Ischemia | 0 Participants |
| Cardiac History Stable Angina | 15 Participants |
| Cardiac History Unstable Angina | 1 Participants |
| General Medical History History of Chronic Obstructive Pulmonary Disease | 31 Participants |
| General Medical History Hyperlipidemia Requiring Medication | 98 Participants |
| General Medical History Hypertension Requiring Medication | 95 Participants |
| General Medical History Medically Treated Diabetes | 42 Participants |
| General Medical History Smoking, Ever | 121 Participants |
| Lesion Characteristic: Diameter Stenosis | 71.51 percent STANDARD_DEVIATION 16.27 |
| Lesion Characteristic: Lesion Location Distal | 13 Lesions |
| Lesion Characteristic: Lesion Location Mid | 12 Lesions |
| Lesion Characteristic: Lesion Location Ostial | 100 Lesions |
| Lesion Characteristic: Lesion Location Proximal | 35 Lesions |
| Lesion Characteristics > 45 Degree Bend | 1 Lesions |
| Lesion Characteristics > 90 Degree Bend | 0 Lesions |
| Lesion Characteristics Aneurysm | 10 Lesions |
| Lesion Characteristics Calcification, Moderate | 45 Lesions |
| Lesion Characteristics Calcification, Non/Mild | 37 Lesions |
| Lesion Characteristics Calcification, Severe | 78 Lesions |
| Lesion Characteristics Concentric Lesion | 72 Lesions |
| Lesion Characteristics Eccentric Lesion | 88 Lesions |
| Lesion Characteristics Thrombus | 0 Lesions |
| Lesion Characteristics Total Occlusion | 26 Lesions |
| Lesion Characteristics Ulcerated | 29 Lesions |
| Lesion Characteristics: Size Lesion Length | 31.04 millimeters STANDARD_DEVIATION 22.13 |
| Lesion Characteristics: Size Minimum Lumen Diameter | 2.20 millimeters STANDARD_DEVIATION 1.34 |
| Lesion Characteristics: Size Reference Vessel Diameter | 7.69 millimeters STANDARD_DEVIATION 1.79 |
| Lesion Characteristic: Target Lesion Vessel Left Common Iliac Artery | 58 Lesions |
| Lesion Characteristic: Target Lesion Vessel Left External Iliac Artery | 16 Lesions |
| Lesion Characteristic: Target Lesion Vessel Right Common Iliac Artery | 58 Lesions |
| Lesion Characteristic: Target Lesion Vessel Right External Iliac Artery | 28 Lesions |
| Neurologic/Renal History History of Cerebrovascular Accident | 7 participants |
| Neurologic/Renal History History of Renal Insufficiency | 9 participants |
| Neurologic/Renal History History of Renal Percutaneous Intervention | 6 participants |
| Neurologic/Renal History History of Transient Ischemic Attack | 5 participants |
| Peripheral Vascular History History of Claudication | 116 Participants |
| Peripheral Vascular History History of Other Peripheral Endovascular Intervent | 25 Participants |
| Peripheral Vascular History History of Peripheral Vascular Surgery | 10 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants |
| Race/Ethnicity, Customized Asian | 0 participants |
| Race/Ethnicity, Customized Black of African heritage | 8 participants |
| Race/Ethnicity, Customized Caucasian | 112 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Region of Enrollment United States | 125 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 63 / 125 |
| serious Total, serious adverse events | 77 / 125 |
Outcome results
Primary
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
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Device- and/or Procedure-related Major Adverse Events (MAE) | 3.4 percentage of participants |
Comparison: MAE rate was compared to a predefined performance goal of 17.0%, based on literature-derived expected rate of 8.0% for iliac stenting plus a 9.0% margin. Study had 87% statistical power to show the MAE rate (accounting for 9-month attrition of \<=15%) is less than the performance goal, assuming a 9-month MAE rate of 8.0%. If the exact one-sided 95% upper confidence bound of the observed rate is lower than the performance goal, the Epic stent would be considered to have acceptable performance.p-value: <0.000195% CI: [0.9, 8.5]One-sided exact-test
Secondary
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.
Time frame: 24 Hours
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Acute Stent Thrombosis | 0.0 percentage of participants |
Secondary
Amputation of Index Limb
Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Amputation of Index Limb | 0 percentage of participants |
Secondary
Amputation of Index Limb
Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Time frame: 3 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Amputation of Index Limb | 0 percentage of participants |
Secondary
Amputation of Index Limb
Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Time frame: 2 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Amputation of Index Limb | 0 percentage of participants |
Secondary
Amputation of Index Limb
Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Amputation of Index Limb | 0.0 percentage of participants |
Secondary
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.
Time frame: Hospital Discharge (1-2 days post-procedure)
Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Ankle-Brachial Index | 0.96 ratio | Standard Deviation 0.17 |
Secondary
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.
Time frame: Pre-procedure/baseline
Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Ankle-Brachial Index (ABI) | 0.79 ratio | Standard Deviation 0.18 |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Ankle-Brachial Index (ABI) | 0.96 ratio | Standard Deviation 0.17 |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Ankle-Brachial Index (ABI) | 0.97 ratio | Standard Deviation 0.17 |
Secondary
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.
Time frame: 30 Days
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Ankle-Brachial Index (ABI) | 0.99 ratio | Standard Deviation 0.015 |
Secondary
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
Time frame: 30 Days
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Death | 0.0 percentage of participants |
Secondary
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
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Death | 1.8 percentage of participants |
Secondary
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
Time frame: 2 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 17 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Death | 3.7 percentage of participants |
Secondary
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
Time frame: 3 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 18 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Death | 6.5 percentage of participants |
Secondary
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
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Death | 0.8 percentage of participants |
Secondary
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
Time frame: 30 Days
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Early Clinical Success | 87.6 percentage of participants |
Secondary
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
Time frame: Hospital Discharge
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Early Clinical Success | 44.2 percentage of participants |
Secondary
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.
Time frame: 30 Days
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Early Hemodynamic Success | 66.2 percentage of limbs |
Secondary
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.
Time frame: Hospital Discharge
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Early Hemodynamic Success | 61.2 percentage of limbs |
Secondary
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
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 16 participants not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Late Clinical Success | 89.9 percentage of patients |
Secondary
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
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 19 participants not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Late Clinical Success | 95.3 percentage of patients |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 8 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Late Hemodynamic Success | 66.7 percentage of limbs |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Late Hemodynamic Success | 63.6 percentage of limbs |
Secondary
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.
Time frame: Index hospitalization
Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Myocardial Infarction (MI) | 0.0 percentage of participants |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Primary-assisted Patency (PAP) | 96.0 percentage of lesions |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Primary-assisted Patency (PAP) | 98.4 percentage of lesions |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Primary Patency | 95.9 percentage of lesions |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Primary Patency | 93.9 percentage of lesions |
Secondary
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).
Time frame: In hospital (1-2 days post procedure)
Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Procedure Success | 99.2 percentage of participants |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Restenosis Assessed by Duplex Ultrasound | 6.1 percentage of lesions |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Restenosis Assessed by Duplex Ultrasound | 2.5 percentage of lesions |
Secondary
Rutherford Classification Distribution
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
Time frame: 30 Days
Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epic Stent | Rutherford Classification Distribution | Asymptomatic | 65.6 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Mild Claudication | 16.8 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Moderate Claudication | 13.3 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Severe Claudication | 4.4 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Ischemic Rest Pain | 0 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Minor Tissue Loss | 0 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Major Tissue Loss | 0 percentage of participants |
Secondary
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
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 19 participants not evaluable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epic Stent | Rutherford Classification Distribution | Asymptomatic | 76.4 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Mild Claudication | 12.3 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Moderate Claudication | 10.4 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Severe Claudication | 0.9 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Ischemic Rest Pain | 0 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Minor Tissue Loss | 0 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Major Tissue Loss | 0 percentage of participants |
Secondary
Rutherford Classification Distribution
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
Time frame: Pre-procedure/baseline
Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epic Stent | Rutherford Classification Distribution | Asymptomatic | 0.0 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Mild Claudication | 7.2 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Moderate Claudication | 33.6 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Severe Claudication | 54.4 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Ischemic Rest Pain | 4.8 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Minor Tissue Loss | 0.0 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Major Tissue Loss | 0.0 percentage of participants |
Secondary
Rutherford Classification Distribution
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
Time frame: Post-procedure
Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epic Stent | Rutherford Classification Distribution | Asymptomatic | 17.7 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Mild Claudication | 20.4 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Moderate Claudication | 35.4 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Severe Claudication | 23.0 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Ischemic Rest Pain | 3.5 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Minor Tissue Loss | 0 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Major Tissue Loss | 0 percentage of participants |
Secondary
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
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 16 participants not evaluable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Epic Stent | Rutherford Classification Distribution | Asymptomatic | 63.3 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Mild Claudication | 18.3 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Moderate Claudication | 15.6 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Severe Claudication | 2.8 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Ischemic Rest Pain | 0.0 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Minor Tissue Loss | 0.0 percentage of participants |
| Epic Stent | Rutherford Classification Distribution | Major Tissue Loss | 0.0 percentage of participants |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 31 participants were not evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Secondary Patency | 100 percentage of lesions |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Secondary Patency | 98.0 percentage of lesions |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Stent Thrombosis | 2.5 percentage of participants |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Stent Thrombosis | 2.7 percentage of participants |
Secondary
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.
Time frame: 2 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Stent Thrombosis | 2.8 percentage of participants |
Secondary
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.
Time frame: 3 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Stent Thrombosis | 4.0 percentage of participants |
Secondary
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.
Time frame: >24 Hours to <=30 Days Post-index procedure
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Sub-acute Stent Thrombosis | 2.5 percentage of participants |
Secondary
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.
Time frame: 2 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Target Lesion Revascularization (TLR) | 5.6 percentage of lesions |
Secondary
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.
Time frame: 30 Days
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Target Lesion Revascularization (TLR) | 1.9 percentage of lesions |
Secondary
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.
Time frame: 3 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Target Lesion Revascularization (TLR) | 10.1 percentage of lesions |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Target Lesion Revascularization (TLR) | 3.3 percentage of lesions |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Target Lesion Revascularization (TLR) | 3.2 percentage of lesions |
Secondary
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.
Time frame: 2 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Target Vessel Revascularization (TVR) | 8.5 percentage of participants |
Secondary
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.
Time frame: 3 Years
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Target Vessel Revascularization (TVR) | 12.9 percentage of participants |
Secondary
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.
Time frame: 30 Days
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Target Vessel Revascularization (TVR) | 2.5 percentage of participants |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Target Vessel Revascularization (TVR) | 3.6 percentage of participants |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Target Vessel Revascularization (TVR) | 3.4 percentage of participants |
Secondary
Technical Success
Residual lesion stenosis \<=30% based on visual assessment immediately postprocedure
Time frame: Index procedure
Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Epic Stent | Technical Success | 100 percentage of lesions |
Secondary
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.
Time frame: Pre-procedure/baseline
Population: Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Walking Impairment Questionnaire Score - Distance | 14.56 units on a scale | Standard Deviation 19.36 |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Walking Impairment Questionnaire Score - Distance | 56.35 units on a scale | Standard Deviation 38.97 |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Walking Impairment Questionnaire Score - Distance | 55.88 units on a scale | Standard Deviation 38.02 |
Secondary
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.
Time frame: Pre-procedure/baseline
Population: Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Walking Impairment Questionnaire Score - Speed | 18.38 units on a scale | Standard Deviation 19.18 |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Walking Impairment Questionnaire Score - Speed | 48.45 units on a scale | Standard Deviation 31.5 |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Walking Impairment Questionnaire Score - Speed | 47.96 units on a scale | Standard Deviation 31.8 |
Secondary
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.
Time frame: 9 Months
Population: Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 15 participants were not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Walking Impairment Questionnaire Score - Stair Climbing | 59.39 units on a scale | Standard Deviation 38.08 |
Secondary
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.
Time frame: 1 Year
Population: Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 17 participants were not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Walking Impairment Questionnaire Score - Stair Climbing | 57.72 units on a scale | Standard Deviation 37.17 |
Secondary
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.
Time frame: Pre-procedure/baseline
Population: Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epic Stent | Walking Impairment Questionnaire Score-Stair Climbing | 26.14 units on a scale | Standard Deviation 26.91 |