Atherosclerosis of Native Arteries of the Extremities
Conditions
Keywords
atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), lower extremities, stenting, paclitaxel
Brief summary
The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length. Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.
Detailed description
Atherosclerosis is a systemic disease that has become increasingly recognized in the expanding elderly population as a significant cause of morbidity and mortality. Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms ranging from intermittent claudication to ischemic rest pain and critical ischemia with major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully treat with endovascular therapy because the disease is often diffuse and located in an area of the body subject to significant mobility stresses such as extension, contraction, compression, elongation, flexion and torsion. The IMPERIAL trial is a global, prospective, multi-center trial. Approximately 525-535 subjects will be enrolled at up to 75 study centers worldwide. Regions participating include the United States, Canada, European Union, Japan and New Zealand. The trial consists of a prospective, multicenter, 2:1 randomized (ELUVIA vs Zilver PTX), controlled, single-blind, non-inferiority trial (RCT), a concurrent, non-blinded, non-randomized, single-arm, pharmacokinetic (PK) substudy and a concurrent, non-blinded, non-randomized, Long Lesion substudy.
Interventions
DEVICEELUVIA (Stent Implantation)
Drug-eluting self-expanding stent implantation during the index procedure.
DEVICEZilver PTX (Stent Implantation)
Drug-eluting self-expanding stent implantation during the index procedure.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects age 18 and older. 2. Subject (or Legal Guardian if applicable) is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits. NOTE: For subjects less than 20 years of age enrolled at a Japanese center, the subject's legal representative, as well as the subject, must provide written informed consent. 3. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4. 4. Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA: * Degree of stenosis ≥ 70% by visual angiographic assessment * Vessel diameter ≥ 4 and ≤ 6 mm * Total lesion length (or series of lesions) ≥ 30 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one ELUVIA stent or up to two Zilver PTX stents) * Long Lesion Substudy: Total lesion length (or series of lesions) \>140 mm and ≤ 190 mm (Note: Lesion segment(s) will require overlapping of two ELUVIA stents). * For occlusive lesions requiring use of re-entry device, lesion length ≤ 120 mm * Long Lesion Substudy: For occlusive lesions requiring use of re-entry device, lesion length \> 120 mm and ≤ 170 mm * Target lesion located at least three centimeters above the inferior edge of the femur 5. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\<50% stenosis) to the ankle or foot with no planned intervention.
Exclusion criteria
1. Previously stented target lesion/vessel. 2. Target lesion/vessel previously treated with drug-coated balloon \<12 months prior to randomization/enrollment. 3. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease. 4. Use of atherectomy, laser or other debulking devices in the target limb SFA/PPA during the index procedure. 5. History of major amputation in the target limb. 6. Documented 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 clinical trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical trial. 7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated. 8. Known hypersensitivity/allergy to the investigational stent system or protocol related therapies (e.g., nitinol, paclitaxel, or structurally related compounds, polymer or individual components, and antiplatelet, anticoagulant, thrombolytic medications). 9. Platelet count \<80,000 mm3 or \>600,000 mm3 or history of bleeding diathesis. 10. Concomitant renal failure with a serum creatinine \>2.0 mg/dL. 11. Receiving dialysis or immunosuppressant therapy. 12. History of myocardial infarction (MI) or stroke/cerebrovascular accident (CVA) within 6 months prior to randomization/enrollment. 13. Unstable angina pectoris at the time of randomization/enrollment. 14. Pregnant, breast feeding, or plan to become pregnant in the next 5 years. 15. Current participation in another investigational drug or device clinical study that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current study endpoints (Note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies). 16. Septicemia at the time of randomization/enrollment. 17. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of randomization/enrollment. 18. Presence of aneurysm in the target vessel. 19. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to randomization/enrollment. 20. Perforated vessel as evidenced by extravasation of contrast media prior to randomization/enrollment. 21. Heavily calcified lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reaching Primary Patency | 12 Months | Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory |
| Percentage of Participants With Major Adverse Events (MAEs) | 12 Months | MAEs defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization (TLR) through 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants Meeting Primary Sustained Clinical Improvement | 12 Months | Defined as improvement in Rutherford classification (defined as chronic, symptomatic lower limb ischemia in categories 2, 3 or 4) by one or more categories compared with baseline, without target lesion revascularization. |
| Number of Participants With Hemodynamic Improvement | 12 Months | Defined as an increase in the ankle-brachial index by greater than of equal to 0.10 compared with baseline or to an ankle-brachial index of greater than or equal to 0.90, without need for repeat target lesion revascularization. |
| Number of CEC-adjudicated Events Through 12 Months | 12 Months | Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window. |
| Walking Impairment Questionnaire (WIQ) Scores | Baseline to 12 Months | The WIQ 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. WIQ scores reported as change from baseline. |
| 6-Minute Walk Test - Distance Walked | Change in baseline to 12-Months | Change in distance walked from baseline to 12 months. |
| 6-Minute Walk Test - Speed | Baseline to 12 months | Change in speed walked from baseline to 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Major Adverse Events | Through 60 Months | Percentage of participants without Major Adverse Events (MAEs) |
| Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate | Through 60 Months | Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization rate |
| Percentage of Participants With Target Limb Major Amputation | Through 60 Months | Clinical Events Committee (CEC) adjudicated target limb major amputation rate |
Countries
Austria, Belgium, Canada, Germany, Japan, New Zealand, United States
Participant flow
Pre-assignment details
A total of 524 subjects have been enrolled in the IMPERIAL trial, including 465 subjects in the RCT, 50 subjects in the LL substudy and 13 subjects in the PK substudy. There were 4 subjects enrolled in both the PK and Long Lesion substudy.
Participants by arm
| Arm | Count |
|---|---|
| ELUVIA Stent Implantation Percutaneous stent placement in the SFA/PPA
ELUVIA (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure. | 309 |
| Zilver PTX Stent Implantation Percutaneous stent placement in the SFA/PPA
Zilver PTX (Stent Implantation): Drug-eluting self-expanding stent implantation during the index procedure. | 156 |
| Long Lesion Substudy Long Lesion Substudy Cohort will evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length. | 50 |
| PK Substudy PK Substudy Cohort will evaluate the safety and pharmacokinetics of the ELUVIA stent for the treatment of atherosclerotic lesion(s) up to 140 mm in length in the SFA/PPAPK. Time-points for analysis are baseline venous blood drawn followed by blood draws at 10 minutes, 30 minutes, 1, 2, 3, 4, 6, 12, and 24 hours and one final blood draw at either 48 hours or 72 hours after placement of the ELUVIA stent. | 13 |
| Total | 528 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 | 1 | 0 |
| Overall Study | Death | 48 | 26 | 12 | 4 |
| Overall Study | Lost to Follow-up | 5 | 1 | 3 | 0 |
| Overall Study | Other | 7 | 2 | 0 | 0 |
| Overall Study | Physician Decision | 5 | 2 | 0 | 0 |
| Overall Study | Visit Missed | 15 | 7 | 5 | 0 |
| Overall Study | Withdrawal by Subject | 29 | 15 | 4 | 1 |
Baseline characteristics
| Characteristic | ELUVIA Stent Implantation | Zilver PTX Stent Implantation | Total | PK Substudy | Long Lesion Substudy |
|---|---|---|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 9.5 | 67.8 years STANDARD_DEVIATION 9.4 | 68.3 years STANDARD_DEVIATION 9.3 | 66.4 years STANDARD_DEVIATION 6.1 | 68.2 years STANDARD_DEVIATION 8.9 |
| Current Diabetes Mellitus | 129 Participants | 68 Participants | 224 Participants | 7 Participants | 20 Participants |
| History of Cerebrovascular Accident (CVA) | 30 Participants | 14 Participants | 57 Participants | 4 Participants | 9 Participants |
| History of Chronic Obstructive Pulmonary Disease | 48 Participants | 28 Participants | 87 Participants | 2 Participants | 9 Participants |
| History of Claudication | 303 Participants | 151 Participants | 516 Participants | 13 Participants | 49 Participants |
| History of Congestive Heart Failure (CHF) | 26 Participants | 12 Participants | 47 Participants | 1 Participants | 8 Participants |
| History of Coronary Artery Bypass Surgery (CABG) | 43 Participants | 21 Participants | 74 Participants | 3 Participants | 7 Participants |
| History of Coronary Artery Disease (CAD) | 156 Participants | 70 Participants | 261 Participants | 7 Participants | 28 Participants |
| History of endovascular interventions in Target Vessel | 27 Participants | 17 Participants | 47 Participants | 1 Participants | 2 Participants |
| History of Hyperlipidemia requiring medication | 235 Participants | 118 Participants | 406 Participants | 12 Participants | 41 Participants |
| History of Hypertension requiring medication | 254 Participants | 133 Participants | 445 Participants | 12 Participants | 46 Participants |
| History of Myocardial Infarction (MI) | 60 Participants | 27 Participants | 98 Participants | 2 Participants | 9 Participants |
| History of Other Peripheral Endovascular Interventions (other than Target Vessel) | 112 Participants | 49 Participants | 186 Participants | 5 Participants | 20 Participants |
| History of Percutaneous Coronary Intervention (PCI) | 100 Participants | 53 Participants | 174 Participants | 3 Participants | 18 Participants |
| History of Peripheral Vascular Surgery | 40 Participants | 15 Participants | 58 Participants | 1 Participants | 2 Participants |
| History of Renal insufficiency | 25 Participants | 11 Participants | 41 Participants | 2 Participants | 3 Participants |
| History of Renal Percutaneous Intervention | 6 Participants | 1 Participants | 7 Participants | 0 Participants | 0 Participants |
| History of Smoking (Current) | 109 Participants | 63 Participants | 191 Participants | 3 Participants | 16 Participants |
| History of Smoking (Never) | 42 Participants | 22 Participants | 72 Participants | 0 Participants | 8 Participants |
| History of Smoking (Previous) | 157 Participants | 68 Participants | 261 Participants | 10 Participants | 26 Participants |
| History of Smoking (Unknown) | 1 Participants | 3 Participants | 4 Participants | 0 Participants | 0 Participants |
| History of Transient Ischemic Attacks (TIA) | 14 Participants | 6 Participants | 26 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 2 Participants | 4 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black, or African Heritage | 21 Participants | 11 Participants | 38 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 205 Participants | 108 Participants | 356 Participants | 13 Participants | 30 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 18 Participants | 6 Participants | 27 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Japanese | 56 Participants | 28 Participants | 95 Participants | 0 Participants | 11 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Disclosed | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Canada | 17 participants | 7 participants | 24 participants | 0 participants | 0 participants |
| Region of Enrollment Europe | 89 participants | 44 participants | 137 participants | 0 participants | 4 participants |
| Region of Enrollment Japan | 56 participants | 28 participants | 95 participants | 0 participants | 11 participants |
| Region of Enrollment New Zealand | 9 participants | 5 participants | 15 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 138 participants | 72 participants | 257 participants | 13 participants | 34 participants |
| Sex: Female, Male Female | 105 Participants | 52 Participants | 178 Participants | 3 Participants | 18 Participants |
| Sex: Female, Male Male | 204 Participants | 104 Participants | 350 Participants | 10 Participants | 32 Participants |
| Stable Angina | 32 Participants | 19 Participants | 56 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 58 / 309 | 28 / 156 | 13 / 50 | 6 / 13 |
| other Total, other adverse events | 186 / 309 | 91 / 156 | 27 / 50 | 11 / 13 |
| serious Total, serious adverse events | 243 / 309 | 126 / 156 | 40 / 50 | 13 / 13 |
Outcome results
Primary
Number of Participants Reaching Primary Patency
Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory
Time frame: 12 Months
Population: Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without clinically-driven TLR or, bypass of the target lesion before or on the DUS FU visit. Per PK sub-study design, primary efficacy (patency) not analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ELUVIA Stent Implantation | Number of Participants Reaching Primary Patency | 231 Participants |
| Zilver PTX Stent Implantation | Number of Participants Reaching Primary Patency | 106 Participants |
| Long Lesion Substudy | Number of Participants Reaching Primary Patency | 40 Participants |
p-value: <0.0001Farrington-Manning
Primary
Percentage of Participants With Major Adverse Events (MAEs)
MAEs defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization (TLR) through 12 months
Time frame: 12 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ELUVIA Stent Implantation | Percentage of Participants With Major Adverse Events (MAEs) | All Causes of Death at 1 Month | 0 percentage of participants |
| ELUVIA Stent Implantation | Percentage of Participants With Major Adverse Events (MAEs) | Target Lesion Revascularization | 4.5 percentage of participants |
| ELUVIA Stent Implantation | Percentage of Participants With Major Adverse Events (MAEs) | Target Limb Major Amputation | 0.3 percentage of participants |
| Zilver PTX Stent Implantation | Percentage of Participants With Major Adverse Events (MAEs) | All Causes of Death at 1 Month | 0 percentage of participants |
| Zilver PTX Stent Implantation | Percentage of Participants With Major Adverse Events (MAEs) | Target Lesion Revascularization | 9.0 percentage of participants |
| Zilver PTX Stent Implantation | Percentage of Participants With Major Adverse Events (MAEs) | Target Limb Major Amputation | 0 percentage of participants |
| Long Lesion Substudy | Percentage of Participants With Major Adverse Events (MAEs) | Target Limb Major Amputation | 0 percentage of participants |
| Long Lesion Substudy | Percentage of Participants With Major Adverse Events (MAEs) | All Causes of Death at 1 Month | 0 percentage of participants |
| Long Lesion Substudy | Percentage of Participants With Major Adverse Events (MAEs) | Target Lesion Revascularization | 6.5 percentage of participants |
| PK Substudy | Percentage of Participants With Major Adverse Events (MAEs) | All Causes of Death at 1 Month | 0 percentage of participants |
| PK Substudy | Percentage of Participants With Major Adverse Events (MAEs) | Target Lesion Revascularization | 0 percentage of participants |
| PK Substudy | Percentage of Participants With Major Adverse Events (MAEs) | Target Limb Major Amputation | 0 percentage of participants |
p-value: <0.0001Farrington-Manning
Secondary
6-Minute Walk Test - Distance Walked
Change in distance walked from baseline to 12 months.
Time frame: Change in baseline to 12-Months
Population: Per PK sub-study design, secondary endpoint not analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ELUVIA Stent Implantation | 6-Minute Walk Test - Distance Walked | 323.8 m | Standard Deviation 148.5 |
| Zilver PTX Stent Implantation | 6-Minute Walk Test - Distance Walked | 323.4 m | Standard Deviation 155.4 |
| Long Lesion Substudy | 6-Minute Walk Test - Distance Walked | 293.5 m | Standard Deviation 123.8 |
Secondary
6-Minute Walk Test - Speed
Change in speed walked from baseline to 12 months
Time frame: Baseline to 12 months
Population: Per PK sub-study design, secondary endpoint not analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ELUVIA Stent Implantation | 6-Minute Walk Test - Speed | 55.5 m/min | Standard Deviation 23.3 |
| Zilver PTX Stent Implantation | 6-Minute Walk Test - Speed | 56.1 m/min | Standard Deviation 24.1 |
| Long Lesion Substudy | 6-Minute Walk Test - Speed | 50.3 m/min | Standard Deviation 19.3 |
Secondary
Count of Participants Meeting Primary Sustained Clinical Improvement
Defined as improvement in Rutherford classification (defined as chronic, symptomatic lower limb ischemia in categories 2, 3 or 4) by one or more categories compared with baseline, without target lesion revascularization.
Time frame: 12 Months
Population: Per PK sub-study design, secondary endpoint not analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ELUVIA Stent Implantation | Count of Participants Meeting Primary Sustained Clinical Improvement | 250 Participants |
| Zilver PTX Stent Implantation | Count of Participants Meeting Primary Sustained Clinical Improvement | 118 Participants |
| Long Lesion Substudy | Count of Participants Meeting Primary Sustained Clinical Improvement | 35 Participants |
Secondary
Number of CEC-adjudicated Events Through 12 Months
Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window.
Time frame: 12 Months
Population: Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ELUVIA Stent Implantation | Number of CEC-adjudicated Events Through 12 Months | Stent Thrombosis | 5 participants |
| ELUVIA Stent Implantation | Number of CEC-adjudicated Events Through 12 Months | Target Vessel Revascularization | 20 participants |
| ELUVIA Stent Implantation | Number of CEC-adjudicated Events Through 12 Months | Target Lesion Revascularization | 13 participants |
| ELUVIA Stent Implantation | Number of CEC-adjudicated Events Through 12 Months | Target Limb Amputation | 1 participants |
| ELUVIA Stent Implantation | Number of CEC-adjudicated Events Through 12 Months | All deaths | 6 participants |
| Zilver PTX Stent Implantation | Number of CEC-adjudicated Events Through 12 Months | All deaths | 6 participants |
| Zilver PTX Stent Implantation | Number of CEC-adjudicated Events Through 12 Months | Stent Thrombosis | 6 participants |
| Zilver PTX Stent Implantation | Number of CEC-adjudicated Events Through 12 Months | Target Lesion Revascularization | 13 participants |
| Zilver PTX Stent Implantation | Number of CEC-adjudicated Events Through 12 Months | Target Vessel Revascularization | 13 participants |
| Zilver PTX Stent Implantation | Number of CEC-adjudicated Events Through 12 Months | Target Limb Amputation | 2 participants |
| Long Lesion Substudy | Number of CEC-adjudicated Events Through 12 Months | Target Vessel Revascularization | 4 participants |
| Long Lesion Substudy | Number of CEC-adjudicated Events Through 12 Months | All deaths | 0 participants |
| Long Lesion Substudy | Number of CEC-adjudicated Events Through 12 Months | Stent Thrombosis | 0 participants |
| Long Lesion Substudy | Number of CEC-adjudicated Events Through 12 Months | Target Lesion Revascularization | 3 participants |
| Long Lesion Substudy | Number of CEC-adjudicated Events Through 12 Months | Target Limb Amputation | 0 participants |
| PK Substudy | Number of CEC-adjudicated Events Through 12 Months | Stent Thrombosis | 0 participants |
| PK Substudy | Number of CEC-adjudicated Events Through 12 Months | Target Lesion Revascularization | 1 participants |
| PK Substudy | Number of CEC-adjudicated Events Through 12 Months | Target Vessel Revascularization | 0 participants |
| PK Substudy | Number of CEC-adjudicated Events Through 12 Months | Target Limb Amputation | 0 participants |
| PK Substudy | Number of CEC-adjudicated Events Through 12 Months | All deaths | 0 participants |
Secondary
Number of Participants With Hemodynamic Improvement
Defined as an increase in the ankle-brachial index by greater than of equal to 0.10 compared with baseline or to an ankle-brachial index of greater than or equal to 0.90, without need for repeat target lesion revascularization.
Time frame: 12 Months
Population: Per PK sub-study design, secondary endpoint not analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ELUVIA Stent Implantation | Number of Participants With Hemodynamic Improvement | 223 Participants |
| Zilver PTX Stent Implantation | Number of Participants With Hemodynamic Improvement | 111 Participants |
| Long Lesion Substudy | Number of Participants With Hemodynamic Improvement | 37 Participants |
Secondary
Walking Impairment Questionnaire (WIQ) Scores
The WIQ 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. WIQ scores reported as change from baseline.
Time frame: Baseline to 12 Months
Population: Not all subjects were able to complete questionnaires.Per PK sub-study design, secondary endpoint not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ELUVIA Stent Implantation | Walking Impairment Questionnaire (WIQ) Scores | Speed | 18.25 Units on a scale | Standard Deviation 29.46 |
| ELUVIA Stent Implantation | Walking Impairment Questionnaire (WIQ) Scores | Distance | 33.16 Units on a scale | Standard Deviation 38.33 |
| ELUVIA Stent Implantation | Walking Impairment Questionnaire (WIQ) Scores | Stair climbing | 19.43 Units on a scale | Standard Deviation 36.68 |
| Zilver PTX Stent Implantation | Walking Impairment Questionnaire (WIQ) Scores | Speed | 18.08 Units on a scale | Standard Deviation 28.72 |
| Zilver PTX Stent Implantation | Walking Impairment Questionnaire (WIQ) Scores | Distance | 29.49 Units on a scale | Standard Deviation 38.19 |
| Zilver PTX Stent Implantation | Walking Impairment Questionnaire (WIQ) Scores | Stair climbing | 21.10 Units on a scale | Standard Deviation 34.55 |
| Long Lesion Substudy | Walking Impairment Questionnaire (WIQ) Scores | Distance | 58.67 Units on a scale | Standard Deviation 36.6 |
| Long Lesion Substudy | Walking Impairment Questionnaire (WIQ) Scores | Stair climbing | 56.29 Units on a scale | Standard Deviation 34.55 |
| Long Lesion Substudy | Walking Impairment Questionnaire (WIQ) Scores | Speed | 41.21 Units on a scale | Standard Deviation 25.95 |
Other Pre-specified
Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate
Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization rate
Time frame: Through 60 Months
Population: PK Substudy cohort was not included in this outcome
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ELUVIA Stent Implantation | Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate | 68 Participants |
| Zilver PTX Stent Implantation | Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate | 39 Participants |
| Long Lesion Substudy | Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate | 15 Participants |
| PK Substudy | Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate | 0 Participants |
Other Pre-specified
Freedom From Major Adverse Events
Percentage of participants without Major Adverse Events (MAEs)
Time frame: Through 60 Months
Population: PK Substudy cohort was not included in this outcome
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ELUVIA Stent Implantation | Freedom From Major Adverse Events | 156 Participants |
| Zilver PTX Stent Implantation | Freedom From Major Adverse Events | 74 Participants |
| Long Lesion Substudy | Freedom From Major Adverse Events | 19 Participants |
| PK Substudy | Freedom From Major Adverse Events | 0 Participants |
Other Pre-specified
Percentage of Participants With Target Limb Major Amputation
Clinical Events Committee (CEC) adjudicated target limb major amputation rate
Time frame: Through 60 Months
Population: PK Substudy cohort was not included in this outcome
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ELUVIA Stent Implantation | Percentage of Participants With Target Limb Major Amputation | 8 Participants |
| Zilver PTX Stent Implantation | Percentage of Participants With Target Limb Major Amputation | 3 Participants |
| Long Lesion Substudy | Percentage of Participants With Target Limb Major Amputation | 0 Participants |
| PK Substudy | Percentage of Participants With Target Limb Major Amputation | 0 Participants |