Arterial Occlusive Diseases, Arteriosclerosis, Atherosclerosis, Vascular Diseases
Conditions
Keywords
atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), stenting, paclitaxel
Brief summary
The EMINENT study is a prospective, multi-center study evaluating the effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries.
Detailed description
The EMINENT study is a prospective, multi-center study evaluating the effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions 30-210 mm long located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4. The study is a 2:1 randomized (ELUVIA vs Self-Expanding Bare Nitinol Stents), controlled, single-blind, superiority trial (RCT). The objective of the study is to evaluate the effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 210 mm in length when compared against bare metal stents, and collect additional data including health economics data.
Interventions
DEVICEPeripheral stenting
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 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 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 Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA): 1. Degree of stenosis ≥ 70 % by visual angiographic assessment 2. Vessel diameter ≥ 4 and ≤ 6 mm 3. Total lesion length (or series of lesions) ≥ 30 mm and ≤210 mm (Note: Lesion segment(s) must be fully covered with one or two overlapping ELUVIA stent(s) or Self Expanding Bare Nitinol stent(s)) 4. For occluded lesions (chronic occlusions) requiring use of re-entry device, lesion length ≤ 180 mm 5. 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 within 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 such as Rotarex 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 study, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical study 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 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 less than 80000 mm3 or more than 600000 mm3 or history of bleeding diathesis 10. Concomitant renal failure with a serum creatinine higher than 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 an 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 at the time of the index procedure 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 22. As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Primary Patency at 12 Months Post-procedure | 12 Months | The primary effectiveness endpoint assesses primary patency at 12 months post-procedure. This effectiveness endpoint is designed to demonstrate that the 12-month primary patency for the ELUVIA treatment group is superior to the Self-Expanding Bare Nitinol Stents treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Walking Improvement - Distance at Baseline to 12 Months | 12 Months | Walking Improvement will be assessed and compared between the 2 study arms, by evaluating the change in Six Minute Hall Walk (6MHW) / treadmill test from baseline, or preceding any Target Vessel Revascularization and evaluating change in Walking Impairment Questionnaire (WIQ) from baseline. Values are represented as a mean and standard deviation and reflect the change in meters walked. |
| Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month | 12 Months | The change in quality of life will be assessed and compared between the 2 study arms, by evaluating change in EuroQol (EQ) - 5 Dimensions (5D) - 5 Levels (5L) questionnaire (EQ-5D-5L™) from baseline, or preceding any Target Vessel Revascularization Values are presented as a count of subjects at 12-months and by the number of subjects analyzed. |
| Cost Effectiveness | during index procedure, 1, 6, 12, 24 and 36 months | Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol stents. |
| Number of Subjects With Clinical Improvement at 12-months | 12 months | Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline. Values are presented as a count of participants at 12-months by the number of participants analyzed. Rutherford Classification describes 7 categories of peripheral artery disease, including both the patient's clinical symptoms as well as objective findings; Primary sustained clinical improvement, is a rate of improvement in Rutherford classification of one or more categories as compared to baseline without the need for repeat target lesion revascularization (TLR); Secondary sustained clinical improvement is a rate of improvement in Rutherford classification of one or more categories as compared to baseline including those subjects with repeat TLR; Clinical deterioration, is the rate of downgrade in Rutherford classification of one or more categories as compared to baseline |
| Number of Subjects With Hemodynamic Improvement at 12-months | 12 months | Hemodynamic improvement was evaluated by assessing the number of participants that demonstrated an increase in the Ankle-Brachial Index value of \>/= 0.10 or an increase in the overall ABI value to \>/= 0.90 from baseline to 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinically-driven Target Lesion Revascularization (TLR) Rate | 1, 6, 12, 24, and 36 months | Target Lesion Revascularization, defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure, rate at each time point. |
| Clinically-driven Target Vessel Revascularization (TVR) Rate | 1, 6, 12, 24 and 36 months | Target Vessel Revascularization, defined as any surgical or percutaneous intervention to the target vessel after the index procedure, rate at each time point. |
| Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 1, 6, 12, 24, and 36 months | Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months assessed by change in Walking Impairment Questionnaire (WIQ) from baseline. |
| Procedural Success | within 24 hours of stenting procedure | Procedural success defined as technical success with no MAEs noted within 24 hours of the index procedure |
| Number of Stent Fractures | 12 Months | Number of Stent Fractures reported at 12 months utilizing the Vascular InterVentional Advances (VIVA) definitions assessed by an independent core laboratory. Stent fractures were analyzed if sites collected imaging per standard of care (SOC). |
| Technical Success | during index procedure after stent delivered and deployed to the target lesion | Technical success defined as delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually |
| Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 1, 6, 24, and 36 months | Quality of Life Improvement will be assessed at 1-month, 6-months, 24-months, and 36-months by evaluating the change in EQ-5D-5L™ from baseline |
| Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 1, 6, 24, and 36 months | Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline |
| Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 1, 6, 24, and 36 months | The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline |
| Primary Patency and Assisted Primary Patency | 6 and 12 months | Primary Patency and Assisted Primary Patency at 6 months, 12 months using different Duplex Ultrasound (DUS) and Peak Systolic Velocity Ration (PSVRs). All DUS readings will be assessed by an independent core laboratory. Primary Patency is reported at 6 and 12-months. |
| Adverse Event and Major Adverse Event (MAE) Rate | 1, 6, 12, 24, and 36 months | Adverse Event rate and Major Adverse Event rate, defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization, rate at each time point |
Countries
Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom
Participant flow
Pre-assignment details
Over an enrollment period of 41 months, 775 subjects were enrolled in the study of which, 508 subjects were enrolled in the investigational test device arm and 267 were enrolled in the bare metal stent (control device).
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. | 508 |
| Control Bare Metal Stent Implantation Percutaneous stent placement in the SFA/PPA of commercially available stents in Europe Permitted stents are Supera (Abbott), Lifestent (CR Bard), Everflex (Covidien/Medtronic), S.M.A.R.T. Flex (Cordis/Cardinal), S.M.A.R.T. Control (Cordis/Cardinal), Pulsar (Biotronik), COMPLETE SE (Medtronic), Misago (Terumo) or Innova (Boston Scientific) | 267 |
| Total | 775 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 12 | 3 |
| Overall Study | Early completion | 5 | 1 |
| Overall Study | Pending data entry | 1 | 0 |
| Overall Study | Protocol Violation | 17 | 6 |
| Overall Study | Withdrawal by Subject | 20 | 8 |
Baseline characteristics
| Characteristic | ELUVIA Stent Implantation | Control Bare Metal Stent Implantation | Total |
|---|---|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 8.7 | 68.9 years STANDARD_DEVIATION 9.1 | 68.9 years STANDARD_DEVIATION 8.8 |
| Current Anginal Status None | 482 Participants | 250 Participants | 732 Participants |
| Current Anginal Status Stable Angina | 19 Participants | 7 Participants | 26 Participants |
| Current Anginal Status Unknown | 7 Participants | 10 Participants | 17 Participants |
| Current Anginal Status Unstable Angina | 0 Participants | 0 Participants | 0 Participants |
| Current Diabetes Mellitus | 180 Participants | 96 Participants | 276 Participants |
| History of Cerebrovascular Accident (CVA) | 38 Participants | 15 Participants | 53 Participants |
| History of Chronic Obstructive Pulmonary Disease | 65 Participants | 33 Participants | 98 Participants |
| History of Claudication | 447 Participants | 228 Participants | 675 Participants |
| History of Congestive Heart Failure | 35 Participants | 13 Participants | 48 Participants |
| History of Coronary Artery Bypass Graft (CABG) Surgery | 50 Participants | 30 Participants | 80 Participants |
| History of Coronary Artery Disease | 159 Participants | 96 Participants | 255 Participants |
| History of Endovascular Interventions in Target Vessel | 36 Participants | 25 Participants | 61 Participants |
| History of Hyperlipidemia requiring medication | 341 Participants | 182 Participants | 523 Participants |
| History of Hypertension requiring medication | 397 Participants | 203 Participants | 600 Participants |
| History of Myocardial Infarction (MI) | 75 Participants | 41 Participants | 116 Participants |
| History of Other Peripheral Endovascular Interventions (other than Target Vessel) | 147 Participants | 86 Participants | 233 Participants |
| History of Percutaneous Coronary Intervention (PCI) | 114 Participants | 67 Participants | 181 Participants |
| History of Renal Insufficiency | 59 Participants | 22 Participants | 81 Participants |
| History of Renal Percutaneous Intervention | 6 Participants | 5 Participants | 11 Participants |
| History of Smoking Current | 183 Participants | 96 Participants | 279 Participants |
| History of Smoking Never | 91 Participants | 44 Participants | 135 Participants |
| History of Smoking Previous | 201 Participants | 111 Participants | 312 Participants |
| History of Smoking Unknown | 33 Participants | 16 Participants | 49 Participants |
| History of Transient Ischemic Attacks (TIA) | 29 Participants | 11 Participants | 40 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black of African Heritage | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 434 Participants | 234 Participants | 668 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Disclosed | 55 Participants | 21 Participants | 76 Participants |
| Race/Ethnicity, Customized Other | 16 Participants | 8 Participants | 24 Participants |
| Region of Enrollment Austria | 53 participants | 28 participants | 81 participants |
| Region of Enrollment Belgium | 71 participants | 40 participants | 111 participants |
| Region of Enrollment France | 73 participants | 34 participants | 107 participants |
| Region of Enrollment Germany | 206 participants | 106 participants | 312 participants |
| Region of Enrollment Ireland | 1 participants | 1 participants | 2 participants |
| Region of Enrollment Italy | 45 participants | 24 participants | 69 participants |
| Region of Enrollment Netherlands | 13 participants | 6 participants | 19 participants |
| Region of Enrollment Spain | 13 participants | 6 participants | 19 participants |
| Region of Enrollment Switzerland | 18 participants | 12 participants | 30 participants |
| Region of Enrollment United Kingdom | 15 participants | 10 participants | 25 participants |
| Sex: Female, Male Female | 145 Participants | 87 Participants | 232 Participants |
| Sex: Female, Male Male | 363 Participants | 180 Participants | 543 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 39 / 508 | 15 / 267 |
| other Total, other adverse events | 109 / 492 | 54 / 273 |
| serious Total, serious adverse events | 181 / 492 | 90 / 273 |
Outcome results
Primary
Number of Subjects With Primary Patency at 12 Months Post-procedure
The primary effectiveness endpoint assesses primary patency at 12 months post-procedure. This effectiveness endpoint is designed to demonstrate that the 12-month primary patency for the ELUVIA treatment group is superior to the Self-Expanding Bare Nitinol Stents treatment group.
Time frame: 12 Months
Population: Primary patency defined as core-lab assessed duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.4 at 12 months in the absence of clinically-driven Target Lesion Revascularization (TLR) or bypass of the target lesion.~405/508 subjects in Eluvia and 222/267 subjects in the control arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ELUVIA Stent Implantation | Number of Subjects With Primary Patency at 12 Months Post-procedure | 337 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Primary Patency at 12 Months Post-procedure | 165 Participants |
p-value: 0.0077Chi-squared
Secondary
Cost Effectiveness
Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol stents.
Time frame: during index procedure, 1, 6, 12, 24 and 36 months
Population: Cost effectiveness was not collected for the study as this data was an optional health economics data analysis.
Secondary
Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month
The change in quality of life will be assessed and compared between the 2 study arms, by evaluating change in EuroQol (EQ) - 5 Dimensions (5D) - 5 Levels (5L) questionnaire (EQ-5D-5L™) from baseline, or preceding any Target Vessel Revascularization Values are presented as a count of subjects at 12-months and by the number of subjects analyzed.
Time frame: 12 Months
Population: The number analyzed for each row is based on the number of subjects that completed the portion of the quality-of-life assessment during the visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELUVIA Stent Implantation | Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month | Self-Care Improvement | 39 Participants |
| ELUVIA Stent Implantation | Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month | Pain/ Discomfort Improvement | 238 Participants |
| ELUVIA Stent Implantation | Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month | Usual Activities Improvement | 169 Participants |
| ELUVIA Stent Implantation | Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month | Anxiety/ Depression Improvement | 100 Participants |
| ELUVIA Stent Implantation | Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month | Mobility Improvement | 295 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month | Anxiety/ Depression Improvement | 49 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month | Mobility Improvement | 158 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month | Self-Care Improvement | 19 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month | Usual Activities Improvement | 91 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month | Pain/ Discomfort Improvement | 143 Participants |
Secondary
Number of Subjects Walking Improvement - Distance at Baseline to 12 Months
Walking Improvement will be assessed and compared between the 2 study arms, by evaluating the change in Six Minute Hall Walk (6MHW) / treadmill test from baseline, or preceding any Target Vessel Revascularization and evaluating change in Walking Impairment Questionnaire (WIQ) from baseline. Values are represented as a mean and standard deviation and reflect the change in meters walked.
Time frame: 12 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ELUVIA Stent Implantation | Number of Subjects Walking Improvement - Distance at Baseline to 12 Months | Baseline | 258.4 Meter | Standard Deviation 153.4 |
| ELUVIA Stent Implantation | Number of Subjects Walking Improvement - Distance at Baseline to 12 Months | 12 Month | 392.4 Meter | Standard Deviation 286 |
| Control Bare Metal Stent Implantation | Number of Subjects Walking Improvement - Distance at Baseline to 12 Months | Baseline | 239.1 Meter | Standard Deviation 150 |
| Control Bare Metal Stent Implantation | Number of Subjects Walking Improvement - Distance at Baseline to 12 Months | 12 Month | 361.9 Meter | Standard Deviation 176.2 |
Secondary
Number of Subjects With Clinical Improvement at 12-months
Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline. Values are presented as a count of participants at 12-months by the number of participants analyzed. Rutherford Classification describes 7 categories of peripheral artery disease, including both the patient's clinical symptoms as well as objective findings; Primary sustained clinical improvement, is a rate of improvement in Rutherford classification of one or more categories as compared to baseline without the need for repeat target lesion revascularization (TLR); Secondary sustained clinical improvement is a rate of improvement in Rutherford classification of one or more categories as compared to baseline including those subjects with repeat TLR; Clinical deterioration, is the rate of downgrade in Rutherford classification of one or more categories as compared to baseline
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 12-months | Primary Sustained Clinical Improvement - Improvement in Rutherford Classification without TLR | 365 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 12-months | No Change from Baseline | 40 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 12-months | Clinical Deterioration | 4 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 12-months | Secondary Sustained Clinical Improvement - Improvement in Rutherford Classification with TLR | 396 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 12-months | Clinical Deterioration | 3 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 12-months | Primary Sustained Clinical Improvement - Improvement in Rutherford Classification without TLR | 187 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 12-months | Secondary Sustained Clinical Improvement - Improvement in Rutherford Classification with TLR | 211 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 12-months | No Change from Baseline | 30 Participants |
Secondary
Number of Subjects With Hemodynamic Improvement at 12-months
Hemodynamic improvement was evaluated by assessing the number of participants that demonstrated an increase in the Ankle-Brachial Index value of \>/= 0.10 or an increase in the overall ABI value to \>/= 0.90 from baseline to 12 months
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELUVIA Stent Implantation | Number of Subjects With Hemodynamic Improvement at 12-months | Hemodynamic Improvement | 331 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Hemodynamic Improvement at 12-months | Hemodynamic Improvement - Including TLR | 355 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Hemodynamic Improvement at 12-months | Hemodynamic Improvement | 179 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Hemodynamic Improvement at 12-months | Hemodynamic Improvement - Including TLR | 196 Participants |
Other Pre-specified
Adverse Event and Major Adverse Event (MAE) Rate
Adverse Event rate and Major Adverse Event rate, defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization, rate at each time point
Time frame: 1, 6, 12, 24, and 36 months
Population: The number Started in Participant Flow indicates the intent-to-treat population while the number analyzed indicates the as-treated (AT) population. For AT analysis, subjects implanted are included based on the actual Test or Control device each subject received (including cross-over subjects). Only study permitted stents are included in the AT set.~The number analyzed in the data table differs from the overall analyzed as it indicates subjects that reached the lower limit for the visit window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 1 Month Adverse Event Rate | 77 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 6 Month Adverse Event Rate | 105 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 12 Month Adverse Event Rate | 134 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 24 Month Adverse Event Rate | 181 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 36 Month Adverse Event Rate | 215 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 1 Month - MAE - All Cause Death | 3 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 1 Month - MAE - Target Limb Major Amputation | 1 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 1 Month - MAE - Target Lesion Revascularization | 2 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 6 Month - MAE - All Cause Death | 7 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 6 Month - MAE - Target Limb Major Amputation | 1 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 6 Month - MAE - Target Lesion Revascularization | 23 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 12 Month - MAE - All Cause Death | 13 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 12 Month - MAE - Target Limb Major Amputation | 1 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 12 Month - MAE - Target Lesion Revascularization | 42 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 24 Month - MAE - All Cause Death | 28 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 24 Month - MAE - Target Limb Major Amputation | 1 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 24 Month - MAE - Target Lesion Revascularization | 71 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 36 Month - MAE - All Cause Death | 38 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 36 Month - MAE - Target Limb Major Amputation | 2 Participants |
| ELUVIA Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 36 Month - MAE - Target Lesion Revascularization | 100 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 36 Month - MAE - All Cause Death | 15 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 1 Month Adverse Event Rate | 32 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 6 Month - MAE - Target Lesion Revascularization | 7 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 6 Month Adverse Event Rate | 54 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 24 Month - MAE - Target Limb Major Amputation | 0 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 12 Month Adverse Event Rate | 79 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 12 Month - MAE - All Cause Death | 3 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 24 Month Adverse Event Rate | 96 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 36 Month - MAE - Target Lesion Revascularization | 53 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 36 Month Adverse Event Rate | 111 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 12 Month - MAE - Target Limb Major Amputation | 0 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 1 Month - MAE - All Cause Death | 0 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 24 Month - MAE - Target Lesion Revascularization | 45 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 1 Month - MAE - Target Limb Major Amputation | 0 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 12 Month - MAE - Target Lesion Revascularization | 28 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 1 Month - MAE - Target Lesion Revascularization | 2 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 36 Month - MAE - Target Limb Major Amputation | 1 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 6 Month - MAE - All Cause Death | 3 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 24 Month - MAE - All Cause Death | 8 Participants |
| Control Bare Metal Stent Implantation | Adverse Event and Major Adverse Event (MAE) Rate | 6 Month - MAE - Target Limb Major Amputation | 0 Participants |
Other Pre-specified
Clinically-driven Target Lesion Revascularization (TLR) Rate
Target Lesion Revascularization, defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure, rate at each time point.
Time frame: 1, 6, 12, 24, and 36 months
Population: The number started in participant flow indicates the intent-to-treat population while the number analyzed indicates the the as-treated population.~For as-treated analysis, all subjects in the per-protocol population will be included based on the actual Test or Control device that each subject received (i.e. including cross-over subjects).~The number analyzed in the rows below differs from the overall analyzed as it indicates the subjects that reached the lower limit for the visit window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELUVIA Stent Implantation | Clinically-driven Target Lesion Revascularization (TLR) Rate | 6 Month - Clinically-driven TLR | 23 Participants |
| ELUVIA Stent Implantation | Clinically-driven Target Lesion Revascularization (TLR) Rate | 24 Month - Clinically-driven TLR | 69 Participants |
| ELUVIA Stent Implantation | Clinically-driven Target Lesion Revascularization (TLR) Rate | 12 Month - Clinically-driven TLR | 40 Participants |
| ELUVIA Stent Implantation | Clinically-driven Target Lesion Revascularization (TLR) Rate | 36 Month - Clinically-driven TLR | 97 Participants |
| ELUVIA Stent Implantation | Clinically-driven Target Lesion Revascularization (TLR) Rate | 1 Month - Clinically-driven TLR | 3 Participants |
| Control Bare Metal Stent Implantation | Clinically-driven Target Lesion Revascularization (TLR) Rate | 36 Month - Clinically-driven TLR | 53 Participants |
| Control Bare Metal Stent Implantation | Clinically-driven Target Lesion Revascularization (TLR) Rate | 1 Month - Clinically-driven TLR | 2 Participants |
| Control Bare Metal Stent Implantation | Clinically-driven Target Lesion Revascularization (TLR) Rate | 6 Month - Clinically-driven TLR | 7 Participants |
| Control Bare Metal Stent Implantation | Clinically-driven Target Lesion Revascularization (TLR) Rate | 12 Month - Clinically-driven TLR | 28 Participants |
| Control Bare Metal Stent Implantation | Clinically-driven Target Lesion Revascularization (TLR) Rate | 24 Month - Clinically-driven TLR | 45 Participants |
Other Pre-specified
Clinically-driven Target Vessel Revascularization (TVR) Rate
Target Vessel Revascularization, defined as any surgical or percutaneous intervention to the target vessel after the index procedure, rate at each time point.
Time frame: 1, 6, 12, 24 and 36 months
Population: The number analyzed indicates the subjects that reached the lower limit for the visit window.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELUVIA Stent Implantation | Clinically-driven Target Vessel Revascularization (TVR) Rate | 36 Month - Clinically-driven TVR | 105 Participants |
| ELUVIA Stent Implantation | Clinically-driven Target Vessel Revascularization (TVR) Rate | 1 Month - Clinically-driven TVR | 4 Participants |
| ELUVIA Stent Implantation | Clinically-driven Target Vessel Revascularization (TVR) Rate | 6 Month - Clinically-driven TVR | 26 Participants |
| ELUVIA Stent Implantation | Clinically-driven Target Vessel Revascularization (TVR) Rate | 12 Month - Clinically-driven TVR | 52 Participants |
| ELUVIA Stent Implantation | Clinically-driven Target Vessel Revascularization (TVR) Rate | 24 Month - Clinically-driven TVR | 77 Participants |
| Control Bare Metal Stent Implantation | Clinically-driven Target Vessel Revascularization (TVR) Rate | 24 Month - Clinically-driven TVR | 48 Participants |
| Control Bare Metal Stent Implantation | Clinically-driven Target Vessel Revascularization (TVR) Rate | 12 Month - Clinically-driven TVR | 30 Participants |
| Control Bare Metal Stent Implantation | Clinically-driven Target Vessel Revascularization (TVR) Rate | 1 Month - Clinically-driven TVR | 4 Participants |
| Control Bare Metal Stent Implantation | Clinically-driven Target Vessel Revascularization (TVR) Rate | 36 Month - Clinically-driven TVR | 56 Participants |
| Control Bare Metal Stent Implantation | Clinically-driven Target Vessel Revascularization (TVR) Rate | 6 Month - Clinically-driven TVR | 10 Participants |
Other Pre-specified
Number of Stent Fractures
Number of Stent Fractures reported at 12 months utilizing the Vascular InterVentional Advances (VIVA) definitions assessed by an independent core laboratory. Stent fractures were analyzed if sites collected imaging per standard of care (SOC).
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| ELUVIA Stent Implantation | Number of Stent Fractures | 1 Stents |
| Control Bare Metal Stent Implantation | Number of Stent Fractures | 2 Stents |
Other Pre-specified
Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline
Time frame: 1, 6, 24, and 36 months
Population: The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Primary Sustained Clinical Improvement | 328 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Secondary Sustained Clinical Improvement | 329 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - No Change from Baseline | 22 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Clinical Deterioration | 3 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Primary Sustained Clinical Improvement | 403 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Secondary Sustained Clinical Improvement | 415 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - No Change from Baseline | 35 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Clinical Deterioration | 5 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Primary Sustained Clinical Improvement | 304 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Secondary Sustained Clinical Improvement | 356 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - No Change from Baseline | 35 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Clinical Deterioration | 8 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Primary Sustained Clinical Improvement | 263 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Secondary Sustained Clinical Improvement | 336 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - No Change from Baseline | 35 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Clinical Deterioration | 8 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Clinical Deterioration | 6 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Primary Sustained Clinical Improvement | 175 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Primary Sustained Clinical Improvement | 170 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Secondary Sustained Clinical Improvement | 176 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Primary Sustained Clinical Improvement | 152 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - No Change from Baseline | 13 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Secondary Sustained Clinical Improvement | 201 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Clinical Deterioration | 1 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - No Change from Baseline | 22 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Primary Sustained Clinical Improvement | 223 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - No Change from Baseline | 24 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Secondary Sustained Clinical Improvement | 227 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Secondary Sustained Clinical Improvement | 188 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - No Change from Baseline | 17 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Clinical Deterioration | 1 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Clinical Deterioration | 4 Participants |
Other Pre-specified
Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months
The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline
Time frame: 1, 6, 24, and 36 months
Population: The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELUVIA Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Hemodynamic Improvement | 287 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Hemodynamic Improvement (Including TLR) | 288 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Hemodynamic Improvement | 355 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Hemodynamic Improvement (Including TLR) | 366 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Hemodynamic Improvement | 248 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Hemodynamic Improvement (Including TLR) | 293 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Hemodynamic Improvement | 215 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Hemodynamic Improvement (Including TLR) | 272 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Hemodynamic Improvement (Including TLR) | 154 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Hemodynamic Improvement | 163 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Hemodynamic Improvement | 145 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Hemodynamic Improvement (Including TLR) | 164 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Hemodynamic Improvement | 123 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Hemodynamic Improvement | 196 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Hemodynamic Improvement (Including TLR) | 166 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Hemodynamic Improvement (Including TLR) | 200 Participants |
Other Pre-specified
Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
Quality of Life Improvement will be assessed at 1-month, 6-months, 24-months, and 36-months by evaluating the change in EQ-5D-5L™ from baseline
Time frame: 1, 6, 24, and 36 months
Population: The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Mobility Improvement | 269 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Mobility Improvement | 307 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Self Care Improvement | 32 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Mobility Improvement | 257 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Usual Activities Improvement | 149 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Self Care Improvement | 41 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Pain/ Discomfort Improvement | 211 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Pain/ Discomfort Improvement | 217 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Anxiety/ Depression Improvement | 89 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Usual Activities Improvement | 168 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Mobility Improvement | 238 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Self Care Improvement | 30 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Self Care Improvement | 30 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Pain/ Discomfort Improvement | 258 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Usual Activities Improvement | 136 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Anxiety/ Depression Improvement | 70 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Pain/ Discomfort Improvement | 191 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Anxiety/ Depression Improvement | 86 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Anxiety/ Depression Improvement | 76 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Usual Activities Improvement | 130 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Anxiety/ Depression Improvement | 42 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Mobility Improvement | 137 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Usual Activities Improvement | 76 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Pain/ Discomfort Improvement | 120 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Anxiety/ Depression Improvement | 35 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Mobility Improvement | 162 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Self Care Improvement | 18 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Usual Activities Improvement | 95 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Pain/ Discomfort Improvement | 142 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 6 Month - Anxiety/ Depression Improvement | 53 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Mobility Improvement | 148 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Self Care Improvement | 18 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Usual Activities Improvement | 86 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Pain/ Discomfort Improvement | 137 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 24 Month - Anxiety/ Depression Improvement | 51 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Mobility Improvement | 136 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Self Care Improvement | 15 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Usual Activities Improvement | 78 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 36 Month - Pain/ Discomfort Improvement | 104 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months | 1 Month - Self Care Improvement | 11 Participants |
Other Pre-specified
Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months assessed by change in Walking Impairment Questionnaire (WIQ) from baseline.
Time frame: 1, 6, 12, 24, and 36 months
Population: The number analyzed for each row is based on the number of subjects that completed the assessment during the specified visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 1 Month - PAD Specific Question - Number of Subjects Improved | 297 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 1 Month - Distance Score - Number of Subjects Improved | 299 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 1 Month - Speed Scores - Number of Subjects Improved | 270 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 1 Month - Stair Climbing Scores - Number of Subjects Improved | 238 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 6 Month - PAD Specific Question - Number of Subjects Improved | 366 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 6 Month - Distance Score - Number of Subjects Improved | 381 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 6 Month - Speed Scores - Number of Subjects Improved | 335 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 6 Month - Stair Climbing Scores - Number of Subjects Improved | 309 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 12 Month - PAD Specific Question - Number of Subjects Improved | 360 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 12 Month - Distance Score - Number of Subjects Improved | 372 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 12 Month - Speed Scores - Number of Subjects Improved | 321 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 12 Month - Stair Climbing Scores - Number of Subjects Improved | 300 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 24 Month - PAD Specific Question - Number of Subjects Improved | 317 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 24 Month - Distance Score - Number of Subjects Improved | 344 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 24 Month - Speed Scores - Number of Subjects Improved | 289 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 24 Month - Stair Climbing Scores - Number of Subjects Improved | 269 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 36 Month - PAD Specific Question - Number of Subjects Improved | 298 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 36 Month - Distance Score - Number of Subjects Improved | 304 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 36 Month - Speed Scores - Number of Subjects Improved | 256 Participants |
| ELUVIA Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 36 Month - Stair Climbing Scores - Number of Subjects Improved | 243 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 36 Month - Distance Score - Number of Subjects Improved | 178 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 1 Month - PAD Specific Question - Number of Subjects Improved | 158 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 12 Month - Speed Scores - Number of Subjects Improved | 173 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 1 Month - Distance Score - Number of Subjects Improved | 162 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 24 Month - Stair Climbing Scores - Number of Subjects Improved | 143 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 1 Month - Speed Scores - Number of Subjects Improved | 140 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 12 Month - Stair Climbing Scores - Number of Subjects Improved | 159 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 1 Month - Stair Climbing Scores - Number of Subjects Improved | 133 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 36 Month - Stair Climbing Scores - Number of Subjects Improved | 123 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 6 Month - PAD Specific Question - Number of Subjects Improved | 195 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 24 Month - PAD Specific Question - Number of Subjects Improved | 170 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 6 Month - Distance Score - Number of Subjects Improved | 216 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 36 Month - PAD Specific Question - Number of Subjects Improved | 164 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 6 Month - Speed Scores - Number of Subjects Improved | 180 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 24 Month - Distance Score - Number of Subjects Improved | 188 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 6 Month - Stair Climbing Scores - Number of Subjects Improved | 164 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 36 Month - Speed Scores - Number of Subjects Improved | 135 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 12 Month - PAD Specific Question - Number of Subjects Improved | 184 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 24 Month - Speed Scores - Number of Subjects Improved | 149 Participants |
| Control Bare Metal Stent Implantation | Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months | 12 Month - Distance Score - Number of Subjects Improved | 204 Participants |
Other Pre-specified
Primary Patency and Assisted Primary Patency
Primary Patency and Assisted Primary Patency at 6 months, 12 months using different Duplex Ultrasound (DUS) and Peak Systolic Velocity Ration (PSVRs). All DUS readings will be assessed by an independent core laboratory. Primary Patency is reported at 6 and 12-months.
Time frame: 6 and 12 months
Population: The number analyzed indicates the subjects with available diagnostic duplex ultrasound images.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ELUVIA Stent Implantation | Primary Patency and Assisted Primary Patency | 6 Month - Primary Patency | 395 Participants |
| ELUVIA Stent Implantation | Primary Patency and Assisted Primary Patency | 6 Month - Assisted Primary Patency | 409 Participants |
| ELUVIA Stent Implantation | Primary Patency and Assisted Primary Patency | 12 Month - Primary Patency | 337 Participants |
| ELUVIA Stent Implantation | Primary Patency and Assisted Primary Patency | 12 Month - Assisted Primary Patency | 360 Participants |
| Control Bare Metal Stent Implantation | Primary Patency and Assisted Primary Patency | 12 Month - Assisted Primary Patency | 182 Participants |
| Control Bare Metal Stent Implantation | Primary Patency and Assisted Primary Patency | 6 Month - Primary Patency | 195 Participants |
| Control Bare Metal Stent Implantation | Primary Patency and Assisted Primary Patency | 12 Month - Primary Patency | 165 Participants |
| Control Bare Metal Stent Implantation | Primary Patency and Assisted Primary Patency | 6 Month - Assisted Primary Patency | 200 Participants |
Other Pre-specified
Procedural Success
Procedural success defined as technical success with no MAEs noted within 24 hours of the index procedure
Time frame: within 24 hours of stenting procedure
Population: The number started in participant flow indicates the intent-to-treat population while the number analyzed indicates the the as-treated population.~For as-treated analysis, all subjects in the per-protocol population will be included based on the actual Test or Control device that each subject received (i.e. including cross-over subjects).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ELUVIA Stent Implantation | Procedural Success | 488 Participants |
| Control Bare Metal Stent Implantation | Procedural Success | 269 Participants |
Other Pre-specified
Technical Success
Technical success defined as delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually
Time frame: during index procedure after stent delivered and deployed to the target lesion
Population: The number started in participant flow indicates the intent-to-treat population while the number analyzed indicates the the as-treated population.~For as-treated analysis, all subjects in the per-protocol population will be included based on the actual Test or Control device that each subject received (i.e. including cross-over subjects).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ELUVIA Stent Implantation | Technical Success | 488 Participants |
| Control Bare Metal Stent Implantation | Technical Success | 269 Participants |