Artery Diseases, Peripheral, Atherosclerosis, Occlusive Arterial Disease, Peripheral Artery Disease, Plaque, Atherosclerotic
Conditions
Keywords
Artery, Atherosclerosis, Arterial, Peripheral, Plaque, Angioplasty, PTA
Brief summary
To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA). Long Balloon substudy: To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Ranger™ Paclitaxel Coated Balloon in the 120, 150 and 200 mm lengths for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
Detailed description
The RANGER II SFA is a global, prospective, multi-center clinical trial. Approximately 446 subjects will be enrolled at up to 80 study centers worldwide. Regions participating include the United States, Canada, European Union, Japan and New Zealand. The trial consists of a single-blind, superiority, 3:1 (Ranger Drug-Coated Balloon (DCB) vs. Standard PTA) randomized controlled trial (RCT) and a concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy, and a concurrent, non-blinded, non-randomized, Long balloon substudy.
Interventions
DEVICERANGER™ Paclitaxel Coated Balloon
A procedure that utilizes a balloon coated with paclitaxel (drug) which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.
DRUGPaclitaxel
The RANGER™ Balloon is coated with the drug Paclitaxel.
PROCEDUREStandard Balloon Angioplasty
A procedure that utilizes an uncoated balloon which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will be blinded to treatment assigned and treatment received until completion of all 12 month follow-up visits (primary endpoint).
Intervention model description
The RANGER™ investigational device is coated with the drug paclitaxel.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits; 2. Subject at least 20 years of age; 3. Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4; 4. Target lesion is in the native SFA and/or PPA down to the P1 segment; 5. Patent popliteal and infrapopliteal arteries, i.e., single vessel runoff or better with at least one of three vessels patent (less than 50 % stenosis) to the ankle or foot; 6. Reference vessel diameter ≥ 4 mm and ≤ 8 mm by visual estimate; 7. Angiographic evidence that target lesion consists of a single de novo, non-stented and non-atherectomy treated or restenotic lesion (or tandem lesions or a combination lesion as defined below) that is: * ≥ 70%-99% stenotic with total lesion length up to 180 mm by visual estimate. * Occluded with total lesion length ≤ 100 mm by visual estimate. * If lesion is restenotic, most recent PTA treatment must be \> 3 months prior to enrollment.
Exclusion criteria
1. Life expectancy, documented in the Investigator's opinion, of less than 12 months; 2. Hemorrhagic stroke or cardiac event (e.g. STEMI, unstable angina) within 6 months prior to enrollment; 3. Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel; 4. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated; 5. Chronic renal insufficiency with serum creatinine \> 2.0 mg/dL within 30 days of index procedure or treatment with dialysis; 6. Platelet count \< 80,000 mm 3 or \> 600,000 mm 3 or history of bleeding diathesis; 7. Receiving immunosuppressive therapy; 8. Septicemia at the time of enrollment; 9. Any major intervention planned within 30 days post index procedure; 10. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of enrollment; 11. Failure to successfully cross the target lesion with a guidewire; 12. Failure to successfully pre-dilate the target vessel; 13. Patient has lesion that requires the use of adjunctive primary treatment modalities (i.e. laser, atherectomy, scoring/cutting balloon, other debulking devices, etc.) during the index procedure; 14. History of major amputation in the target limb; 15. Target lesion or vessel has ever been previously treated with stent (e.g. in-stent restenosis) or surgery. Target lesion or vessel has been treated with atherectomy or a DCB in the past 12 months; 16. Pregnant or breast feeding; 17. Presence of aneurysm in the target vessel; 18. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment; 19. Patient has significant inflow disease which cannot be treated prior to the target lesion treatment; 20. Patient has perforated targeted vessel as evidenced by extravasation of contrast media; 21. Patient has severe calcification that renders the lesion undilatable; 22. Current participation in another investigational drug or device clinical trial that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current trial endpoints.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Primary Lesion Patency | 12 months (RCT); 6 months (LB substudy) | RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR \>2.4 suggests \>50% stenosis. LB Substudy outcome measure: Primary patency of the target lesion is determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤ 2.4 in absence of clinically-driven TLR. Primary effectiveness endpoint is assessed at 6 months post-procedure. PK Substudy: There was no prespecified analysis of primary lesion patency. |
| Major Adverse Events (MAEs) (Primary Safety Endpoint) | Primary safety endpoint assessed at 12 months for RCT study and at both 6 and 12 months for LB substudy. | RCT: MAE is defined as a composite of freedom from all-cause death through 1 month, target limb major amputation (defined as at or above the ankle) within 12 months, and/or Target Lesion Revascularization (TLR) within 12 months. LB Substudy: Primary safety endpoint assesses the occurrence of MAE defined as all-cause death through 1 month, target limb major amputation and/or TLR at 6 and 12 months post-index procedure. PK Substudy: There was no prespecified analysis of primary safety endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Success Rate Assessment | Day 0 | Clinical success defined as procedural success without procedural complications including death, major target limb amputation, thrombosis of the target lesion, or clinically-driven TLR prior to discharge. |
| Number of Major Adverse Event (MAE) Assessment | 60-months (RCT); 12-months (LB substudy). | MAEs defined as all-cause of death post-index procedure (30-days), target limb major amputation, and/or target lesion revascularization (TLR) through 60-months in RCT. MAEs defined as all-cause of death post-index procedure (30-days), target limb major amputation, and/or target lesion revascularization (TLR) through 12-months in LB substudy. PK Substudy: There was no prespecified analysis of MAEs for PK substudy. |
| Number of Clinical Events Committee (CEC) Adjudicated Events | 1, 6, 12, 24, 36, 48 and 60 months (RCT and PK substudy); 1, 6 and 12 months (LB substudy) | CEC adjudicated events including death of any cause, target lesion revascularization (TLR), target vessel revascularization (TVR) and target limb amputation (TLA). Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reaches (or is beyond) the earliest visit window. LB substudy follow-up through 12 month. |
| Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 1, 6, 12, 24 and 36 months post-procedure (RCT); 1, 6 and 12 months post-procedure (LB substudy). | Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure without the need for repeat TLR. LB Substudy: Follow-up through 12-month. PK Substudy: There was no prespecified analysis of Rate of Primary Sustained Clinical Improvement for PK substudy. |
| Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 1, 6, 12, 24 and 36 months post-procedure (RCT): 1, 6, and 12 months post-procedure (LB substudy) | Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR. LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Secondary Sustained Clinical Improvement for PK substudy. |
| Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 1, 6, 12, 24, and 36 months post-procedure (RCT); 1, 6, and 12 months post-procedure (LB substudy) | Improvement of ABI by ≥ 0.1 or to an ABI ≥ 0.90 as compared to the pre-procedure value without the need for repeat revascularization. LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Hemodynamic Improvement for PK substudy. |
| Walking Improvement (Distance) at 6 and 12 Months as Assessed by Change in Six Minute Walk Test (6MWT) From Baseline | 6 and 12 months post-procedure (RCT) | The 6MWT measure the maximal walking distance that a patient achieves on a flat, hard surface within a period of 6 minutes. It evaluates the global and integrated responses of all physiological systems involved during exercise including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, neuromuscular units and muscle metabolism. Change in distance walked from baseline to 12 months. LB Substudy: There was no prespecified analysis of Walking Improvement (distance) for the LB substudy. PK Substudy: There was no prespecified analysis of Walking Improvement (distance) for PK substudy. |
| Number of Participants With Technical Success of Angioplasty Procedure | Day 0 | Technical success defined as successful delivery, balloon inflation and deflation and retrieval of the intact trial device without burst below the rated burst pressure. RCT Standard Balloon Angioplasty: Device deficiency data is only collected for Ranger DCB; data not collected for Standard PTA group; there is no pre-specified analysis of this outcome for the Standard PTA group. |
| Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 1, 6, 12, 24, and 36-months post-procedure (RCT); 1, 6, and 12-months post-procedure (LB substudy) | Duplex-defined binary restenosis (PSVR \> 2.4) of the target lesion at 1, 6, 12, 24 and 36 Months (RCT) Duplex-defined binary restenosis (PSVR \> 2.4) of the target lesion at 1, 6, and 12 (LB Substudy) PK Substudy: There was no prespecified analysis of duplex defined binary restenosis of the target lesion |
| Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 1, 6, 12, 24 and 36-months post-procedure (RCT). | Patient Utility Values as assessed by change in EQ-5D from baseline at 1, 6, 12, 24 and 36-months post-procedure. The EuroQOL (EQ)-5D is a multi-attribute health classification system. The EQ-5D uses a 5-dimension (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) descriptive system, which each consisting of 5 response options (no problems, slight problems, moderate problems, severe problems, or extreme problems/inability to perform). Outcomes reported as Improvement defined as improving at least one category from baseline. LB Substudy: There was no prespecified analysis of Patient Utility Values for the LB Substudy. PK Substudy: There was no prespecified analysis of Patient Utility Values for the PK Substudy. |
| Changes in Healthcare Utilization Over Time | 1, 6, 12, 24, 36, 48 and 60-months post-procedure (RCT); 1, 6, 12-months post-procedure (LB substudy) | Changes in healthcare utilization over time as measured by hospitalization readmission. Readmission Rate represents (# of subjects/Total enrolled subjects) who were hospitalized due to TLR/TVR or due to Procedure/Device related AE. LB Substudy: Follow-up through 12 Month. PK Substudy: There was no prespecified analysis of healthcare utilization over time for the PK Substudy. |
| PK Parameters Paclitaxel (PTx) Dose | Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure. | Summary of Pharmacokinetic Parameters in PK substudy. Paclitaxel (PTx) Dose PK parameter data not collected or analyzed in RCT or LB substudy. |
| PK Parameters - Maximum Plasma Concentration | Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure. | Summary of Pharmacokinetic Parameters in PK substudy. cmax (ng/mL) = Maximum plasma concentration PK data not collected or analyzed in RCT or LB substudy. |
| PK Parameters - Tmax | Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure. | Summary of Pharmacokinetic Parameters in PK substudy. - Tmax Tmax (h) = The timepoint where cmax is reached PK parameter data not collected or analyzed in RCT or LB substudy. |
| PK Parameters - Area Under the Blood Concentration Versus Time Curve From Time Zero up to the Time of the Last Quantifiable Concentration, Calculated by Trapezoidal Methods. | Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure. | Summary of Pharmacokinetic Parameters in PK substudy. AUC0-t (ng\*h/mL) = Area under the blood concentration versus time curve from time zero up to the time of the last quantifiable concentration, calculated by trapezoidal methods. PK parameter data not collected or analyzed in RCT or LB substudy. |
| Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline. | 1, 6, 12, 24 and 36 months post-procedure (RCT) | The WIQ is a functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability. It also assesses the reasons that walking ability might be limited. Range of scores include 0% (worst score) to 100% (best score). Walking improvement change assessed from baseline. LB Substudy: There was no prespecified analysis of Walking Improvement for the LB substudy. PK Substudy: There was no prespecified analysis of Walking Improvement for the PK substudy. |
| Number of Participants With Procedural Success of Angioplasty Procedure | Day 0 | Procedural success defined as residual stenosis of less than or equal to 50% (non-stented subjects) or less than or equal to 30% (stented subjects) by core laboratory evaluation. |
Countries
Austria, Belgium, Canada, Japan, New Zealand, United States
Participant flow
Pre-assignment details
A total of 440 subjects were enrolled in the trial (376 subjects in the Randomized Controlled Trial (RCT), 52 subjects in the Long Balloon (LB) substudy and 12 subjects in the Pharmacokinetic (PK) substudy). RCT subjects were randomized to Ranger Drug-Coated Balloon (DCB) or Standard Percutaneous Transluminal Angioplasty (PTA) at a 3:1 ratio, respectively. All LB and PK subjects were treated with the Ranger DCB. RCT/PK shows 60 months data; LB shows 12 month data.
Participants by arm
| Arm | Count |
|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. | 278 |
| Standard Balloon Angioplasty RCT Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. | 98 |
| Long Balloon (LB) Substudy The Long Balloon substudy cohort will evaluate the safety and effectiveness of the Ranger DCB in the 120, 150 and 200 mm lengths for treating SFA and/or PPA lesions. | 52 |
| Pharmacokinetics (PK) Substudy The PK substudy cohort will evaluate the safety and pharmacokinetics of the levels of paclitaxel in the systemic circulation of subjects at multiple time points after treatment with the Ranger DCB. Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure. | 12 |
| Total | 440 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 | 0 |
| Overall Study | Death | 40 | 16 | 4 | 2 |
| Overall Study | Lost to Follow-up | 7 | 3 | 0 | 0 |
| Overall Study | Missed Visit | 3 | 1 | 0 | 0 |
| Overall Study | Other reason for early termination | 3 | 2 | 0 | 0 |
| Overall Study | Physician Decision | 3 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 17 | 9 | 0 | 2 |
Baseline characteristics
| Characteristic | Total | RANGER™ Paclitaxel Coated Balloon RCT | Pharmacokinetics (PK) Substudy | Long Balloon (LB) Substudy | Standard Balloon Angioplasty RCT |
|---|---|---|---|---|---|
| Age, Continuous | 70.06 Years STANDARD_DEVIATION 9.87 | 70.6 Years STANDARD_DEVIATION 9.5 | 63.3 Years STANDARD_DEVIATION 13.3 | 70.3 Years STANDARD_DEVIATION 9.9 | 69.1 Years STANDARD_DEVIATION 10.3 |
| Angina (Unknown) | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Current Diabetes Mellitus | 186 Participants | 118 Participants | 8 Participants | 17 Participants | 43 Participants |
| History of Cerebrovascular Accident (CVA) | 51 Participants | 36 Participants | 2 Participants | 2 Participants | 11 Participants |
| History of Chronic Obstructive Pulmonary Disease | 84 Participants | 52 Participants | 2 Participants | 9 Participants | 21 Participants |
| History of Claudication | 423 Participants | 271 Participants | 12 Participants | 50 Participants | 90 Participants |
| History of Congestive Heart Failure (CHF) | 36 Participants | 26 Participants | 0 Participants | 1 Participants | 9 Participants |
| History of Coronary Artery Bypass Graft (CABG) Surgery | 52 Participants | 35 Participants | 1 Participants | 1 Participants | 15 Participants |
| History of Coronary Artery Disease (CAD) | 196 Participants | 131 Participants | 7 Participants | 14 Participants | 44 Participants |
| History of Endovascular Interventions | 205 Participants | 131 Participants | 4 Participants | 23 Participants | 47 Participants |
| History of Hyperlipidemia requiring medication | 341 Participants | 211 Participants | 10 Participants | 42 Participants | 78 Participants |
| History of Hypertension requiring medication | 377 Participants | 251 Participants | 9 Participants | 37 Participants | 80 Participants |
| History of Myocardial Infarction (MI) | 70 Participants | 46 Participants | 4 Participants | 6 Participants | 14 Participants |
| History of Percutaneous Coronary Intervention (PCI) | 125 Participants | 81 Participants | 2 Participants | 8 Participants | 34 Participants |
| History of Peripheral Vascular Surgery | 41 Participants | 24 Participants | 0 Participants | 8 Participants | 9 Participants |
| History of Renal Insufficiency | 44 Participants | 30 Participants | 3 Participants | 6 Participants | 5 Participants |
| History of Renal Percutaneous Intervention | 7 Participants | 6 Participants | 0 Participants | 0 Participants | 1 Participants |
| History of Smoking (Current) | 162 Participants | 87 Participants | 6 Participants | 24 Participants | 45 Participants |
| History of Smoking (Never) | 61 Participants | 40 Participants | 1 Participants | 5 Participants | 15 Participants |
| History of Smoking (Previous) | 216 Participants | 150 Participants | 5 Participants | 23 Participants | 38 Participants |
| History of Smoking (Unknown) | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| History of Transient Ischemic Attacks (TIA) | 26 Participants | 14 Participants | 0 Participants | 5 Participants | 7 Participants |
| No Angina | 389 Participants | 242 Participants | 12 Participants | 50 Participants | 85 Participants |
| NYHA Classification NYHA I Classification | 10 Participants | 10 Participants | — | 0 Participants | 0 Participants |
| NYHA Classification NYHA II Classification | 12 Participants | 6 Participants | — | 0 Participants | 6 Participants |
| NYHA Classification NYHA III Classification | 1 Participants | 1 Participants | — | 0 Participants | 0 Participants |
| NYHA Classification NYHA IV Classification | 0 Participants | 0 Participants | — | 0 Participants | 0 Participants |
| NYHA Classification NYHA Unknown Classification | 13 Participants | 9 Participants | — | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian (Japanese) | 102 Participants | 77 Participants | 0 Participants | 0 Participants | 25 Participants |
| Race/Ethnicity, Customized Black, or African Heritage | 28 Participants | 20 Participants | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Caucasian | 274 Participants | 155 Participants | 9 Participants | 51 Participants | 59 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 29 Participants | 21 Participants | 0 Participants | 0 Participants | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Disclosed | 5 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Canada | 16 participants | 12 participants | 0 participants | 0 participants | 4 participants |
| Region of Enrollment Europe | 87 participants | 29 participants | 0 participants | 50 participants | 8 participants |
| Region of Enrollment Japan | 102 participants | 77 participants | 0 participants | 0 participants | 25 participants |
| Region of Enrollment New Zealand | 11 participants | 7 participants | 0 participants | 2 participants | 2 participants |
| Region of Enrollment United States | 224 participants | 153 participants | 12 participants | 0 participants | 59 participants |
| Sex: Female, Male Female | 158 Participants | 105 Participants | 8 Participants | 14 Participants | 31 Participants |
| Sex: Female, Male Male | 282 Participants | 173 Participants | 4 Participants | 38 Participants | 67 Participants |
| Stable Angina | 49 Participants | 35 Participants | 0 Participants | 1 Participants | 13 Participants |
| Unstable Angina | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 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 | 44 / 278 | 20 / 98 | 2 / 52 | 3 / 12 |
| other Total, other adverse events | 176 / 278 | 63 / 98 | 26 / 52 | 9 / 12 |
| serious Total, serious adverse events | 212 / 278 | 73 / 98 | 23 / 52 | 10 / 12 |
Outcome results
Primary
Major Adverse Events (MAEs) (Primary Safety Endpoint)
RCT: MAE is defined as a composite of freedom from all-cause death through 1 month, target limb major amputation (defined as at or above the ankle) within 12 months, and/or Target Lesion Revascularization (TLR) within 12 months. LB Substudy: Primary safety endpoint assesses the occurrence of MAE defined as all-cause death through 1 month, target limb major amputation and/or TLR at 6 and 12 months post-index procedure. PK Substudy: There was no prespecified analysis of primary safety endpoint.
Time frame: Primary safety endpoint assessed at 12 months for RCT study and at both 6 and 12 months for LB substudy.
Population: PK Substudy: There was no prespecified analysis of primary safety endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Major Adverse Events (MAEs) (Primary Safety Endpoint) | 12 Month Primary Safety Endpoint | 241 Participants |
| Standard Balloon Angioplasty RCT | Major Adverse Events (MAEs) (Primary Safety Endpoint) | 12 Month Primary Safety Endpoint | 76 Participants |
| Long Balloon (LB) Substudy | Major Adverse Events (MAEs) (Primary Safety Endpoint) | 6 Month Primary Safety Endpoint | 50 Participants |
| Long Balloon (LB) Substudy | Major Adverse Events (MAEs) (Primary Safety Endpoint) | 12 Month Primary Safety Endpoint | 47 Participants |
p-value: <0.0001Chi-squared
Primary
Number of Participants With Primary Lesion Patency
RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR \>2.4 suggests \>50% stenosis. LB Substudy outcome measure: Primary patency of the target lesion is determined by duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤ 2.4 in absence of clinically-driven TLR. Primary effectiveness endpoint is assessed at 6 months post-procedure. PK Substudy: There was no prespecified analysis of primary lesion patency.
Time frame: 12 months (RCT); 6 months (LB substudy)
Population: Percentage (%) of lesions that reach endpoint without a hemodynamically significant stenosis on DUS and without clinically-driven TLR or bypass of the target lesion.~PK Substudy: There was no prespecified analysis of primary lesion patency.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Primary Lesion Patency | 194 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Primary Lesion Patency | 57 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Primary Lesion Patency | 43 Participants |
p-value: 0.0017Chi-squared
Secondary
Changes in Healthcare Utilization Over Time
Changes in healthcare utilization over time as measured by hospitalization readmission. Readmission Rate represents (# of subjects/Total enrolled subjects) who were hospitalized due to TLR/TVR or due to Procedure/Device related AE. LB Substudy: Follow-up through 12 Month. PK Substudy: There was no prespecified analysis of healthcare utilization over time for the PK Substudy.
Time frame: 1, 6, 12, 24, 36, 48 and 60-months post-procedure (RCT); 1, 6, 12-months post-procedure (LB substudy)
Population: Hospitalization readmission rates are based on number of enrolled subjects.~LB Substudy: Follow-up through 12 Month. PK Substudy: There was no prespecified analysis of healthcare utilization over time for the PK Substudy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Changes in Healthcare Utilization Over Time | 6-month Readmission Rate | 8 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Changes in Healthcare Utilization Over Time | 48-Month Readmission Rate | 37 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Changes in Healthcare Utilization Over Time | 24-Month Readmission Rate | 28 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Changes in Healthcare Utilization Over Time | 1-Month Readmission Rate | 6 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Changes in Healthcare Utilization Over Time | 36-month Readmission Rate | 33 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Changes in Healthcare Utilization Over Time | 60-Month Readmission Rate | 41 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Changes in Healthcare Utilization Over Time | 12-Month Readmission Rate | 18 Participants |
| Standard Balloon Angioplasty RCT | Changes in Healthcare Utilization Over Time | 60-Month Readmission Rate | 16 Participants |
| Standard Balloon Angioplasty RCT | Changes in Healthcare Utilization Over Time | 1-Month Readmission Rate | 4 Participants |
| Standard Balloon Angioplasty RCT | Changes in Healthcare Utilization Over Time | 6-month Readmission Rate | 5 Participants |
| Standard Balloon Angioplasty RCT | Changes in Healthcare Utilization Over Time | 12-Month Readmission Rate | 9 Participants |
| Standard Balloon Angioplasty RCT | Changes in Healthcare Utilization Over Time | 24-Month Readmission Rate | 13 Participants |
| Standard Balloon Angioplasty RCT | Changes in Healthcare Utilization Over Time | 36-month Readmission Rate | 15 Participants |
| Standard Balloon Angioplasty RCT | Changes in Healthcare Utilization Over Time | 48-Month Readmission Rate | 16 Participants |
| Long Balloon (LB) Substudy | Changes in Healthcare Utilization Over Time | 1-Month Readmission Rate | 1 Participants |
| Long Balloon (LB) Substudy | Changes in Healthcare Utilization Over Time | 6-month Readmission Rate | 1 Participants |
| Long Balloon (LB) Substudy | Changes in Healthcare Utilization Over Time | 12-Month Readmission Rate | 3 Participants |
Secondary
Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion
Duplex-defined binary restenosis (PSVR \> 2.4) of the target lesion at 1, 6, 12, 24 and 36 Months (RCT) Duplex-defined binary restenosis (PSVR \> 2.4) of the target lesion at 1, 6, and 12 (LB Substudy) PK Substudy: There was no prespecified analysis of duplex defined binary restenosis of the target lesion
Time frame: 1, 6, 12, 24, and 36-months post-procedure (RCT); 1, 6, and 12-months post-procedure (LB substudy)
Population: Only subjects with Diagnostic and readable PSVR values are included in the analysis.~PK Substudy: There was no prespecified analysis of duplex defined binary restenosis of the target lesion
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 1-month PSVR > 2.4 | 7 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 36-month PSVR > 2.4 | 17 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 12-month PSVR > 2.4 | 21 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 24-month PSVR > 2.4 | 17 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 6-month PSVR > 2.4 | 8 Participants |
| Standard Balloon Angioplasty RCT | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 36-month PSVR > 2.4 | 5 Participants |
| Standard Balloon Angioplasty RCT | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 1-month PSVR > 2.4 | 0 Participants |
| Standard Balloon Angioplasty RCT | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 6-month PSVR > 2.4 | 12 Participants |
| Standard Balloon Angioplasty RCT | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 12-month PSVR > 2.4 | 8 Participants |
| Standard Balloon Angioplasty RCT | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 24-month PSVR > 2.4 | 6 Participants |
| Long Balloon (LB) Substudy | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 1-month PSVR > 2.4 | 3 Participants |
| Long Balloon (LB) Substudy | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 6-month PSVR > 2.4 | 2 Participants |
| Long Balloon (LB) Substudy | Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion | 12-month PSVR > 2.4 | 3 Participants |
Secondary
Number of Clinical Events Committee (CEC) Adjudicated Events
CEC adjudicated events including death of any cause, target lesion revascularization (TLR), target vessel revascularization (TVR) and target limb amputation (TLA). Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reaches (or is beyond) the earliest visit window. LB substudy follow-up through 12 month.
Time frame: 1, 6, 12, 24, 36, 48 and 60 months (RCT and PK substudy); 1, 6 and 12 months (LB substudy)
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 reaches (or is beyond) the earliest visit window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Deaths | 29 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Deaths | 40 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Limb Amputation | 1 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Target Limb Amputation | 1 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Lesion Revascularization (TLR) | 0 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Target Vessel Revascularization (TVR) | 64 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Deaths | 3 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Target Vessel Revascularization (TVR) | 49 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Lesion Revascularization (TLR) | 14 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 12- Month All Deaths | 5 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Limb Amputation | 0 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Target Limb Amputation | 2 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Vessel Revascularization (TVR) | 16 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Target Limb Amputation | 1 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Target Limb Amputation | 3 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Lesion Revascularization (TLR) | 2 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Limb Amputation | 1 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Deaths | 36 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Vessel Revascularization (TVR) | 0 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Target Vessel Revascularization (TVR) | 60 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Deaths | 14 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Target Lesion Revascularization (TLR) | 56 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Deaths | 1 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Target Lesion Revascularization (TLR) | 32 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Vessel Revascularization (TVR) | 3 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Target Lesion Revascularization (TLR) | 52 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Target Vessel Revascularization (TVR) | 38 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Target Lesion Revascularization (TLR) | 42 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Target Vessel Revascularization (TVR) | 20 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Target Limb Amputation | 1 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Deaths | 5 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Target Limb Amputation | 3 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Target Lesion Revascularization (TLR) | 21 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Target Vessel Revascularization (TVR) | 23 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Vessel Revascularization (TVR) | 0 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Target Vessel Revascularization (TVR) | 26 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Limb Amputation | 0 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Deaths | 0 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Deaths | 2 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Target Lesion Revascularization (TLR) | 23 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Lesion Revascularization (TLR) | 3 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Deaths | 16 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Vessel Revascularization (TVR) | 3 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Target Limb Amputation | 3 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Limb Amputation | 0 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 12- Month All Deaths | 2 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Lesion Revascularization (TLR) | 0 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Target Limb Amputation | 3 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Lesion Revascularization (TLR) | 15 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Vessel Revascularization (TVR) | 15 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Target Vessel Revascularization (TVR) | 26 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Limb Amputation | 0 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Deaths | 3 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Target Lesion Revascularization (TLR) | 23 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Target Lesion Revascularization (TLR) | 19 Participants |
| Standard Balloon Angioplasty RCT | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Deaths | 10 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Lesion Revascularization (TLR) | 1 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Deaths | 0 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Lesion Revascularization (TLR) | 1 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Vessel Revascularization (TVR) | 1 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Limb Amputation | 0 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Deaths | 2 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Vessel Revascularization (TVR) | 1 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Limb Amputation | 0 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 12- Month All Deaths | 3 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Lesion Revascularization (TLR) | 3 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Vessel Revascularization (TVR) | 3 Participants |
| Long Balloon (LB) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Limb Amputation | 0 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Target Vessel Revascularization (TVR) | 4 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Target Lesion Revascularization (TLR) | 3 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Deaths | 1 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 36-Month All Target Limb Amputation | 1 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Target Limb Amputation | 1 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Target Vessel Revascularization (TVR) | 4 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Deaths | 2 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Target Lesion Revascularization (TLR) | 3 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 24-Month All Deaths | 1 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Target Lesion Revascularization (TLR) | 3 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Limb Amputation | 1 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Vessel Revascularization (TVR) | 3 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Target Vessel Revascularization (TVR) | 4 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 12-Month All Target Lesion Revascularization (TLR) | 2 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 12- Month All Deaths | 1 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 48-Month All Target Limb Amputation | 1 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Vessel Revascularization (TVR) | 0 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Lesion Revascularization (TLR) | 0 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Deaths | 2 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Target Limb Amputation | 0 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 6-Month All Deaths | 1 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Target Lesion Revascularization (TLR) | 3 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Limb Amputation | 0 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Vessel Revascularization (TVR) | 0 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Target Vessel Revascularization (TVR) | 4 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Target Lesion Revascularization (TLR) | 0 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 1-Month All Deaths | 0 Participants |
| Pharmacokinetics (PK) Substudy | Number of Clinical Events Committee (CEC) Adjudicated Events | 60-Month All Target Limb Amputation | 1 Participants |
Secondary
Number of Major Adverse Event (MAE) Assessment
MAEs defined as all-cause of death post-index procedure (30-days), target limb major amputation, and/or target lesion revascularization (TLR) through 60-months in RCT. MAEs defined as all-cause of death post-index procedure (30-days), target limb major amputation, and/or target lesion revascularization (TLR) through 12-months in LB substudy. PK Substudy: There was no prespecified analysis of MAEs for PK substudy.
Time frame: 60-months (RCT); 12-months (LB substudy).
Population: MAE assessment rates are based on number of evaluable subjects - subjects with the data point collected.~PK Substudy: There was no prespecified analysis of MAEs for PK substudy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Major Adverse Event (MAE) Assessment | 60-Month Target Limb Major Amputation | 1 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Major Adverse Event (MAE) Assessment | 12-Month Target Lesion Revascularization | 14 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Major Adverse Event (MAE) Assessment | 12-Month MAE (Composite Endpoint) | 15 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Major Adverse Event (MAE) Assessment | 60-Month All Causes of Death at 1-Month | 1 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Major Adverse Event (MAE) Assessment | 60-Month MAE (Composite Endpoint) | 57 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Major Adverse Event (MAE) Assessment | 60-Month Target Lesion Revascularization | 56 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Major Adverse Event (MAE) Assessment | 12-Month Target Limb Major Amputation | 0 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Major Adverse Event (MAE) Assessment | 12-Month All Causes of Death at 1-Month | 1 Participants |
| Standard Balloon Angioplasty RCT | Number of Major Adverse Event (MAE) Assessment | 60-Month Target Lesion Revascularization | 23 Participants |
| Standard Balloon Angioplasty RCT | Number of Major Adverse Event (MAE) Assessment | 12-Month MAE (Composite Endpoint) | 15 Participants |
| Standard Balloon Angioplasty RCT | Number of Major Adverse Event (MAE) Assessment | 12-Month All Causes of Death at 1-Month | 0 Participants |
| Standard Balloon Angioplasty RCT | Number of Major Adverse Event (MAE) Assessment | 12-Month Target Limb Major Amputation | 0 Participants |
| Standard Balloon Angioplasty RCT | Number of Major Adverse Event (MAE) Assessment | 12-Month Target Lesion Revascularization | 15 Participants |
| Standard Balloon Angioplasty RCT | Number of Major Adverse Event (MAE) Assessment | 60-Month MAE (Composite Endpoint) | 23 Participants |
| Standard Balloon Angioplasty RCT | Number of Major Adverse Event (MAE) Assessment | 60-Month All Causes of Death at 1-Month | 0 Participants |
| Standard Balloon Angioplasty RCT | Number of Major Adverse Event (MAE) Assessment | 60-Month Target Limb Major Amputation | 0 Participants |
| Long Balloon (LB) Substudy | Number of Major Adverse Event (MAE) Assessment | 12-Month Target Limb Major Amputation | 0 Participants |
| Long Balloon (LB) Substudy | Number of Major Adverse Event (MAE) Assessment | 12-Month MAE (Composite Endpoint) | 3 Participants |
| Long Balloon (LB) Substudy | Number of Major Adverse Event (MAE) Assessment | 12-Month Target Lesion Revascularization | 3 Participants |
| Long Balloon (LB) Substudy | Number of Major Adverse Event (MAE) Assessment | 12-Month All Causes of Death at 1-Month | 0 Participants |
Secondary
Number of Participants With Clinical Success Rate Assessment
Clinical success defined as procedural success without procedural complications including death, major target limb amputation, thrombosis of the target lesion, or clinically-driven TLR prior to discharge.
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Clinical Success Rate Assessment | 267 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Clinical Success Rate Assessment | 96 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Clinical Success Rate Assessment | 48 Participants |
| Pharmacokinetics (PK) Substudy | Number of Participants With Clinical Success Rate Assessment | 11 Participants |
Secondary
Number of Participants With Procedural Success of Angioplasty Procedure
Procedural success defined as residual stenosis of less than or equal to 50% (non-stented subjects) or less than or equal to 30% (stented subjects) by core laboratory evaluation.
Time frame: Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Procedural Success of Angioplasty Procedure | 269 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Procedural Success of Angioplasty Procedure | 97 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Procedural Success of Angioplasty Procedure | 49 Participants |
| Pharmacokinetics (PK) Substudy | Number of Participants With Procedural Success of Angioplasty Procedure | 12 Participants |
Secondary
Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline.
Improvement of ABI by ≥ 0.1 or to an ABI ≥ 0.90 as compared to the pre-procedure value without the need for repeat revascularization. LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Hemodynamic Improvement for PK substudy.
Time frame: 1, 6, 12, 24, and 36 months post-procedure (RCT); 1, 6, and 12 months post-procedure (LB substudy)
Population: Hemodynamic improvement rates are based on number of evaluable subjects - subjects with the data point collected.~LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Hemodynamic Improvement for PK substudy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 1-Month Hemodynamic Improvement | 252 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 6-Month Hemodynamic Improvement | 230 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 12-Month Hemodynamic Improvement | 202 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 24-Month Hemodynamic Improvement | 166 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 36-Month Hemodynamic Improvement | 128 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 6-Month Hemodynamic Improvement | 66 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 24-Month Hemodynamic Improvement | 47 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 12-Month Hemodynamic Improvement | 57 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 1-Month Hemodynamic Improvement | 83 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 36-Month Hemodynamic Improvement | 45 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 1-Month Hemodynamic Improvement | 43 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 12-Month Hemodynamic Improvement | 40 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Rate of Hemodynamic Improvement as Assessed by Changes in Ankle Brachial Index (ABI) From Baseline. | 6-Month Hemodynamic Improvement | 43 Participants |
Secondary
Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline
Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure without the need for repeat TLR. LB Substudy: Follow-up through 12-month. PK Substudy: There was no prespecified analysis of Rate of Primary Sustained Clinical Improvement for PK substudy.
Time frame: 1, 6, 12, 24 and 36 months post-procedure (RCT); 1, 6 and 12 months post-procedure (LB substudy).
Population: Primary sustained clinical improvement rates are based on number of evaluable subjects - subjects with the data point collected.~LB Substudy: Follow-up through 12-month. PK Substudy: There was no prespecified analysis of Rate of Primary Sustained Clinical Improvement for PK substudy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 1-Month Primary Sustained Clinical Improvement | 256 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 6-Month Primary Sustained Clinical Improvement | 249 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 12-Month Primary Sustained Clinical Improvement | 222 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 24-Month Primary Sustained Clinical Improvement | 180 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 36-Month Primary Sustained Clinical Improvement | 150 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 6-Month Primary Sustained Clinical Improvement | 83 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 24-Month Primary Sustained Clinical Improvement | 59 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 12-Month Primary Sustained Clinical Improvement | 69 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 1-Month Primary Sustained Clinical Improvement | 91 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 36-Month Primary Sustained Clinical Improvement | 53 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 1-Month Primary Sustained Clinical Improvement | 50 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 12-Month Primary Sustained Clinical Improvement | 45 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | 6-Month Primary Sustained Clinical Improvement | 48 Participants |
Secondary
Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline.
Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR. LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Secondary Sustained Clinical Improvement for PK substudy.
Time frame: 1, 6, 12, 24 and 36 months post-procedure (RCT): 1, 6, and 12 months post-procedure (LB substudy)
Population: Secondary sustained clinical improvement rates are based on number of evaluable subjects - subjects with the data point collected.~LB Substudy: Follow-up through 12-months. PK Substudy: There was no prespecified analysis of Rate of Secondary Sustained Clinical Improvement for PK substudy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 1-Month Secondary Sustained Clinical Improvement | 256 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 6-Month Secondary Sustained Clinical Improvement | 251 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 12-Month Secondary Sustained Clinical Improvement | 230 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 24-Month Secondary Sustained Clinical Improvement | 205 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 36-Month Secondary Sustained Clinical Improvement | 176 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 6-Month Secondary Sustained Clinical Improvement | 85 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 24-Month Secondary Sustained Clinical Improvement | 73 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 12-Month Secondary Sustained Clinical Improvement | 81 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 1-Month Secondary Sustained Clinical Improvement | 91 Participants |
| Standard Balloon Angioplasty RCT | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 36-Month Secondary Sustained Clinical Improvement | 67 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 1-Month Secondary Sustained Clinical Improvement | 51 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 12-Month Secondary Sustained Clinical Improvement | 47 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Rate of Secondary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline. | 6-Month Secondary Sustained Clinical Improvement | 48 Participants |
Secondary
Number of Participants With Technical Success of Angioplasty Procedure
Technical success defined as successful delivery, balloon inflation and deflation and retrieval of the intact trial device without burst below the rated burst pressure. RCT Standard Balloon Angioplasty: Device deficiency data is only collected for Ranger DCB; data not collected for Standard PTA group; there is no pre-specified analysis of this outcome for the Standard PTA group.
Time frame: Day 0
Population: RCT: Device deficiency data is only collected for Ranger DCB; data not collected for Standard PTA group; there is no pre-specified analysis of this outcome for the Standard PTA group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Number of Participants With Technical Success of Angioplasty Procedure | 277 Participants |
| Long Balloon (LB) Substudy | Number of Participants With Technical Success of Angioplasty Procedure | 47 Participants |
| Pharmacokinetics (PK) Substudy | Number of Participants With Technical Success of Angioplasty Procedure | 12 Participants |
Secondary
Patient Utility Values as Assessed by Change in EQ-5D From Baseline.
Patient Utility Values as assessed by change in EQ-5D from baseline at 1, 6, 12, 24 and 36-months post-procedure. The EuroQOL (EQ)-5D is a multi-attribute health classification system. The EQ-5D uses a 5-dimension (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) descriptive system, which each consisting of 5 response options (no problems, slight problems, moderate problems, severe problems, or extreme problems/inability to perform). Outcomes reported as Improvement defined as improving at least one category from baseline. LB Substudy: There was no prespecified analysis of Patient Utility Values for the LB Substudy. PK Substudy: There was no prespecified analysis of Patient Utility Values for the PK Substudy.
Time frame: 1, 6, 12, 24 and 36-months post-procedure (RCT).
Population: Patient Utility Value improvement rates are based on number of evaluable subjects - subjects with the data point collected.~LB Substudy: There was no prespecified analysis of Patient Utility Values for the LB Substudy.~PK Substudy: There was no prespecified analysis of Patient Utility Values for the PK Substudy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 24-Month Pain/Discomfort Improvement | 108 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 1-Month Self-Care Improvement | 24 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 1-Month Usual Activities Improvement | 107 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 1-Month Pain/Discomfort Improvement | 141 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 1-Month Anxiety/Depression Improvement | 55 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 6-Months Mobility Improvement | 149 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 6-Month Self-Care Improvement | 27 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 6-Month Usual Activities Improvement | 102 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 6-Month Pain/Discomfort Improvement | 126 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 6-Month Anxiety/Depression Improvement | 61 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 12-Months Mobility Improvement | 140 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 36-Month Pain/Discomfort Improvement | 96 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 12-Month Self-Care Improvement | 26 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 12-Month Usual Activities Improvement | 94 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 12-Month Pain/Discomfort Improvement | 132 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 12-Month Anxiety/Depression Improvement | 59 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 24-Months Mobility Improvement | 109 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 24-Month Self-Care Improvement | 17 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 24-Month Usual Activities Improvement | 87 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 1-Month Mobility Improvement | 149 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 24-Month Anxiety/Depression Improvement | 47 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 36-Months Mobility Improvement | 100 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 36-Month Self-Care Improvement | 17 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 36-Month Usual Activities Improvement | 80 Participants |
| RANGER™ Paclitaxel Coated Balloon RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 36-Month Anxiety/Depression Improvement | 54 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 24-Month Pain/Discomfort Improvement | 48 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 1-Month Mobility Improvement | 52 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 12-Month Usual Activities Improvement | 41 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 1-Month Self-Care Improvement | 12 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 36-Month Anxiety/Depression Improvement | 16 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 1-Month Usual Activities Improvement | 44 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 12-Month Pain/Discomfort Improvement | 51 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 1-Month Pain/Discomfort Improvement | 61 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 24-Month Anxiety/Depression Improvement | 17 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 1-Month Anxiety/Depression Improvement | 23 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 12-Month Anxiety/Depression Improvement | 22 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 6-Months Mobility Improvement | 45 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 36-Month Usual Activities Improvement | 32 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 6-Month Self-Care Improvement | 10 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 24-Months Mobility Improvement | 42 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 6-Month Usual Activities Improvement | 38 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 36-Months Mobility Improvement | 37 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 6-Month Pain/Discomfort Improvement | 47 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 24-Month Self-Care Improvement | 12 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 6-Month Anxiety/Depression Improvement | 24 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 36-Month Pain/Discomfort Improvement | 38 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 12-Months Mobility Improvement | 48 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 24-Month Usual Activities Improvement | 38 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 36-Month Self-Care Improvement | 8 Participants |
| Standard Balloon Angioplasty RCT | Patient Utility Values as Assessed by Change in EQ-5D From Baseline. | 12-Month Self-Care Improvement | 14 Participants |
Secondary
PK Parameters - Area Under the Blood Concentration Versus Time Curve From Time Zero up to the Time of the Last Quantifiable Concentration, Calculated by Trapezoidal Methods.
Summary of Pharmacokinetic Parameters in PK substudy. AUC0-t (ng\*h/mL) = Area under the blood concentration versus time curve from time zero up to the time of the last quantifiable concentration, calculated by trapezoidal methods. PK parameter data not collected or analyzed in RCT or LB substudy.
Time frame: Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
Population: PK data not collected or analyzed in RCT or LB substudy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | PK Parameters - Area Under the Blood Concentration Versus Time Curve From Time Zero up to the Time of the Last Quantifiable Concentration, Calculated by Trapezoidal Methods. | 0.86 ng*h/mL | Standard Deviation 0.76 |
Secondary
PK Parameters - Maximum Plasma Concentration
Summary of Pharmacokinetic Parameters in PK substudy. cmax (ng/mL) = Maximum plasma concentration PK data not collected or analyzed in RCT or LB substudy.
Time frame: Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
Population: PK data not collected or analyzed in RCT or LB substudy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | PK Parameters - Maximum Plasma Concentration | 2.50 ng/mL | Standard Deviation 2.17 |
Secondary
PK Parameters Paclitaxel (PTx) Dose
Summary of Pharmacokinetic Parameters in PK substudy. Paclitaxel (PTx) Dose PK parameter data not collected or analyzed in RCT or LB substudy.
Time frame: Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
Population: PK parameter data not collected or analyzed in RCT or LB substudy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | PK Parameters Paclitaxel (PTx) Dose | 6136.6 μg | Standard Deviation 2554.3 |
Secondary
PK Parameters - Tmax
Summary of Pharmacokinetic Parameters in PK substudy. - Tmax Tmax (h) = The timepoint where cmax is reached PK parameter data not collected or analyzed in RCT or LB substudy.
Time frame: Time points for analysis are a venous blood draw at screening, followed by blood draws at 10 minutes, 30 minutes, 1 hour, 3 hours, 6 hours and 24 or 48 hours after last Ranger DCB balloon removal, as well as 7 days and 30 days post index procedure.
Population: PK data not collected or analyzed in RCT or LB substudy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | PK Parameters - Tmax | 0.17 hours (h) | Standard Deviation 0 |
Secondary
Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline.
The WIQ is a functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability. It also assesses the reasons that walking ability might be limited. Range of scores include 0% (worst score) to 100% (best score). Walking improvement change assessed from baseline. LB Substudy: There was no prespecified analysis of Walking Improvement for the LB substudy. PK Substudy: There was no prespecified analysis of Walking Improvement for the PK substudy.
Time frame: 1, 6, 12, 24 and 36 months post-procedure (RCT)
Population: Walking improvement rates are based on number of evaluable subjects - subjects with the data point collected.~LB Substudy: There was no prespecified analysis of Walking Improvement for the LB substudy.~PK Substudy: There was no prespecified analysis of Walking Improvement for the PK substudy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline. | 6-Month Walking Improvement Scoring Summary | 32.25 Percentage increase | Standard Deviation 37.07 |
| RANGER™ Paclitaxel Coated Balloon RCT | Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline. | 24-Month Walking Improvement Scoring Summary | 29.50 Percentage increase | Standard Deviation 36.87 |
| RANGER™ Paclitaxel Coated Balloon RCT | Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline. | 12-Month Walking Improvement Scoring Summary | 32.06 Percentage increase | Standard Deviation 39.49 |
| RANGER™ Paclitaxel Coated Balloon RCT | Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline. | 36-Month Walking Improvement | 30.37 Percentage increase | Standard Deviation 38.85 |
| RANGER™ Paclitaxel Coated Balloon RCT | Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline. | 1-Month Walking Improvement Scoring Summary | 33.61 Percentage increase | Standard Deviation 35.78 |
| Standard Balloon Angioplasty RCT | Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline. | 36-Month Walking Improvement | 34.93 Percentage increase | Standard Deviation 39.03 |
| Standard Balloon Angioplasty RCT | Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline. | 1-Month Walking Improvement Scoring Summary | 34.47 Percentage increase | Standard Deviation 35.2 |
| Standard Balloon Angioplasty RCT | Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline. | 6-Month Walking Improvement Scoring Summary | 32.25 Percentage increase | Standard Deviation 37.07 |
| Standard Balloon Angioplasty RCT | Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline. | 12-Month Walking Improvement Scoring Summary | 34.72 Percentage increase | Standard Deviation 36.85 |
| Standard Balloon Angioplasty RCT | Walking Improvement Assessed by Change in Walking Impairment Questionnaire (WIQ) From Baseline. | 24-Month Walking Improvement Scoring Summary | 29.76 Percentage increase | Standard Deviation 41.88 |
Secondary
Walking Improvement (Distance) at 6 and 12 Months as Assessed by Change in Six Minute Walk Test (6MWT) From Baseline
The 6MWT measure the maximal walking distance that a patient achieves on a flat, hard surface within a period of 6 minutes. It evaluates the global and integrated responses of all physiological systems involved during exercise including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, neuromuscular units and muscle metabolism. Change in distance walked from baseline to 12 months. LB Substudy: There was no prespecified analysis of Walking Improvement (distance) for the LB substudy. PK Substudy: There was no prespecified analysis of Walking Improvement (distance) for PK substudy.
Time frame: 6 and 12 months post-procedure (RCT)
Population: Data provided is total distance walked (m) change from baseline. Walking Improvement (distance) assessed by change in Six Minute Walk Test (6MWT) is based on number of evaluable subjects - subjects with data point collected.~LB Substudy: There was no prespecified analysis of Walking Improvement (distance) for the LB substudy.~PK Substudy: There was no prespecified analysis of Walking Improvement (distance) for PK substudy.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RANGER™ Paclitaxel Coated Balloon RCT | Walking Improvement (Distance) at 6 and 12 Months as Assessed by Change in Six Minute Walk Test (6MWT) From Baseline | 6-Month Walking Improvement (Distance) | 40.7 Meters | Standard Deviation 179 |
| RANGER™ Paclitaxel Coated Balloon RCT | Walking Improvement (Distance) at 6 and 12 Months as Assessed by Change in Six Minute Walk Test (6MWT) From Baseline | 12-Month Walking Improvement (Distance) | 36.3 Meters | Standard Deviation 162.2 |
| Standard Balloon Angioplasty RCT | Walking Improvement (Distance) at 6 and 12 Months as Assessed by Change in Six Minute Walk Test (6MWT) From Baseline | 6-Month Walking Improvement (Distance) | 55.9 Meters | Standard Deviation 117.5 |
| Standard Balloon Angioplasty RCT | Walking Improvement (Distance) at 6 and 12 Months as Assessed by Change in Six Minute Walk Test (6MWT) From Baseline | 12-Month Walking Improvement (Distance) | 46.1 Meters | Standard Deviation 115.4 |