Peripheral Artery Disease
Conditions
Brief summary
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
Detailed description
The objective of this continued follow-up of ILLUMENATE Pivotal Study subjects is to demonstrate the long term safety and effectiveness of the Stellarex DCB. Each enrolled subject will be followed for 5 years (60 months) after treatment. A follow-up office visit will occur at 24 and 36 months. A follow-up telephone contact or an optional office visit will occur at 48 and 60 months.
Interventions
DEVICEStellarex 0.035 OTW Drug-coated Angioplasty Balloon
The Stellarex 0.035 OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
DEVICEEverCross™ 0.035 PTA Balloon Catheter
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Sponsors
Spectranetics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- From ILLUMENATE Pivotal IDE population TP-1397E Study subjects must fulfill the following clinical criteria: 1. Symptomatic leg ischemia, requiring treatment of the superficial femoral artery (SFA) and/or popliteal artery. 2. Greater than or equal to 18 years of age. 3. Willing to provide written informed consent, and capable and willing to comply with all required follow-up evaluations within the defined follow-up visit windows. 4. Will not undergo other planned vascular interventions within 14 days before and/or 30 days after the protocol treatment (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment). 5. Life expectancy \>1 year. 6. Rutherford-Becker classification of 2, 3 or 4. Study Subjects must fulfill the following angiographic criteria: 7. De novo or restenotic lesion (except for in-stent restenotic lesion) \>70% within the SFA and/or popliteal artery in a single limb. 8. Single lesion which is ≥3 cm and ≤18cm in length (by visual estimation). NOTE: Tandem lesions can be treated. A tandem lesion is defined as two distinct lesions with 3 cm or less of healthy vessel separating the two diseased areas. The total cumulative length of the tandem lesions, including the healthy vessel, must not exceed 18 cm. 9. Lesion is treatable by no more than two (2) study devices. 10. Successful wire crossing of the lesion. The guidewire advancement should not be indicative of the presence of fresh thrombus in the lesion. 11. Target reference vessel diameter is ≥4 mm and ≤6 mm (by visual estimation). 12. Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as confirmed by angiography. Treatment of a target lesion is acceptable after successful treatment of inflow artery lesion(s). NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis \<30% without death or major vascular complication. 13. Target limb with at least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior magnetic resonance (MR) angiography or computed tomography (CT) angiography (within 45 days prior to index procedure). NOTE: treatment of outflow disease is NOT permitted.
Exclusion criteria
- Subject with any of the following clinical criteria should be excluded: 1. Females who are pregnant, lactating, or intend to become pregnant, or males who intend to father children during study participation. 2. Known aortic aneurysm(s) \> 5 cm. 3. Contraindication to dual anti-platelet therapy. 4. Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated. 5. Current participation in an investigational drug or another device study. 6. History of hemorrhagic stroke within 3 months. 7. Previous or planned surgical or interventional procedure within 14 days before or 30 days after the index procedure (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment). 8. Prior endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. stents/stent grafts, cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure, or any previous placement of a bypass graft proximal to the target lesion. 9. Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter. 10. Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session. 11. Chronic renal insufficiency (dialysis dependent, or serum creatinine \>2.5 mg/dL within 30 days of index procedure). Subject with any of the following angiographic criteria should be excluded: 12. Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure. 13. No normal proximal arterial segment of the target vessel in which duplex ultrasound velocity ratios can be measured. 14. Known inadequate distal outflow. 15. Acute or sub-acute thrombus in the target vessel. 16. Aneurysmal target vessel. 17. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) during the index procedure in the target lesion or target vessel. 18. Treatment of the contralateral limb during the same procedure or within 30 days following the study procedure (exclusive of the iliac arteries which can be treated prior to enrollment). 19. Presence of concentric calcification that precludes PTA pre-dilation. 20. Prior stent placement in the target vessel. 21. Residual stenosis of greater than 70%, stent placement or flow-limiting (Grade D or greater) dissection following pre-dilation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Target Vessel Patency at 24 Months Post-procedure | 24 months post-procedure | Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization. |
| Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure | 24 months post-procedure | The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 48 months post-procedure | Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). |
| Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 60 months post-procedure | Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). |
| Rate of Clinically-driven Target Lesion Revascularization | 24 months post-procedure | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion. |
| Rate of Target Lesion Revascularization | 24 months post-procedure | Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee |
| Rate of Clinically-driven Target Vessel Revascularization | 24 months post-procedure | Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index. |
| Rate of Target Limb Major Amputation | 24 months post-procedure | Number of subjects in which a major amputation occurred in the target limb |
| Mortality Rate | 24 months post-procedure | Number of subject who have died during the post-procedure follow up period |
| Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 24 months post-procedure | Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). |
| Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR | 24 months post-procedure | Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR |
| Change in Ankle-brachial Index (ABI) From Pre-procedure | 24 months post-procedure | The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease. |
| Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | 24 months post-procedure | A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication |
| Change in Walking Distance From Pre-procedure | 24 months post-procedure | Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit. |
| Change in Rutherford-Becker Classification From Pre-procedure | 24 months post-procedure | Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4\*-Ischemic rest pain 5\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \*Categories 4, 5, and 6 are also described as critical limb ischemia. |
| Change in EQ-5D Index From Pre-procedure | 24 months post-procedure | EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion. |
| Change in EQ-5D VAS From Pre-procedure | 24 months post procedure | EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion |
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 24 months post-procedure | Rate of occurrence of arterial thrombosis of the treated segment |
| Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 36 months post-procedure | Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). |
Countries
Austria, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DCB Subjects The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.
Basic Catheter Specifications
* Guidewire: 0.035
* Balloon Length: 40/80/120 mm
* Sheath Compatibility: greater than or equal to 6 French
* Balloon Diameter: 4/5/6 mm
* Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035 OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035 OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. | 200 |
| PTA Subjects The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Basic Catheter Specifications
* Guidewire: 0.035
* Balloon Length: 40/80/120 mm
* Sheath Compatibility: greater to or equal to 6 French
* Balloon Diameter: 4/5/6 mm
* Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.
EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). | 100 |
| Total | 300 |
Baseline characteristics
| Characteristic | DCB Subjects | PTA Subjects | Total |
|---|---|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 10.3 | 69.8 years STANDARD_DEVIATION 9.8 | 68.8 years STANDARD_DEVIATION 10.2 |
| Angina Pectoris | 30 Participants | 20 Participants | 50 Participants |
| Ankle-Brachial Index Ankle-Brachial Index Measurement | 0.75 ratio STANDARD_DEVIATION 0.21 | 0.76 ratio STANDARD_DEVIATION 0.2 | 0.75 ratio STANDARD_DEVIATION 0.21 |
| Ankle-Brachial Index Non-Compressible | NA ratio | — | NA ratio |
| Body Mass Index | 29.0 kg/m^2 STANDARD_DEVIATION 6.1 | 28.8 kg/m^2 STANDARD_DEVIATION 5.6 | 29.0 kg/m^2 STANDARD_DEVIATION 6 |
| Cerebrovascular Disease | 47 Participants | 20 Participants | 67 Participants |
| Chronic Obstructive Pulmonary Occlusion (COPD) | 32 Participants | 21 Participants | 53 Participants |
| Congestive Heart Failure (CHF) | 24 Participants | 8 Participants | 32 Participants |
| Deep Vein Thrombosis (DVT) | 6 Participants | 4 Participants | 10 Participants |
| Diabetes (Total) | 99 Participants | 52 Participants | 151 Participants |
| Diabetes - Type I | 8 Participants | 3 Participants | 11 Participants |
| Diabetes - Type II | 91 Participants | 49 Participants | 140 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 11 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 152 Participants | 77 Participants | 229 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 12 Participants | 33 Participants |
| Hyperlipidemia | 176 Participants | 90 Participants | 266 Participants |
| Hypertension | 187 Participants | 94 Participants | 281 Participants |
| Liver Disease | 7 Participants | 4 Participants | 11 Participants |
| Myocardial Infarction (MI) | 42 Participants | 22 Participants | 64 Participants |
| Peripheral Vascular Disease (PVD) | 200 Participants | 100 Participants | 300 Participants |
| Previous Intervention of the Lower Limb | 87 Participants | 41 Participants | 128 Participants |
| Previous Intervention of the Study Limb | 48 Participants | 23 Participants | 71 Participants |
| Previous Percutaneous or Surgical Coronary Revascularization | 90 Participants | 48 Participants | 138 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 19 Participants | 54 Participants |
| Race (NIH/OMB) More than one race | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | NA Participants | NA Participants | NA Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 12 Participants | 31 Participants |
| Race (NIH/OMB) White | 142 Participants | 68 Participants | 210 Participants |
| Region of Enrollment Austria | 17 participants | 10 participants | 27 participants |
| Region of Enrollment United States | 183 participants | 90 participants | 273 participants |
| Renal Insufficiency | 36 Participants | 17 Participants | 53 Participants |
| Rutherford-Becker Clinical Category RCC 2 | 63 Participants | 35 Participants | 98 Participants |
| Rutherford-Becker Clinical Category RCC 3 | 129 Participants | 60 Participants | 189 Participants |
| Rutherford-Becker Clinical Category RCC 4 | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Female | 88 Participants | 36 Participants | 124 Participants |
| Sex: Female, Male Male | 112 Participants | 64 Participants | 176 Participants |
| Smoker Never Smoked | 32 Participants | 24 Participants | 56 Participants |
| Smoker Previous or Current Smoker | 168 Participants | 76 Participants | 244 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 34 / 200 | 19 / 100 |
| other Total, other adverse events | 192 / 200 | 95 / 100 |
| serious Total, serious adverse events | 177 / 200 | 85 / 100 |
Outcome results
Primary
Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure
The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).
Time frame: 24 months post-procedure
Population: Subject was considered a failure if they experienced device or procedure-related death within 30 days, or if they experienced target limb major amputation or CD-TLR within 24 months (defined as 730 ± 45 days, i.e., up to 775 days). Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure | 142 Participants |
| PTA Subjects | Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure | 73 Participants |
Primary
Number of Participants With Target Vessel Patency at 24 Months Post-procedure
Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
Time frame: 24 months post-procedure
Population: Patency was defined as absence of target lesion restenosis (as assessed by the duplex ultrasound core laboratory based on PSVR ≤ 2.5) and CD-TLR through 24 months (defined as 730 ± 45 days, i.e., up to 775 days) or angiographic core laboratory assessment of restenosis. Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Number of Participants With Target Vessel Patency at 24 Months Post-procedure | 88 Participants |
| PTA Subjects | Number of Participants With Target Vessel Patency at 24 Months Post-procedure | 45 Participants |
Secondary
Change in Ankle-brachial Index (ABI) From Pre-procedure
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in Ankle-brachial Index (ABI) From Pre-procedure | Improved | 102 Participants |
| DCB Subjects | Change in Ankle-brachial Index (ABI) From Pre-procedure | No Change | 0 Participants |
| DCB Subjects | Change in Ankle-brachial Index (ABI) From Pre-procedure | Worsened | 39 Participants |
| PTA Subjects | Change in Ankle-brachial Index (ABI) From Pre-procedure | Improved | 56 Participants |
| PTA Subjects | Change in Ankle-brachial Index (ABI) From Pre-procedure | No Change | 1 Participants |
| PTA Subjects | Change in Ankle-brachial Index (ABI) From Pre-procedure | Worsened | 22 Participants |
Secondary
Change in Ankle-brachial Index (ABI) From Pre-procedure
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in Ankle-brachial Index (ABI) From Pre-procedure | Improved | 89 Participants |
| DCB Subjects | Change in Ankle-brachial Index (ABI) From Pre-procedure | Worsened | 31 Participants |
| PTA Subjects | Change in Ankle-brachial Index (ABI) From Pre-procedure | Improved | 46 Participants |
| PTA Subjects | Change in Ankle-brachial Index (ABI) From Pre-procedure | Worsened | 23 Participants |
Secondary
Change in EQ-5D Index From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in EQ-5D Index From Pre-procedure | Improved | 52 Participants |
| DCB Subjects | Change in EQ-5D Index From Pre-procedure | No Change | 15 Participants |
| DCB Subjects | Change in EQ-5D Index From Pre-procedure | Worsened | 28 Participants |
| PTA Subjects | Change in EQ-5D Index From Pre-procedure | Improved | 35 Participants |
| PTA Subjects | Change in EQ-5D Index From Pre-procedure | No Change | 6 Participants |
| PTA Subjects | Change in EQ-5D Index From Pre-procedure | Worsened | 15 Participants |
Secondary
Change in EQ-5D Index From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in EQ-5D Index From Pre-procedure | Improved | 62 Participants |
| DCB Subjects | Change in EQ-5D Index From Pre-procedure | No Change | 9 Participants |
| DCB Subjects | Change in EQ-5D Index From Pre-procedure | Worsened | 32 Participants |
| PTA Subjects | Change in EQ-5D Index From Pre-procedure | Improved | 37 Participants |
| PTA Subjects | Change in EQ-5D Index From Pre-procedure | No Change | 7 Participants |
| PTA Subjects | Change in EQ-5D Index From Pre-procedure | Worsened | 15 Participants |
Secondary
Change in EQ-5D VAS From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion
Time frame: 36 month post procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in EQ-5D VAS From Pre-procedure | No Change | 6 Participants |
| DCB Subjects | Change in EQ-5D VAS From Pre-procedure | Worsened | 36 Participants |
| DCB Subjects | Change in EQ-5D VAS From Pre-procedure | Improved | 53 Participants |
| PTA Subjects | Change in EQ-5D VAS From Pre-procedure | Improved | 26 Participants |
| PTA Subjects | Change in EQ-5D VAS From Pre-procedure | No Change | 9 Participants |
| PTA Subjects | Change in EQ-5D VAS From Pre-procedure | Worsened | 21 Participants |
Secondary
Change in EQ-5D VAS From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion
Time frame: 24 months post procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in EQ-5D VAS From Pre-procedure | Improved | 52 Participants |
| DCB Subjects | Change in EQ-5D VAS From Pre-procedure | No Change | 12 Participants |
| DCB Subjects | Change in EQ-5D VAS From Pre-procedure | Worsened | 40 Participants |
| PTA Subjects | Change in EQ-5D VAS From Pre-procedure | Improved | 30 Participants |
| PTA Subjects | Change in EQ-5D VAS From Pre-procedure | No Change | 10 Participants |
| PTA Subjects | Change in EQ-5D VAS From Pre-procedure | Worsened | 19 Participants |
Secondary
Change in Rutherford-Becker Classification From Pre-procedure
Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4\*-Ischemic rest pain 5\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \*Categories 4, 5, and 6 are also described as critical limb ischemia.
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in Rutherford-Becker Classification From Pre-procedure | Improved | 128 Participants |
| DCB Subjects | Change in Rutherford-Becker Classification From Pre-procedure | No Change | 17 Participants |
| DCB Subjects | Change in Rutherford-Becker Classification From Pre-procedure | Worsened | 8 Participants |
| PTA Subjects | Change in Rutherford-Becker Classification From Pre-procedure | Improved | 74 Participants |
| PTA Subjects | Change in Rutherford-Becker Classification From Pre-procedure | Worsened | 3 Participants |
| PTA Subjects | Change in Rutherford-Becker Classification From Pre-procedure | No Change | 5 Participants |
Secondary
Change in Rutherford-Becker Classification From Pre-procedure
Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4\*-Ischemic rest pain 5\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \*Categories 4, 5, and 6 are also described as critical limb ischemia.
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in Rutherford-Becker Classification From Pre-procedure | Improved | 108 Participants |
| DCB Subjects | Change in Rutherford-Becker Classification From Pre-procedure | No Change | 15 Participants |
| DCB Subjects | Change in Rutherford-Becker Classification From Pre-procedure | Worsened | 7 Participants |
| PTA Subjects | Change in Rutherford-Becker Classification From Pre-procedure | Improved | 63 Participants |
| PTA Subjects | Change in Rutherford-Becker Classification From Pre-procedure | Worsened | 2 Participants |
| PTA Subjects | Change in Rutherford-Becker Classification From Pre-procedure | No Change | 11 Participants |
Secondary
Change in Walking Distance From Pre-procedure
Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit.
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in Walking Distance From Pre-procedure | Improved | 77 Participants |
| DCB Subjects | Change in Walking Distance From Pre-procedure | No Change | 2 Participants |
| DCB Subjects | Change in Walking Distance From Pre-procedure | Worsened | 35 Participants |
| PTA Subjects | Change in Walking Distance From Pre-procedure | Improved | 47 Participants |
| PTA Subjects | Change in Walking Distance From Pre-procedure | No Change | 0 Participants |
| PTA Subjects | Change in Walking Distance From Pre-procedure | Worsened | 22 Participants |
Secondary
Change in Walking Distance From Pre-procedure
Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit.
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in Walking Distance From Pre-procedure | No Change | 1 Participants |
| DCB Subjects | Change in Walking Distance From Pre-procedure | Worsened | 49 Participants |
| DCB Subjects | Change in Walking Distance From Pre-procedure | Improved | 92 Participants |
| PTA Subjects | Change in Walking Distance From Pre-procedure | Improved | 57 Participants |
| PTA Subjects | Change in Walking Distance From Pre-procedure | No Change | 1 Participants |
| PTA Subjects | Change in Walking Distance From Pre-procedure | Worsened | 22 Participants |
Secondary
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | Improved | 98 Participants |
| DCB Subjects | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | No Change | 1 Participants |
| DCB Subjects | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | Worsened | 32 Participants |
| PTA Subjects | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | Improved | 50 Participants |
| PTA Subjects | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | No Change | 0 Participants |
| PTA Subjects | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | Worsened | 24 Participants |
Secondary
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DCB Subjects | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | Worsened | 39 Participants |
| DCB Subjects | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | Improved | 114 Participants |
| PTA Subjects | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | Improved | 63 Participants |
| PTA Subjects | Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure | Worsened | 19 Participants |
Secondary
Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 34 Participants |
| PTA Subjects | Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 22 Participants |
Secondary
Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 46 Participants |
| PTA Subjects | Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 27 Participants |
Secondary
Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 48 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 55 Participants |
| PTA Subjects | Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 33 Participants |
Secondary
Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 60 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 64 Participants |
| PTA Subjects | Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 37 Participants |
Secondary
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 48 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Mortality Rate | 27 Participants |
| PTA Subjects | Mortality Rate | 14 Participants |
Secondary
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 60 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Mortality Rate | 34 Participants |
| PTA Subjects | Mortality Rate | 19 Participants |
Secondary
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Mortality Rate | 13 Participants |
| PTA Subjects | Mortality Rate | 8 Participants |
Secondary
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Mortality Rate | 18 Participants |
| PTA Subjects | Mortality Rate | 10 Participants |
Secondary
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR | 65 Participants |
| PTA Subjects | Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR | 35 Participants |
Secondary
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR | 88 Participants |
| PTA Subjects | Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR | 45 Participants |
Secondary
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Clinically-driven Target Lesion Revascularization | 29 Participants |
| PTA Subjects | Rate of Clinically-driven Target Lesion Revascularization | 19 Participants |
Secondary
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 60 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Clinically-driven Target Lesion Revascularization | 51 Participants |
| PTA Subjects | Rate of Clinically-driven Target Lesion Revascularization | 29 Participants |
Secondary
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 48 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Clinically-driven Target Lesion Revascularization | 44 Participants |
| PTA Subjects | Rate of Clinically-driven Target Lesion Revascularization | 28 Participants |
Secondary
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Clinically-driven Target Lesion Revascularization | 38 Participants |
| PTA Subjects | Rate of Clinically-driven Target Lesion Revascularization | 24 Participants |
Secondary
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 60 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Clinically-driven Target Vessel Revascularization | 3 Participants |
| PTA Subjects | Rate of Clinically-driven Target Vessel Revascularization | 2 Participants |
Secondary
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 48 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Clinically-driven Target Vessel Revascularization | 3 Participants |
| PTA Subjects | Rate of Clinically-driven Target Vessel Revascularization | 2 Participants |
Secondary
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Clinically-driven Target Vessel Revascularization | 1 Participants |
| PTA Subjects | Rate of Clinically-driven Target Vessel Revascularization | 1 Participants |
Secondary
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Clinically-driven Target Vessel Revascularization | 3 Participants |
| PTA Subjects | Rate of Clinically-driven Target Vessel Revascularization | 1 Participants |
Secondary
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 48 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 4 Participants |
| PTA Subjects | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 0 Participants |
Secondary
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 60 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 4 Participants |
| PTA Subjects | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 0 Participants |
Secondary
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 3 Participants |
| PTA Subjects | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 0 Participants |
Secondary
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 4 Participants |
| PTA Subjects | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 0 Participants |
Secondary
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 60 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Target Lesion Revascularization | 55 Participants |
| PTA Subjects | Rate of Target Lesion Revascularization | 30 Participants |
Secondary
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 48 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Target Lesion Revascularization | 48 Participants |
| PTA Subjects | Rate of Target Lesion Revascularization | 29 Participants |
Secondary
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Target Lesion Revascularization | 42 Participants |
| PTA Subjects | Rate of Target Lesion Revascularization | 25 Participants |
Secondary
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Target Lesion Revascularization | 32 Participants |
| PTA Subjects | Rate of Target Lesion Revascularization | 20 Participants |
Secondary
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 24 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Target Limb Major Amputation | 1 Participants |
| PTA Subjects | Rate of Target Limb Major Amputation | 0 Participants |
Secondary
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 60 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Target Limb Major Amputation | 2 Participants |
| PTA Subjects | Rate of Target Limb Major Amputation | 0 Participants |
Secondary
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 36 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Target Limb Major Amputation | 1 Participants |
| PTA Subjects | Rate of Target Limb Major Amputation | 0 Participants |
Secondary
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 48 months post-procedure
Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCB Subjects | Rate of Target Limb Major Amputation | 2 Participants |
| PTA Subjects | Rate of Target Limb Major Amputation | 0 Participants |