Critical Limb Ischemia, Peripheral Arterial Disease
Conditions
Brief summary
To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.
Sponsors
Medtronic Endovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Subject has been informed of the nature of the study, agrees to participate and has signed an EC approved consent form. 3. Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. 4. Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Clinical Category 4 or 5. 5. Subjects with documented infection grade 0-2 and ischemia grade 2-3 according to WIfi classification. 6. Life expectancy \>1 year in the Investigator's opinion. 7. Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment. 8. Total occlusions with total lesion length ≥ 40 mm (by visual estimate). 9. Lesion must be located in the infrapopliteal arteries and above the ankle joint. 10. Multiple lesions can be treated if located in separate vessels. 11. Presence of documented run-off to the foot. 12. Inflow free from flow-limiting lesion confirmed by angiography. 13. Successful pre-dilatation of the (entire) target lesion.
Exclusion criteria
1. Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study. 2. Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure. 3. Lesion and/or occlusions located or extending in the popliteal artery or below the ankle joint space. 4. Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries left untreated. 5. Failure to obtain ≤ 30% residual stenosis in pre-existing, hemodynamically significant inflow lesions in the ipsilateral iliac, SFA and popliteal artery. 6. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization. 7. Previous DCB procedure in the target vessel within 6 months prior to index procedure. 8. Aneurysm in the target vessel. 9. Angiographic evidence of thrombus within target limb. 10. Pre-dilatation resulted in major (≥ Grade D) flow-limiting dissection or residual stenosis \> 30%. 11. Use of alternative therapy e.g. atherectomy, cutting balloon, laser, radiation therapy, stents as part of target vessel treatment. 12. Recent MI or stroke \< 30 days prior to the index procedure. 13. Heart failure with Ejection Fraction \< 30%. 14. Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound on the target limb. 15. Subjects with infection grade 3 and ischemia grade 0 and 1 according to the Wifi classification. 16. Subjects with neutrotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk of major amputation. 17. Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement. 18. Impaired renal function (GFR \<20 mL/min) and patients on dialysis. 19. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment. 20. Patient receiving systemic corticosteroid therapy. 21. Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure. 22. The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study. 23. Female subjects who are breastfeeding at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months | 9 Months | Late lumen loss (LLL) - The difference between minimum lumen diameter (MLD) immediately after percutaneous balloon angioplasty PTA and MLD at follow up, measured at 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Event (MAE) Rate | through 3, 6, 9, 12, 24, 36, 48 and 60 months | defined as a composite of all-cause mortality, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) Reported by using the event-free survival Kaplan-Meier estimate through 60 months |
| Functional Flow Assessment | at 3, 6, 9, 12, 24 and 36 months | is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound. |
| Death of Any Cause | through 3, 6, 9, 12, 24, 36, 48 and 60 months | Death of any cause, reported by using the event-free survival Kaplan-Meier estimate through 60 months |
| Major Target Limb Amputation Rate | through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months | Major Target Limb Amputation rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months |
| Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | through 3, 6, 9, 12, 24, 36, 48 and 60 months | Clinically-driven Target Lesion Revascularization (CD-TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months |
| Mechanically-driven Target Lesion Revascularization (TLR) Rate | through 37 days | Mechanically-driven Target Lesion Revascularization (TLR) rate |
| Composite Safety Endpoint | 9 Months | A composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation and freedom from clinically-driven target lesion revascularization (CD-TLR) within 9 months post-index procedure |
| Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | through 3, 6, 9, 12, 24, 36, 48 and 60 months | Clinically-driven Target Vessel Revascularization (CD-TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months |
| Target Vessel Revascularization (TVR) Rate | through 3, 6, 9, 12, 24, 36, 48 and 60 months | Target Vessel Revascularization (TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months |
| Status of Wound Healing | at 30 days, 3, 6, 9, 12, 24 and 36 months | Status of wound healing for baseline wounds: completely healed - improvement - unchanged - worsened - Amputation - skin graft; percentage of wounds in each category is presented for each treatment arm |
| Rate of Thrombosis at the Target Lesion | through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months | Rate of thrombosis at the target lesion, reported by using the event-free survival Kaplan-Meier estimate through 60 months |
| Device Success | at the time of procedure | Calculated as the number of IN.PACT 014 Investigational devices with successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP), divided by the total number of IN.PACT 014 Investigational devices assessed in the study |
| Clinical Success | up to discharge visit [between index procedure and 30-day (+/- 7 days) follow-up visit. The average days until discharge was: 9 days (with a max. of 31days) in the IN.PACT 014 arm, and 6 days (with a max. of 21days) in the PTA arm.] | Clinical success is defined as residual stenosis of ≤ 30% without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)). If any lesion has residual stenosis \> 30% or any of the complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge, then subject is not counted as having Clinical Success. Clinical success is calculated as the number of index procedures with residual stenosis of ≤ 30% by core lab (use site reported data if core lab data is not available) for all target lesions and without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge as adjudicated by CEC, divided by the number of total index procedures performed. |
| Target Lesion Revascularization (TLR) Rate | through 3, 6, 9, 12, 24, 36, 48 and 60 months | Target Lesion Revascularization (TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months |
Countries
Belgium, France, Greece, Italy, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Drug Coated Balloon IN.PACT 014 Participants who receive IN.PACT 014 | 23 |
| Drug Coated Balloon IN.PACT 014 Participants who receive IN.PACT 014 | 25 |
| Percutaneous Transluminal Angioplasty (PTA) Participants who receive standard PTA treatment | 27 |
| Percutaneous Transluminal Angioplasty (PTA) Participants who receive standard PTA treatment | 30 |
| Total | 105 |
Baseline characteristics
| Characteristic | Percutaneous Transluminal Angioplasty (PTA) | Total | Drug Coated Balloon IN.PACT 014 |
|---|---|---|---|
| Age, Continuous | 69.6 Years STANDARD_DEVIATION 9.4 | 71.20 Years STANDARD_DEVIATION 8.6 | 73.1 Years STANDARD_DEVIATION 7.4 |
| Bilateral PAD | 14 Participants | 26 Participants | 12 Participants |
| Calcification | 12 Lesions | 25 Lesions | 13 Lesions |
| Calcification - mild/moderate | 4 Lesions | 7 Lesions | 3 Lesions |
| Calcification - moderate/severe | 4 Lesions | 12 Lesions | 8 Lesions |
| Calcification - severe | 4 Lesions | 6 Lesions | 2 Lesions |
| Cerebrovascular disease | 3 Participants | 9 Participants | 6 Participants |
| Congestive heart failure | 5 Participants | 7 Participants | 2 Participants |
| Current smoker | 3 Participants | 7 Participants | 4 Participants |
| Diabetes Mellitus | 26 Participants | 43 Participants | 17 Participants |
| Diabetes Mellitus Insulin-dependent | 20 Participants | 29 Participants | 9 Participants |
| Diameter Stenosis, % | 96.33 % STANDARD_DEVIATION 8.64 | 96.90 % STANDARD_DEVIATION 7.77 | 97.59 % STANDARD_DEVIATION 6.69 |
| End-stage renal disease | 0 Participants | 0 Participants | 0 Participants |
| Hyperlipideamia | 20 Participants | 36 Participants | 16 Participants |
| Hypertension | 21 Participants | 40 Participants | 19 Participants |
| Inflow in the target vessel (<30% residual stenosis) | 21 Participants | 39 Participants | 18 Participants |
| Ischaemic heart disease | 9 Participants | 19 Participants | 10 Participants |
| Lesion length | 218.19 mm STANDARD_DEVIATION 80.43 | 216.91 mm STANDARD_DEVIATION 81.2 | 215.41 mm STANDARD_DEVIATION 83.81 |
| Lesion type - De novo | 26 Lesions | 46 Lesions | 20 Lesions |
| Lesion type - Restenotic (non-stented) | 4 Lesions | 9 Lesions | 5 Lesions |
| Minimum lumen diameter, mm | 0.09 mm STANDARD_DEVIATION 0.21 | 0.08 mm STANDARD_DEVIATION 0.2 | 0.06 mm STANDARD_DEVIATION 0.19 |
| Obesity, BMI >=30kg/m2 | 7 Participants | 12 Participants | 5 Participants |
| Occluded lesion (site reported data) | 30 Lesions | 55 Lesions | 25 Lesions |
| Previous minor target limb amputation | 11 Participants | 14 Participants | 3 Participants |
| Previous peripheral revascularisation of target limb | 9 Participants | 16 Participants | 7 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Reference vessel diameter, mm | 2.71 mm STANDARD_DEVIATION 0.39 | 2.75 mm STANDARD_DEVIATION 0.46 | 2.80 mm STANDARD_DEVIATION 0.54 |
| Rutherford category 4 | 3 Participants | 6 Participants | 3 Participants |
| Rutherford category 5 | 24 Participants | 44 Participants | 20 Participants |
| Rutherford category 6 | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 4 Participants |
| Sex: Female, Male Male | 20 Participants | 39 Participants | 19 Participants |
| Target lesion location - Anterior tibial | 15 Lesions | 32 Lesions | 17 Lesions |
| Target lesion location - Peroneal | 2 Lesions | 3 Lesions | 1 Lesions |
| Target lesion location - Popliteal P3 segment | 1 Lesions | 3 Lesions | 2 Lesions |
| Target lesion location - posterior tibial | 12 Lesions | 18 Lesions | 6 Lesions |
| Target lesion location - Tibio-peroneal trunk | 4 Lesions | 8 Lesions | 4 Lesions |
| TASC II - A | 0 Lesions | 1 Lesions | 1 Lesions |
| TASC II - B | 4 Lesions | 5 Lesions | 1 Lesions |
| TASC II - C | 17 Lesions | 33 Lesions | 16 Lesions |
| TASC II - D | 8 Lesions | 14 Lesions | 6 Lesions |
| Total occluded lesion length, mm | 136.43 mm STANDARD_DEVIATION 72.82 | 147.45 mm STANDARD_DEVIATION 78.71 | 159.00 mm STANDARD_DEVIATION 84.66 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 23 | 9 / 27 |
| other Total, other adverse events | 13 / 23 | 24 / 27 |
| serious Total, serious adverse events | 19 / 23 | 25 / 27 |
Outcome results
Primary
Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months
Late lumen loss (LLL) - The difference between minimum lumen diameter (MLD) immediately after percutaneous balloon angioplasty PTA and MLD at follow up, measured at 9 months
Time frame: 9 Months
Population: 3 participants were missing data in IN.PACT 014 arm, and 3 participants were missing data in the PTA arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months | 0.892 mm | Standard Deviation 0.774 |
| Percutaneous Transluminal Angioplasty (PTA) | Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months | 1.312 mm | Standard Deviation 0.72 |
Secondary
Clinically-driven Target Lesion Revascularization (CD-TLR) Rate
Clinically-driven Target Lesion Revascularization (CD-TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
Population: number analyzed in one or more rows indicates the number analyzed at each timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 3 months | 95.45 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 6 months | 95.45 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 9 months | 90.68 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 12 months | 85.91 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 24 months | 80.86 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 36 months | 73.51 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 48 months | 73.51 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 60 months | 73.51 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 60 months | 69.78 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 3 months | 100.00 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 24 months | 79.75 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 6 months | 96.15 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 48 months | 69.78 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 9 months | 92.15 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 36 months | 79.75 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Through 12 months | 88.14 probability |
Secondary
Clinically-driven Target Vessel Revascularization (CD-TVR) Rate
Clinically-driven Target Vessel Revascularization (CD-TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
Population: number analyzed in one or more rows indicates the number analyzed at each timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 3 months | 95.45 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 6 months | 95.45 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 9 months | 90.68 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 12 months | 85.91 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 24 months | 80.86 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 36 months | 73.51 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 48 months | 73.51 probability |
| Drug Coated Balloon IN.PACT 014 | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 60 months | 73.51 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 60 months | 65.74 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 3 months | 96.15 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 24 months | 75.85 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 6 months | 92.31 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 48 months | 65.74 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 9 months | 88.29 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 36 months | 75.85 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Through 12 months | 84.28 probability |
Secondary
Clinical Success
Clinical success is defined as residual stenosis of ≤ 30% without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)). If any lesion has residual stenosis \> 30% or any of the complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge, then subject is not counted as having Clinical Success. Clinical success is calculated as the number of index procedures with residual stenosis of ≤ 30% by core lab (use site reported data if core lab data is not available) for all target lesions and without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge as adjudicated by CEC, divided by the number of total index procedures performed.
Time frame: up to discharge visit [between index procedure and 30-day (+/- 7 days) follow-up visit. The average days until discharge was: 9 days (with a max. of 31days) in the IN.PACT 014 arm, and 6 days (with a max. of 21days) in the PTA arm.]
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Clinical Success | 12 Participants |
| Percutaneous Transluminal Angioplasty (PTA) | Clinical Success | 11 Participants |
Secondary
Composite Safety Endpoint
A composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation and freedom from clinically-driven target lesion revascularization (CD-TLR) within 9 months post-index procedure
Time frame: 9 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Composite Safety Endpoint | 21 Participants |
| Percutaneous Transluminal Angioplasty (PTA) | Composite Safety Endpoint | 21 Participants |
Secondary
Death of Any Cause
Death of any cause, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
Population: number analyzed in one or more rows indicates the number analyzed at each timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Death of Any Cause | Through 3 months | 100.0 probability |
| Drug Coated Balloon IN.PACT 014 | Death of Any Cause | Through 6 months | 100.0 probability |
| Drug Coated Balloon IN.PACT 014 | Death of Any Cause | Through 9 months | 95.45 probability |
| Drug Coated Balloon IN.PACT 014 | Death of Any Cause | Through 12 months | 95.45 probability |
| Drug Coated Balloon IN.PACT 014 | Death of Any Cause | Through 24 months | 72.73 probability |
| Drug Coated Balloon IN.PACT 014 | Death of Any Cause | Through 36 months | 68.18 probability |
| Drug Coated Balloon IN.PACT 014 | Death of Any Cause | Through 48 months | 59.09 probability |
| Drug Coated Balloon IN.PACT 014 | Death of Any Cause | Through 60 months | 59.09 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Death of Any Cause | Through 60 months | 65.68 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Death of Any Cause | Through 3 months | 96.30 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Death of Any Cause | Through 24 months | 88.89 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Death of Any Cause | Through 6 months | 92.59 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Death of Any Cause | Through 48 months | 73.89 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Death of Any Cause | Through 9 months | 92.59 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Death of Any Cause | Through 36 months | 77.78 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Death of Any Cause | Through 12 months | 88.89 probability |
Secondary
Device Success
Calculated as the number of IN.PACT 014 Investigational devices with successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP), divided by the total number of IN.PACT 014 Investigational devices assessed in the study
Time frame: at the time of procedure
Population: 68 IN.PACT 014 Investigational devices used
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Device Success | 64 IN.PACT 014 Investigational devices |
Secondary
Functional Flow Assessment
is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound.
Time frame: at 3, 6, 9, 12, 24 and 36 months
Population: Participant analysis not performed, as this is a lesion-based measurement.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Functional Flow Assessment | At 3 Months | 15 Lesions |
| Drug Coated Balloon IN.PACT 014 | Functional Flow Assessment | At 6 Months | 15 Lesions |
| Drug Coated Balloon IN.PACT 014 | Functional Flow Assessment | At 9 Months | 11 Lesions |
| Drug Coated Balloon IN.PACT 014 | Functional Flow Assessment | At 12 Months | 11 Lesions |
| Drug Coated Balloon IN.PACT 014 | Functional Flow Assessment | At 24 Months | 6 Lesions |
| Drug Coated Balloon IN.PACT 014 | Functional Flow Assessment | At 36 Months | 9 Lesions |
| Percutaneous Transluminal Angioplasty (PTA) | Functional Flow Assessment | At 24 Months | 10 Lesions |
| Percutaneous Transluminal Angioplasty (PTA) | Functional Flow Assessment | At 3 Months | 14 Lesions |
| Percutaneous Transluminal Angioplasty (PTA) | Functional Flow Assessment | At 12 Months | 5 Lesions |
| Percutaneous Transluminal Angioplasty (PTA) | Functional Flow Assessment | At 6 Months | 13 Lesions |
| Percutaneous Transluminal Angioplasty (PTA) | Functional Flow Assessment | At 36 Months | 6 Lesions |
| Percutaneous Transluminal Angioplasty (PTA) | Functional Flow Assessment | At 9 Months | 6 Lesions |
Secondary
Major Adverse Event (MAE) Rate
defined as a composite of all-cause mortality, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) Reported by using the event-free survival Kaplan-Meier estimate through 60 months
Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
Population: number analyzed in one or more rows indicates the number analyzed at each timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Major Adverse Event (MAE) Rate | through 3 months | 95.45 probability |
| Drug Coated Balloon IN.PACT 014 | Major Adverse Event (MAE) Rate | through 6 months | 95.45 probability |
| Drug Coated Balloon IN.PACT 014 | Major Adverse Event (MAE) Rate | through 9 months | 86.36 probability |
| Drug Coated Balloon IN.PACT 014 | Major Adverse Event (MAE) Rate | through 12 months | 81.82 probability |
| Drug Coated Balloon IN.PACT 014 | Major Adverse Event (MAE) Rate | through 24 months | 54.55 probability |
| Drug Coated Balloon IN.PACT 014 | Major Adverse Event (MAE) Rate | through 36 months | 45.45 probability |
| Drug Coated Balloon IN.PACT 014 | Major Adverse Event (MAE) Rate | through 48 months | 45.45 probability |
| Drug Coated Balloon IN.PACT 014 | Major Adverse Event (MAE) Rate | through 60 months | 45.45 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Adverse Event (MAE) Rate | through 60 months | 46.89 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Adverse Event (MAE) Rate | through 3 months | 96.30 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Adverse Event (MAE) Rate | through 24 months | 70.37 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Adverse Event (MAE) Rate | through 6 months | 88.89 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Adverse Event (MAE) Rate | through 48 months | 51.16 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Adverse Event (MAE) Rate | through 9 months | 85.19 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Adverse Event (MAE) Rate | through 36 months | 62.96 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Adverse Event (MAE) Rate | through 12 months | 77.78 probability |
Secondary
Major Target Limb Amputation Rate
Major Target Limb Amputation rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Time frame: through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months
Population: number analyzed in one or more rows indicates the number analyzed at each timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Major Target Limb Amputation Rate | Through 3 months | 100.00 probability |
| Drug Coated Balloon IN.PACT 014 | Major Target Limb Amputation Rate | Through 24 months | 100.00 probability |
| Drug Coated Balloon IN.PACT 014 | Major Target Limb Amputation Rate | Through 9 months | 100.00 probability |
| Drug Coated Balloon IN.PACT 014 | Major Target Limb Amputation Rate | Through 36 months | 100.00 probability |
| Drug Coated Balloon IN.PACT 014 | Major Target Limb Amputation Rate | Through 6 months | 100.00 probability |
| Drug Coated Balloon IN.PACT 014 | Major Target Limb Amputation Rate | Through 48 months | 100.00 probability |
| Drug Coated Balloon IN.PACT 014 | Major Target Limb Amputation Rate | Through 12 months | 100.00 probability |
| Drug Coated Balloon IN.PACT 014 | Major Target Limb Amputation Rate | Through 60 months | 100.00 probability |
| Drug Coated Balloon IN.PACT 014 | Major Target Limb Amputation Rate | Through 30 days | 100.00 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Target Limb Amputation Rate | Through 60 months | 93.75 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Target Limb Amputation Rate | Through 30 days | 100.00 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Target Limb Amputation Rate | Through 3 months | 100.00 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Target Limb Amputation Rate | Through 6 months | 100.00 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Target Limb Amputation Rate | Through 9 months | 100.00 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Target Limb Amputation Rate | Through 12 months | 100.00 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Target Limb Amputation Rate | Through 24 months | 100.00 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Target Limb Amputation Rate | Through 36 months | 100.00 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Major Target Limb Amputation Rate | Through 48 months | 100.00 probability |
Secondary
Mechanically-driven Target Lesion Revascularization (TLR) Rate
Mechanically-driven Target Lesion Revascularization (TLR) rate
Time frame: through 37 days
Population: Number of subjects undergo MD-TLR within 37 days post-index procedure adjudicated by CEC divided by the number of evaluable subjects at 37 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Mechanically-driven Target Lesion Revascularization (TLR) Rate | 1 Participants |
| Percutaneous Transluminal Angioplasty (PTA) | Mechanically-driven Target Lesion Revascularization (TLR) Rate | 0 Participants |
Secondary
Rate of Thrombosis at the Target Lesion
Rate of thrombosis at the target lesion, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Time frame: through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months
Population: number analyzed in one or more rows indicates the number analyzed at each timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Rate of Thrombosis at the Target Lesion | Through 3 months | 95.7 probability |
| Drug Coated Balloon IN.PACT 014 | Rate of Thrombosis at the Target Lesion | Through 24 months | 86.1 probability |
| Drug Coated Balloon IN.PACT 014 | Rate of Thrombosis at the Target Lesion | Through 9 months | 95.7 probability |
| Drug Coated Balloon IN.PACT 014 | Rate of Thrombosis at the Target Lesion | Through 36 months | 86.1 probability |
| Drug Coated Balloon IN.PACT 014 | Rate of Thrombosis at the Target Lesion | Through 6 months | 95.7 probability |
| Drug Coated Balloon IN.PACT 014 | Rate of Thrombosis at the Target Lesion | Through 48 months | 86.1 probability |
| Drug Coated Balloon IN.PACT 014 | Rate of Thrombosis at the Target Lesion | Through 12 months | 90.9 probability |
| Drug Coated Balloon IN.PACT 014 | Rate of Thrombosis at the Target Lesion | Through 60 months | 86.1 probability |
| Drug Coated Balloon IN.PACT 014 | Rate of Thrombosis at the Target Lesion | Through 30 days | 95.7 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Rate of Thrombosis at the Target Lesion | Through 60 months | 96.3 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Rate of Thrombosis at the Target Lesion | Through 30 days | 96.3 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Rate of Thrombosis at the Target Lesion | Through 3 months | 96.3 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Rate of Thrombosis at the Target Lesion | Through 6 months | 96.3 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Rate of Thrombosis at the Target Lesion | Through 9 months | 96.3 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Rate of Thrombosis at the Target Lesion | Through 12 months | 96.3 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Rate of Thrombosis at the Target Lesion | Through 24 months | 96.3 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Rate of Thrombosis at the Target Lesion | Through 36 months | 96.3 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Rate of Thrombosis at the Target Lesion | Through 48 months | 96.3 probability |
Secondary
Status of Wound Healing
Status of wound healing for baseline wounds: completely healed - improvement - unchanged - worsened - Amputation - skin graft; percentage of wounds in each category is presented for each treatment arm
Time frame: at 30 days, 3, 6, 9, 12, 24 and 36 months
Population: This is a wound-based measurement. Numbers are % (counts/number of wounds with data).~Each participant could report one or more baseline wounds, or none. Therefore, the overall number of participants analyzed may not correspond to the number of wounds analyzed. Number of participants analyzed at each timepoint indicates the number of participants with at least one Baseline Wound.~21 wounds in the IN.PACT 014 arm, and 25 wounds were analyzed in the PTA arm, based on available data.
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 3 Months | Unchanged | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 30 Days | Completely Healed | 3 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 30 Days | Improvement | 7 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 30 Days | Unchanged | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 30 Days | Worsened | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 30 Days | Amputation | 11 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 30 Days | Skin graft | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 3 Months | Completely Healed | 5 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 3 Months | Improvement | 4 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 3 Months | Worsened | 1 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 3 Months | Amputation | 11 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 3 Months | Skin graft | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 6 Months | Completely Healed | 8 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 6 Months | Improvement | 2 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 6 Months | Unchanged | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 6 Months | Worsened | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 6 Months | Amputation | 11 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 6 Months | Skin graft | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 9 Months | Completely Healed | 9 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 9 Months | Improvement | 1 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 9 Months | Unchanged | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 9 Months | Worsened | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 9 Months | Amputation | 11 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 9 Months | Skin graft | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 12 Months | Completely Healed | 8 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 12 Months | Improvement | 1 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 12 Months | Unchanged | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 12 Months | Worsened | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 12 Months | Amputation | 11 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 12 Months | Skin graft | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 24 Months | Completely Healed | 8 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 24 Months | Improvement | 1 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 24 Months | Unchanged | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 24 Months | Worsened | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 24 Months | Amputation | 11 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 24 Months | Skin graft | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 36 Months | Completely Healed | 6 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 36 Months | Improvement | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 36 Months | Unchanged | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 36 Months | Worsened | 0 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 36 Months | Amputation | 7 Baseline wounds |
| Drug Coated Balloon IN.PACT 014 | Status of Wound Healing | Within 36 Months | Skin graft | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 36 Months | Completely Healed | 9 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 24 Months | Unchanged | 2 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 30 Days | Completely Healed | 2 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 9 Months | Worsened | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 30 Days | Improvement | 8 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 24 Months | Improvement | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 30 Days | Unchanged | 3 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 9 Months | Amputation | 11 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 30 Days | Worsened | 1 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 36 Months | Worsened | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 30 Days | Amputation | 11 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 9 Months | Skin graft | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 30 Days | Skin graft | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 36 Months | Improvement | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 3 Months | Completely Healed | 7 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 12 Months | Completely Healed | 10 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 3 Months | Improvement | 4 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 3 Months | Unchanged | 2 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 24 Months | Worsened | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 3 Months | Worsened | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 12 Months | Improvement | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 3 Months | Amputation | 11 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 36 Months | Skin graft | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 3 Months | Skin graft | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 12 Months | Unchanged | 2 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 6 Months | Completely Healed | 10 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 24 Months | Amputation | 11 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 6 Months | Improvement | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 12 Months | Worsened | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 6 Months | Unchanged | 1 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 36 Months | Unchanged | 2 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 6 Months | Worsened | 1 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 12 Months | Amputation | 11 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 6 Months | Amputation | 12 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 24 Months | Skin graft | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 6 Months | Skin graft | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 12 Months | Skin graft | 0 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 9 Months | Completely Healed | 10 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 36 Months | Amputation | 11 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 9 Months | Improvement | 1 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 24 Months | Completely Healed | 9 Baseline wounds |
| Percutaneous Transluminal Angioplasty (PTA) | Status of Wound Healing | Within 9 Months | Unchanged | 1 Baseline wounds |
Secondary
Target Lesion Revascularization (TLR) Rate
Target Lesion Revascularization (TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
Population: Number analyzed in one or more rows indicates the number analyzed at each timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Target Lesion Revascularization (TLR) Rate | Through 3 months | 95.65 probability |
| Drug Coated Balloon IN.PACT 014 | Target Lesion Revascularization (TLR) Rate | Through 6 months | 95.65 probability |
| Drug Coated Balloon IN.PACT 014 | Target Lesion Revascularization (TLR) Rate | Through 9 months | 90.87 probability |
| Drug Coated Balloon IN.PACT 014 | Target Lesion Revascularization (TLR) Rate | Through 12 months | 86.09 probability |
| Drug Coated Balloon IN.PACT 014 | Target Lesion Revascularization (TLR) Rate | Through 24 months | 81.02 probability |
| Drug Coated Balloon IN.PACT 014 | Target Lesion Revascularization (TLR) Rate | Through 36 months | 73.66 probability |
| Drug Coated Balloon IN.PACT 014 | Target Lesion Revascularization (TLR) Rate | Through 48 months | 73.66 probability |
| Drug Coated Balloon IN.PACT 014 | Target Lesion Revascularization (TLR) Rate | Through 60 months | 73.66 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Lesion Revascularization (TLR) Rate | Through 60 months | 62.13 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Lesion Revascularization (TLR) Rate | Through 3 months | 100.00 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Lesion Revascularization (TLR) Rate | Through 24 months | 71.69 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Lesion Revascularization (TLR) Rate | Through 6 months | 96.15 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Lesion Revascularization (TLR) Rate | Through 48 months | 62.13 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Lesion Revascularization (TLR) Rate | Through 9 months | 84.13 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Lesion Revascularization (TLR) Rate | Through 36 months | 71.69 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Lesion Revascularization (TLR) Rate | Through 12 months | 80.13 probability |
Secondary
Target Vessel Revascularization (TVR) Rate
Target Vessel Revascularization (TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months
Time frame: through 3, 6, 9, 12, 24, 36, 48 and 60 months
Population: number analyzed in one or more rows indicates the number analyzed at each timepoint
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 | Target Vessel Revascularization (TVR) Rate | Through 3 months | 95.65 probability |
| Drug Coated Balloon IN.PACT 014 | Target Vessel Revascularization (TVR) Rate | Through 6 months | 95.65 probability |
| Drug Coated Balloon IN.PACT 014 | Target Vessel Revascularization (TVR) Rate | Through 9 months | 90.87 probability |
| Drug Coated Balloon IN.PACT 014 | Target Vessel Revascularization (TVR) Rate | Through 12 months | 86.09 probability |
| Drug Coated Balloon IN.PACT 014 | Target Vessel Revascularization (TVR) Rate | Through 24 months | 81.02 probability |
| Drug Coated Balloon IN.PACT 014 | Target Vessel Revascularization (TVR) Rate | Through 36 months | 73.66 probability |
| Drug Coated Balloon IN.PACT 014 | Target Vessel Revascularization (TVR) Rate | Through 48 months | 73.66 probability |
| Drug Coated Balloon IN.PACT 014 | Target Vessel Revascularization (TVR) Rate | Through 60 months | 73.66 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Vessel Revascularization (TVR) Rate | Through 60 months | 58.10 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Vessel Revascularization (TVR) Rate | Through 3 months | 96.15 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Vessel Revascularization (TVR) Rate | Through 24 months | 67.78 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Vessel Revascularization (TVR) Rate | Through 6 months | 92.31 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Vessel Revascularization (TVR) Rate | Through 48 months | 58.10 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Vessel Revascularization (TVR) Rate | Through 9 months | 80.27 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Vessel Revascularization (TVR) Rate | Through 36 months | 67.78 probability |
| Percutaneous Transluminal Angioplasty (PTA) | Target Vessel Revascularization (TVR) Rate | Through 12 months | 76.25 probability |