Peripheral Arterial Disease
Conditions
Brief summary
This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.
Detailed description
The ILLUMENATE Pivotal study is a prospective, randomized, multi-center, single-blind study which will include up to 360 subjects in approximately forty-five (45) sites across the United States to evaluate the CVI Paclitaxel-coated PTA Catheter compared to the bare percutaneous transluminal angioplasty balloon catheter (bare balloon catheter) for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
Interventions
DEVICECardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.
DEVICEEverCross Percutaneous Transluminal Balloon Catheter
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).
Sponsors
Spectranetics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.
Exclusion criteria
* Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency at 12 Month Post-procedure | 12 months | 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. |
| Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization | 30 Days and 12 months | 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 12 months post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Clinically-driven Target Lesion Revascularization | 6, 12, 24, 36, 48 and 60 months | — |
| Rate of Target Lesion Revascularization | 6, 12, 24, 36, 48 and 60 months | — |
| Rate of Target Limb Major Amputation | 1, 6, 12, 24, 36, 48 and 60 months | — |
| Mortality Rate | 6, 12, 24, 36, 48 and 60 months | — |
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 1, 6, 12, 24, 36, 48 and 60 months | — |
| Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure | 1, 6, 12, 24, 36, 48 and 60 months | Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). |
| Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% | procedure, Day 0 | Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion. |
| Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% | procedure, Day 0 | Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion. |
| Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure | procedure, Day 0 | Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure. |
| Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure | procedure, Day 0 | Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure. |
| Change in Ankle-brachial Index (ABI) From Pre-procedure | 6, 12, 24 and 36 months | Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period. |
| Patency Rate and Freedom From Clinically-driven TLR | 6, 24 and 36 months | Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months |
| Rate of Vascular Access and Bleeding Complications | in-hospital and 1, 6, 12 and 24 months | Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months. |
Countries
Austria, United States
Participant flow
Pre-assignment details
Randomization. Patients who provided written informed consent but were excluded from the study due to not meeting all of the inclusion criteria or meeting one or more of the exclusion criteria were screen failures. Subjects who had unsuccessful pre-dilatation were not randomized and were to be treated per the institution's standard of care.
Participants by arm
| Arm | Count |
|---|---|
| Bare PTA EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic) | 100 |
| Drug-Coated PTA Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier. | 200 |
| Total | 300 |
Baseline characteristics
| Characteristic | Bare PTA | Total | Drug-Coated PTA |
|---|---|---|---|
| Age, Customized Age | 69.8 years STANDARD_DEVIATION 9.8 | 68.8 years STANDARD_DEVIATION 10.1 | 68.3 years STANDARD_DEVIATION 10.3 |
| Ankle-Brachial Index | 0.76 ratio STANDARD_DEVIATION 0.2 | 0.75 ratio STANDARD_DEVIATION 0.21 | 0.75 ratio STANDARD_DEVIATION 0.21 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 19 Participants | 54 Participants | 35 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 17 Participants | 9 Participants |
| Race/Ethnicity, Customized White | 68 Participants | 210 Participants | 142 Participants |
| Region of Enrollment Austria | 10 participants | 27 participants | 17 participants |
| Region of Enrollment United States | 90 participants | 273 participants | 183 participants |
| Rutherford Becker Clinical Category Rutherford 2 | 35 participants | 98 participants | 63 participants |
| Rutherford Becker Clinical Category Rutherford 3 | 60 participants | 189 participants | 129 participants |
| Rutherford Becker Clinical Category Rutherford 4 | 5 participants | 13 participants | 8 participants |
| Sex: Female, Male Female | 36 Participants | 124 Participants | 88 Participants |
| Sex: Female, Male Male | 64 Participants | 176 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 100 | 5 / 200 |
| other Total, other adverse events | 85 / 100 | 162 / 200 |
| serious Total, serious adverse events | 63 / 100 | 120 / 200 |
Outcome results
Primary
Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization
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 12 months post-procedure.
Time frame: 30 Days and 12 months
Population: Some Safety Status Missing at 12 Months Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have had a primary safety event within 12 months prior to study exit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bare PTA | Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization | 79 Participants |
| Drug-Coated PTA | Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization | 174 Participants |
Primary
Patency at 12 Month 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: 12 months
Population: Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have been eligible for failures carried forward or had a Clinically driven target lesion revasc (CD-TLR) prior to study exit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bare PTA | Patency at 12 Month Post-procedure | 53 Participants |
| Drug-Coated PTA | Patency at 12 Month Post-procedure | 135 Participants |
Secondary
Change in Ankle-brachial Index (ABI) From Pre-procedure
Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.
Time frame: 6, 12, 24 and 36 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bare PTA | Change in Ankle-brachial Index (ABI) From Pre-procedure | 69 Participants |
| Drug-Coated PTA | Change in Ankle-brachial Index (ABI) From Pre-procedure | 132 Participants |
Secondary
Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion.
Time frame: procedure, Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bare PTA | Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% | 98 participants |
| Drug-Coated PTA | Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% | 196 participants |
Secondary
Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure
Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 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: 1, 6, 12, 24, 36, 48 and 60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bare PTA | Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure | 17 Events |
| Drug-Coated PTA | Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure | 18 Events |
Secondary
Mortality Rate
Time frame: 6, 12, 24, 36, 48 and 60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bare PTA | Mortality Rate | 2 participants |
| Drug-Coated PTA | Mortality Rate | 5 participants |
Secondary
Patency Rate 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 at 6, 24 and 36 months
Time frame: 6, 24 and 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bare PTA | Patency Rate and Freedom From Clinically-driven TLR | 58 participants |
| Drug-Coated PTA | Patency Rate and Freedom From Clinically-driven TLR | 133 participants |
Secondary
Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure
Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.
Time frame: procedure, Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bare PTA | Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure | 98 participants |
| Drug-Coated PTA | Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure | 196 participants |
Secondary
Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure
Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.
Time frame: procedure, Day 0
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bare PTA | Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure | 98 Participants |
| Drug-Coated PTA | Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure | 196 Participants |
Secondary
Rate of Clinically-driven Target Lesion Revascularization
Time frame: 6, 12, 24, 36, 48 and 60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bare PTA | Rate of Clinically-driven Target Lesion Revascularization | 15 participants |
| Drug-Coated PTA | Rate of Clinically-driven Target Lesion Revascularization | 16 participants |
Secondary
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Time frame: 1, 6, 12, 24, 36, 48 and 60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bare PTA | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 0 participants |
| Drug-Coated PTA | Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 2 participants |
Secondary
Rate of Target Lesion Revascularization
Time frame: 6, 12, 24, 36, 48 and 60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bare PTA | Rate of Target Lesion Revascularization | 17 participants |
| Drug-Coated PTA | Rate of Target Lesion Revascularization | 18 participants |
Secondary
Rate of Target Limb Major Amputation
Time frame: 1, 6, 12, 24, 36, 48 and 60 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bare PTA | Rate of Target Limb Major Amputation | 0 participants |
| Drug-Coated PTA | Rate of Target Limb Major Amputation | 0 participants |
Secondary
Rate of Vascular Access and Bleeding Complications
Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.
Time frame: in-hospital and 1, 6, 12 and 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bare PTA | Rate of Vascular Access and Bleeding Complications | 3 participants |
| Drug-Coated PTA | Rate of Vascular Access and Bleeding Complications | 8 participants |
Secondary
Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion.
Time frame: procedure, Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bare PTA | Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% | 98 Lesion |
| Drug-Coated PTA | Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% | 196 Lesion |