Atherosclerosis, Vascular Disease, Arteriosclerosis
Conditions
Keywords
Drug coated balloon, SFA disease, Femoropopliteal disease, Angioplasty, PAD, Paclitaxel, Tubulin modulators, Antineoplastic Agents, Mitosis Modulators, Balloon angioplasty, Local drug delivery, Restenosis, Drug-coated balloon
Brief summary
The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.
Detailed description
The LEVANT I trial will enroll patients presenting with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the femoropopliteal arteries. Patients will be randomized to treatment with either the Lutonix Catheter or standard balloon angioplasty after predilation.
Interventions
DEVICELutonix Catheter
Paclitaxel Coated Balloon Catheter
plain, uncoated angioplasty balloon catheter
Sponsors
C. R. Bard
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
Clinical Criteria * Male or non-pregnant female ≥18 years of age. * Rutherford Clinical Category 2-5 * Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen Angiographic Criteria * A single de novo or restenotic atherosclerotic lesion \>70% in the SFA or popliteal artery that is ≥4 cm and ≤15 cm in total length. * Reference vessel diameter ≥4 mm and ≤ 6mm * Successful wire crossing of lesion * A patent inflow artery free from significant lesion (\>50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions)
Exclusion criteria
* Pregnant or planning on becoming pregnant in \< 2yrs * Live expectancy of \<2 years * Patient actively participating in another investigational device or drug study * History of hemorrhagic stroke within 3 months * Previous or planned surgical or interventional procedure within 30 days of index procedure * Chronic renal insufficiency with creatinine \>2.5 mg/L * Prior surgery of the target lesion * Inability to take required study medications * Anticipated use of IIb/IIIa inhibitor prior to randomization * Lesion length is \<4 cm or \>15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured * Known inadequate distal outflow * Significant inflow disease * Acute or sub-acute thrombus in target vessel * Severe lesion calcification * Acute vessel occlusion or sudden symptom onset * Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.) * Prior participation in the current study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic Late Lumen Loss | 6 months | Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency of Treated Segment | 6, 12, 24 months | — |
| Target Lesion Revascularization | 6, 12, 24 months | — |
| Target Vessel Revascularization | 6, 12, 24 months | — |
| Device Success | at procedure | Successful delivery and deployment of the first inserted study device (in overlapping setting a successful delivery and deployment of the first and second study device) at the intended target lesion and successful withdrawal of the study device with attainment of final residual stenosis of less than 30% of the target lesion by quantitative vessel angiography (QVA). |
| Safety - Device Related Adverse Events | 30 days | — |
| Change in Ankle-brachial Index | pre-procedure, 6, 12 and 24 months | — |
| Change in Walking Impairment Questionnaire (WIQ) | pre-procedure, 6, 12 and 24 months | — |
| Change in Rutherford Grade | pre-procedure,6, 12 and 24 months | — |
| Serum Paclitaxel Levels - in Subsets of Patients | 0, 1, 3 hours and pre-discharge | — |
| Procedural Success | at procedure | Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary) |
Countries
Belgium, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lutonix Catheter Paclitaxel coated Balloon Catheter
Lutonix Catheter: Paclitaxel Coated Balloon Catheter | 49 |
| Standard Uncoated Balloon Angioplasty Catheter uncoated angioplasty balloon
Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter | 52 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 5 |
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | Lutonix Catheter | Standard Uncoated Balloon Angioplasty Catheter | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 8 | 70 years STANDARD_DEVIATION 10 | 68 years STANDARD_DEVIATION 9 |
| Lesion Length | 81 mm STANDARD_DEVIATION 37 | 80 mm STANDARD_DEVIATION 38 | 81 mm STANDARD_DEVIATION 38 |
| Lesion location Popliteal | 4 participants | 3 participants | 7 participants |
| Lesion location SFA | 45 participants | 49 participants | 94 participants |
| Lesion totally occluded No | 29 participants | 30 participants | 59 participants |
| Lesion totally occluded Yes | 20 participants | 22 participants | 42 participants |
| Rutherford Class 2 (Moderate claudication) | 11 participants | 11 participants | 22 participants |
| Rutherford Class 3 (Severe claudication) | 35 participants | 37 participants | 72 participants |
| Rutherford Class 4 (Ischemia rest pain) | 1 participants | 2 participants | 3 participants |
| Rutherford Class 5 (Minor tissue loss) | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 15 Participants | 22 Participants | 37 Participants |
| Sex: Female, Male Male | 34 Participants | 30 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 49 | 28 / 52 |
| serious Total, serious adverse events | 39 / 49 | 39 / 52 |
Outcome results
Primary
Angiographic Late Lumen Loss
Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months.
Time frame: 6 months
Population: Intent-to-treat among completers, including all patients with valid angiographic imaging analyzable by the core lab.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lutonix DCB Catheter | Angiographic Late Lumen Loss | 0.46 mm | Standard Deviation 1.13 |
| Standard Uncoated PTA Catheter | Angiographic Late Lumen Loss | 1.09 mm | Standard Deviation 1.07 |
Comparison: The study required 100 subjects to provide 80% power to detect a clinically meaningful difference in late lumen loss of 15% of reference vessel diameter between treatment groups on the basis of a 2-sample Student t test with 2-sided alpha 0.05.p-value: 0.016t-test, 2 sided
Secondary
Change in Ankle-brachial Index
Time frame: pre-procedure, 6, 12 and 24 months
Secondary
Change in Rutherford Grade
Time frame: pre-procedure,6, 12 and 24 months
Secondary
Change in Walking Impairment Questionnaire (WIQ)
Time frame: pre-procedure, 6, 12 and 24 months
Secondary
Device Success
Successful delivery and deployment of the first inserted study device (in overlapping setting a successful delivery and deployment of the first and second study device) at the intended target lesion and successful withdrawal of the study device with attainment of final residual stenosis of less than 30% of the target lesion by quantitative vessel angiography (QVA).
Time frame: at procedure
Secondary
Primary Patency of Treated Segment
Time frame: 6, 12, 24 months
Secondary
Procedural Success
Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)
Time frame: at procedure
Secondary
Safety - Device Related Adverse Events
Time frame: 30 days
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lutonix DCB Catheter | Safety - Device Related Adverse Events | 0 participants |
| Standard Uncoated PTA Catheter | Safety - Device Related Adverse Events | 4 participants |
Secondary
Serum Paclitaxel Levels - in Subsets of Patients
Time frame: 0, 1, 3 hours and pre-discharge
Secondary
Target Lesion Revascularization
Time frame: 6, 12, 24 months
Secondary
Target Vessel Revascularization
Time frame: 6, 12, 24 months