Phase 2
Completed N=101
LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis
Atherosclerosis · Vascular Disease · Arteriosclerosis
Source: ClinicalTrials.gov NCT00930813 ↗
Enrolled (actual)
101
Serious AEs
77.2%
Results posted
Dec 2015
Primary outcomePrimary: Angiographic Late Lumen Loss — 0.46; 1.09 mm — p=0.016
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Angiographic Late Lumen Loss |
0.46; 1.09 | 0.016 sig |
| SECONDARY Safety - Device Related Adverse Events |
0; 4 | — |
| SECONDARY Primary Patency of Treated Segment |
— | — |
| SECONDARY Target Lesion Revascularization |
— | — |
| SECONDARY Target Vessel Revascularization |
— | — |
| SECONDARY Device Success |
— | — |
| SECONDARY Procedural Success |
— | — |
| SECONDARY Change in Ankle-brachial Index |
— | — |
| SECONDARY Change in Walking Impairment Questionnaire (WIQ) |
— | — |
| SECONDARY Change in Rutherford Grade |
— | — |
| SECONDARY Serum Paclitaxel Levels - in Subsets of Patients |
— | — |
Eligibility Criteria
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 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 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
Data sourced from ClinicalTrials.gov (NCT00930813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.