N/A
Completed N=1,189
LEVANT 2 Safety Registry
Peripheral Artery Disease · Femoropopliteal Artery Occlusion · Femoropopliteal Stenosis
Source: ClinicalTrials.gov NCT01790243 ↗
Enrolled (actual)
1,189
Serious AEs
78.9%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure. — 0; 0 Participants
Summary
The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Unanticipated Device- or Drug-Related Serious Adverse Events at 60 Months Post Index Procedure. |
0; 0 | — |
| SECONDARY Number of Subjects With Freedom From Death, Index-Limb Amputation, and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure |
1002; 155 | — |
| SECONDARY Number of Participants With All-Cause Perioperative (<30 Day) Death, Index Limb Amputation, Index Limb Re-intervention, and Index Limb Related Death at 1,6, 12, 24, 36, 48, and 60 Months Post Index Procedure |
1; 0; 8; 2; 18; 4 | — |
| SECONDARY Percentage of Participants With Primary Patency of the Target Lesion at 6, 12, and 24 Months Post Index Procedure |
81.4; 64.8; 66.3; 54.0; 54.5; 47.2 | — |
| SECONDARY Number of Acute Device Success at Time of Index Procedure |
1402; 180 | — |
| SECONDARY Number of Participants With Technical and Procedural Success |
894; 138; 892; 138 | — |
| SECONDARY Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 12, and 24 Months Post Index Procedure |
940; 144; 839; 122; 706; 104 | — |
| SECONDARY Number of Participants With Alternative Primary Patency at 6, 12, and 24 Months Post Index Procedure |
565; 74; 400; 62; 282; 38 | — |
| SECONDARY Improvement in Rutherford Classification Scores at 6, 12, and 24 Months Post Index Procedure Compared to Baseline |
830; 118; 79; 22; 35; 5 | — |
| SECONDARY Change in Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Compared to Baseline |
0.19; 0.16; 0.18; 0.18; 0.16; 0.17 | — |
Eligibility Criteria
Clinical Inclusion Criteria:
- Male or non-pregnant female ≥18 years of age;
- Rutherford Clinical Category 2-4;
- Patient is willing to provide informed consent, is geographically stable and comply with the required follow up visits, testing schedule and medication regimen;
Angiographic Lesion Inclusion Criteria:
- Length ≤15 cm;
- Up to two focal lesions or segments within the designated 15 cm length of vessel may be treated (e.g. two discrete segments, separated by several cm, but both falling within a composite length of 90 days from prior angioplasty procedure;
- Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
- Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix;
- Successful, uncomplicated (without use of a crossing device) antegrade 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); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.
- At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been revascularized (treatment of outflow disease is NOT permitted during the index procedure);
- Contralateral limb lesion(s) cannot be treated within 2 weeks before and/or planned 30 days after the protocol treatment in order to avoid confounding complications;
- No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.
Exclusion Criteria
Patients will be excluded if ANY of the following conditions apply:
- Pregnant or planning on becoming pregnant or men intending to father children;
- Life expectancy of 15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
- Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;
- Known inadequate distal outflow (>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
- Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
- Severe calcification that renders the lesion un-dilatable;
- Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).
Data sourced from ClinicalTrials.gov (NCT01790243). 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.