Table 1.
Inclusion and Exclusion Criteria
| Inclusion criteria | Exclusion criteria |
|---|---|
| • Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery | • Pregnant or lactating females |
| • Male or nonpregnant female > 18 years of age | • Coexisting clinically significant aneurismal disease of the abdominal aorta, iliac, or popliteal arteries |
| • De novo or restenotic lesion(s) >70% stenosed within the SFA and popliteal (P 1 segment) arteries in a single limb | • Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of antiplatelet therapy |
| • ≥3 cm and ≤15 cm in cumulative length (by visual estimation) | • Known or intolerance to study medications, paclitaxel, or contrast agents |
| • Subject is willing to provide informed consent and comply with the required follow‐up visits, testing schedule, and medication regimen | • Doubts in the willingness or capability of the subject to allow follow‐up examinations |
| • Successful wire crossing of lesion | • Subject actively participating in another investigational device or drug study |
| • Target vessel reference diameter ≥3 and ≤7 mm (by visual estimation) | • History of hemorrhagic stroke within 3 months |
| • Target lesion(s) can be treated with a maximum of two DCBs | • Previous or planned surgical or interventional procedure within 30 days of the index procedure |
| • At least one patency (<50% stenosis) tibio‐peroneal run‐off vessel confirmed by baseline angiography or prior Magnetic resonance angiography or CT angiography | • Prior vascular surgery of the target lesion |
| • Lesion length <3 cm or >15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured | |
| • Life expectancy < 1 year | • Known inadequate distal outflow |
| • Rutherford classification of 2, 3, or 4 | • Significant inflow disease |
| • Acute or subacute thrombus in target vessel | |
| • Use of adjunctive therapies (i.e., laser, atherectomy, cryoplasty, scoring/cutting balloons, and brachytherapy) | |
| • Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥50% stenosis) may not be treated during the same procedure | |
| • Presence of prohibitive calcification that precludes adequate PTA treatment | |
| • Subjects held in custody in an institution or official or court order |