This clinical trial will evaluate the study device, Passeo®-18 Lux® paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of new or recurring cholesterol-related blockages in the arteries of the lower leg.
The device that is used in this trial has been assessed in several previous studies for safety and effectiveness. The device is already approved for use in Europe. It has a "CE mark," which means it meets the European Union's safety, health and performance standards.
This trial is being done to gather additional information on how well the device works and how safe it is when used in everyday medical care with specific attention to the longer lengths of the balloon, as it comes in different sizes.
Study participant is ≥ 18 years and ≤ 99 years old
Lesion above the knee (ATK): Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
Lesion below the knee (BTK): Target lesions involve arteries below the tibial plateau
RVD 2-7mm
Life expectancy ≤ 1 year
Study participant is currently participating in another investigational drug or device study that has not reached its primary endpoint yet.
Study participant is pregnant, planning to become pregnant, or father children during the course of the study.
Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion).
Single group
Percutaneous Transluminal Angioplasty with the use of Passeo-18 Lux DCB
Procedure/SurgeryThis intervention uses the Passeo-18 Lux paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of new or recurring cholesterol-related blockages in the arteries of the lower leg.
Freedom from clinically-driven target lesion revascularization (fcd-TLR) within 12 months post-index procedure.
The primary clinical performance endpoint is Freedom from clinically-driven target lesion revascularization (fcd-TLR) within 12 months post-index procedure.
Freedom from Major Adverse Events (MAE) through 12 months
The primary safety endpoint is freedom from major adverse events (MAE), defined as a composite of freedom from device- or procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven TLR, within 12 months post-index procedure.
Successful delivery, inflation, deflation, and retrieval of the intact study device during index procedure.
Device success is defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without burst below rated burst pressure.
Restoration of target lesion with ≤30% residual stenosis in final angiogram.
Procedural success is defined as restoration of the target lesion with ≤30% residual stenosis in the final angiogram.
Number of deaths from any cause (all-cause mortality) at 1, 6, 12, 24, 36, 48, and 60 months
All-cause mortality is defined as the total number of deaths from any cause among study participants at each scheduled follow-up time point.
Primary patency of target lesion (freedom from clinically driven target lesion revascularization [fcd-TLR] and binary restenosis)
Primary patency is defined as a composite of freedom from clinically driven target lesion revascularization (fcd-TLR) and binary restenosis, where restenosis is defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis as assessed by an independent DUS core lab.
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