Peripheral artery disease can reduce blood flow to the legs. In some patients, the superficial femoral artery, a major artery in the thigh, is completely blocked over a long segment. This study will evaluate a minimally invasive treatment for these blockages.
Approximately 60 adults who require endovascular treatment will undergo placement of a filter beyond the blockage to collect debris. Rotational atherectomy will then be used to remove part of the material causing the blockage, followed by drug-coated balloon angioplasty to widen the artery. A stent may be placed only if needed because of an inadequate treatment result or a procedure-related complication.
Participants will be evaluated by clinical examination and duplex ultrasound at 1, 3, 6, and 12 months. The main goal is to determine how often the treated artery remains open at 12 months. The study will also evaluate technical success, the need for repeat treatment, material captured by the filter, and procedure-related blockage of smaller downstream arteries.
Age 18 years or older Symptomatic peripheral artery disease classified as Rutherford category 2 to 5 Chronic total occlusion of the superficial femoral artery extending from its origin toward Hunter's canal Clinical indication for endovascular treatment At least one patent distal runoff artery
Acute limb ischemia Severe renal impairment contraindicating iodinated contrast administration Coagulopathy Absence of a patent distal runoff artery
Single group
Rotational Atherectomy With Distal Embolic Protection and Drug-Coated Balloon Angioplasty
DeviceAfter successful crossing of the superficial femoral artery chronic total occlusion, a distal embolic protection filter will be deployed in the distal superficial femoral or popliteal artery. Rotational atherectomy will be performed to debulk atherosclerotic and thrombotic material, followed by drug-coated balloon angioplasty. Bailout stenting may be performed for flow-limiting dissection, significant residual stenosis, or another inadequate angiographic result.
Primary Patency of the Treated Superficial Femoral Artery Segment at 12 Months
The proportion of participants with a patent treated superficial femoral artery segment on duplex ultrasonography, defined as a peak systolic velocity ratio of less than 2.4.
Primary Patency of the Treated Superficial Femoral Artery Segment at 1, 3, and 6 Months
The proportion of participants with a patent treated superficial femoral artery segment at each scheduled follow-up, assessed by duplex ultrasonography and defined as a peak systolic velocity ratio of less than 2.4.
Target Lesion Revascularization
The proportion of participants requiring repeat endovascular or surgical revascularization of the treated SFA segment.
Periprocedural Distal Embolization
The proportion of participants with clinically evident or angiographically confirmed distal embolization associated with the index procedure.
Macroscopic Material Captured in the Distal Embolic Protection Filter
The proportion of retrieved distal embolic protection filters containing macroscopically visible thrombotic or atheromatous debris.
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