The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero drug-coated balloon \[DCB\]) in the treatment of the femoropopliteal artery lesions in patients with peripheral arterial disease (PAD). Specifically, the Randomized-Controlled Trial (RCT) is designed to demonstrate non-inferior safety and non-inferior effectiveness of the Evero DCB when compared to commercially available paclitaxel DCBs (pDCBs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
410
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
PTA with a DCB in de novo or restenotic lesions in native superficial femoral and popliteal arteries
Yale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGThe Cardiac and Vascular Institute
Gainesville, Florida, United States
RECRUITINGFirst Coast Cardiovascular Institute
Jacksonville, Florida, United States
RECRUITINGBaptist Cardiac and Vascular Institute
Miami, Florida, United States
RECRUITINGMidwest Cardiovascular Research Foundation
Davenport, Iowa, United States
RECRUITINGMcLaren Bay Region Hospital
Bay City, Michigan, United States
RECRUITINGNorth Mississippi Medical Center
Tupelo, Mississippi, United States
RECRUITINGCooper University Hospital
Camden, New Jersey, United States
RECRUITINGPrisma Health Memorial
Greenville, South Carolina, United States
RECRUITINGHouston Methodist Hospital
Houston, Texas, United States
RECRUITINGPrimary safety endpoint
The primary safety endpoint is a composite assessment of freedom from device- or procedure-related death, freedom from target limb major amputation, and freedom from clinically-driven target lesion revascularization (CD-TLR)
Time frame: 30 days (death); 12 months (amputation and CD-TLR)
Primary effectiveness endpoint
The primary effectiveness endpoint is primary patency defined as peak systolic velocity ratio ≤2.4 assessed by duplex ultrasound at 12 months and freedom from CD-TLR.
Time frame: 12 months
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