The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length. Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions \>140 mm and ≤ 190 mm in length.
Atherosclerosis is a systemic disease that has become increasingly recognized in the expanding elderly population as a significant cause of morbidity and mortality. Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms ranging from intermittent claudication to ischemic rest pain and critical ischemia with major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully treat with endovascular therapy because the disease is often diffuse and located in an area of the body subject to significant mobility stresses such as extension, contraction, compression, elongation, flexion and torsion. The IMPERIAL trial is a global, prospective, multi-center trial. Approximately 525-535 subjects will be enrolled at up to 75 study centers worldwide. Regions participating include the United States, Canada, European Union, Japan and New Zealand. The trial consists of a prospective, multicenter, 2:1 randomized (ELUVIA vs Zilver PTX), controlled, single-blind, non-inferiority trial (RCT), a concurrent, non-blinded, non-randomized, single-arm, pharmacokinetic (PK) substudy and a concurrent, non-blinded, non-randomized, Long Lesion substudy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
524
Drug-eluting self-expanding stent implantation during the index procedure.
Drug-eluting self-expanding stent implantation during the index procedure.
Percentage of Participants With Major Adverse Events (MAEs)
MAEs defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization (TLR) through 12 months
Time frame: 12 Months
Number of Participants Reaching Primary Patency
Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory
Time frame: 12 Months
Number of CEC-adjudicated Events Through 12 Months
Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window.
Time frame: 12 Months
Count of Participants Meeting Primary Sustained Clinical Improvement
Defined as improvement in Rutherford classification (defined as chronic, symptomatic lower limb ischemia in categories 2, 3 or 4) by one or more categories compared with baseline, without target lesion revascularization.
Time frame: 12 Months
Number of Participants With Hemodynamic Improvement
Defined as an increase in the ankle-brachial index by greater than of equal to 0.10 compared with baseline or to an ankle-brachial index of greater than or equal to 0.90, without need for repeat target lesion revascularization.
Time frame: 12 Months
Walking Impairment Questionnaire (WIQ) Scores
The WIQ is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. WIQ scores reported as change from baseline.
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Yuma Regional Medical Center
Yuma, Arizona, United States
University of California, Davis Medical Center
Sacramento, California, United States
Florida Research Network, LLC
Gainesville, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
MediQuest Research at Munroe Regional Medical Center
Ocala, Florida, United States
Baptist Hospital
Pensacola, Florida, United States
University Hospital
Augusta, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
...and 58 more locations
Time frame: Baseline to 12 Months
6-Minute Walk Test - Distance Walked
Change in distance walked from baseline to 12 months.
Time frame: Change in baseline to 12-Months
6-Minute Walk Test - Speed
Change in speed walked from baseline to 12 months
Time frame: Baseline to 12 months