The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.
This first-in-human study will evaluate the safety and effectiveness of a novel adjunctive therapy, SBCV, used with balloon angioplasty as compared to balloon angioplasty plus a control agent (saline) when used for the treatment of stenosis within the femoropopliteal artery. Effectiveness will be measured by late lumen loss at 24 weeks post treatment as evaluated by an independent, blinded core lab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
Royal Prince Alfred Hospital
Melbourne, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Flinders Medical Center
Adelaide, South Australia, Australia
Incidence of treatment-emergent adverse events
The composite of no all-cause perioperative (≤30 day) mortality and none of the following events at 24 weeks following treatment: * Index limb amputation (above or below the ankle) * Index limb re-intervention * Index-limb-related death
Time frame: through 24 weeks
Late Lumen Loss
LLL is defined as the difference between the minimum lumen diameter (MLD) immediately post-primary procedure and the MLD at follow-up as measured by an independent, blinded core lab.
Time frame: 24 weeks
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Austin Health
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Auckland City Hospital
Auckland, New Zealand