ILLUMENATE.

Trial name or title	Pivotal Trial of a Novel Paclitaxel‐Coated Percutaneous Angioplasty Balloon
Methods	Randomized controlled trial
Participants	Country: USA and Austria Setting: 44 hospitals and endovascular centers Number of participants: 360 Inclusion criteria: Age > 18 years Symptomatic leg ischemia, requiring treatment of the SFA or PA Exclusion criteria: Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pretreated
Interventions	Uncoated balloon angioplasty device: EverCross catheter DEB device: Cardiovascular Ingenuity (CVI) catheter Vessels treated: femoropopliteal vessels
Outcomes	Primary: Patency at 12 months postprocedure, defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically driven TLR Freedom from device and procedure‐related death through 30 days postprocedure and freedom from target limb major amputation and clinically driven TLR through 12 months postprocedure Secondary: MAE rate in the hospital and at 1, 6, 12, 24, 36, 48, and 60 months postprocedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically driven TLR Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12, and 24 months Rate of clinically driven TLR at 6, 12, 24, 36, 48, and 60 months Rate of TLR at 6, 12, 24, 36, 48, and 60 months Rate of target limb major amputation at 1, 6, 12, 24, 36, 48, and 60 months Mortality rate at 6, 12, 24, 36, 48, and 60 months Rate of occurrence of arterial thrombosis of the treated segment at 1, 6, 12, 24, 36, 48, and 60 months Patency rate and freedom from clinically driven TLR at 6, 24, and 36 months Lesion success, defined as achievement of a final inlesion residual diameter stenosis of ≤ 50% (as determined by the angiographic core lab), using any device after wire passage through the lesion Technical success, defined as achievement of a final inlesion residual diameter stenosis of ≤ 50% (as determined by the angiographic core lab), using the CVI Paclitaxel‐coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion Clinical success (per participant) defined as technical success without the occurrence of MAEs during the procedure Procedural success (per participant) defined as lesion success without the occurrence of MAEs during the procedure Change in ABI from preprocedure at 6, 12, 24, and 36 months Change in WIQ from preprocedure at 6, 12, 24, and 36 months Change in Rutherford‐Becker classification of chronic limb ischemia from preprocedure at 6, 12, 24, and 36 months Change in EQ‐5D from preprocedure at 6, 12, 24, and 36 months
Starting date	June 2013
Contact information	Dr Prakash Krishnan, prakash.krishnan@mssm.edu Dr Sean Lyden, lydens@ccf.org
Notes	Sponsor: Spectranetics Corporation