This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.
The ILLUMENATE Pivotal study is a prospective, randomized, multi-center, single-blind study which will include up to 360 subjects in approximately forty-five (45) sites across the United States to evaluate the CVI Paclitaxel-coated PTA Catheter compared to the bare percutaneous transluminal angioplasty balloon catheter (bare balloon catheter) for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
300
The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).
Patency at 12 Month Post-procedure
Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
Time frame: 12 months
Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization
Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure.
Time frame: 30 Days and 12 months
Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure
Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 1, 6, 12, 24, 36, 48 and 60 months
Rate of Vascular Access and Bleeding Complications
Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.
Time frame: in-hospital and 1, 6, 12 and 24 months
Rate of Clinically-driven Target Lesion Revascularization
Time frame: 6, 12, 24, 36, 48 and 60 months
Rate of Target Lesion Revascularization
Time frame: 6, 12, 24, 36, 48 and 60 months
Rate of Target Limb Major Amputation
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Yuma Regional Medical Center
Yuma, Arizona, United States
Mission Cardiovascular Research Institute
Fremont, California, United States
Good Samaritan Hospital - Los Angeles
Los Angeles, California, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Cardiovascular Research of North Florida
Gainesville, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Coastal Vascular and Interventional
Pensacola, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
...and 34 more locations
Time frame: 1, 6, 12, 24, 36, 48 and 60 months
Mortality Rate
Time frame: 6, 12, 24, 36, 48 and 60 months
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Time frame: 1, 6, 12, 24, 36, 48 and 60 months
Patency Rate and Freedom From Clinically-driven TLR
Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months
Time frame: 6, 24 and 36 months
Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion.
Time frame: procedure, Day 0
Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%
Technical success, defined as achievement of a final in-lesion 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.
Time frame: procedure, Day 0
Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure
Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.
Time frame: procedure, Day 0
Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure
Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.
Time frame: procedure, Day 0
Change in Ankle-brachial Index (ABI) From Pre-procedure
Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.
Time frame: 6, 12, 24 and 36 months