ILLUMENATE Pivotal, CVI Drug-coated Balloon vs. Uncoated Balloon
This study is designed to demonstrate safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter to treat peripheral arterial disease. There are two hypotheses being tested. 1) The drug-coated PTA catheter is as safe as the PTA catheter without drug and 2)The drug-coated PTA catheter is more effective than the catheter without drug.
Peripheral Artery Disease
Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Device: EverCross Percutaneous Transluminal Balloon Catheter
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon|
- Patency at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]Patency at 12 months 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.
- Freedom from device and procedure-related death through 30 days, TLR 12 months post procedure. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Bare PTA
The control device is a CE-marked, commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien/ev3® Incorporated, Plymouth, MN 55441, USA).
|Device: EverCross Percutaneous Transluminal Balloon Catheter|
Experimental: drug-coated PTA
The CVI Paclitaxel-coated PTA Catheter (CV Ingenuity Corporation/Covidien, Fremont, CA, 94555 USA) is a CE-marked, commercially available PTA balloon catheter (EverCross® 0.035" PTA Balloon Catheter, Covidien/ev3®, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.
|Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter|
|United States, Florida|
|The Cardiac and Vascular Institute||Recruiting|
|Gainesville, Florida, United States, 32605|
|Contact: Matheen Khuddus, MD 352-331-8570|
|Principal Investigator: Matheen Khuddus, MD|
|Sub-Investigator: Arthur Lee, MD|
|Sub-Investigator: Daniel Van Roy, MD|
|Principal Investigator:||Prakash Krishnan, MD||Mt. Sinai Medical Center|
|Principal Investigator:||Sean Lyden, MD||The Cleveland Clinic|