ILLUMENATE Pivotal, CVI Drug-coated Balloon vs. Uncoated Balloon

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01858428
First received: May 8, 2013
Last updated: February 12, 2014
Last verified: February 2014

May 8, 2013
February 12, 2014
June 2013
July 2015   (final data collection date for primary outcome measure)
  • 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.
  • Patency at 12 months [ Time Frame: 12 months ]
    .
  • Major Adverse Events [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01858428 on ClinicalTrials.gov Archive Site
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ILLUMENATE Pivotal, CVI Drug-coated Balloon vs. Uncoated Balloon
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Peripheral Artery Disease
  • Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
  • Device: EverCross Percutaneous Transluminal Balloon Catheter
  • 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).
    Intervention: 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.
    Intervention: Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
Not Provided
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.

Exclusion Criteria:

  • Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated
Both
18 Years and older
No
United States
 
NCT01858428
TP-1397
Yes
Covidien
Covidien
Not Provided
Principal Investigator: Prakash Krishnan, MD Mt. Sinai Medical Center
Principal Investigator: Sean Lyden, MD The Cleveland Clinic
Covidien
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP