Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

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.

Condition Intervention Phase
Peripheral Artery Disease
Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Device: EverCross Percutaneous Transluminal Balloon Catheter
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Covidien:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 360
Study Start Date: June 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01858428

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         
Sponsors and Collaborators
Principal Investigator: Prakash Krishnan, MD Mt. Sinai Medical Center
Principal Investigator: Sean Lyden, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Covidien Identifier: NCT01858428     History of Changes
Other Study ID Numbers: TP-1397
Study First Received: May 8, 2013
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on March 01, 2015