Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Global Study of a Drug-coated Balloon to Treat Obstructive SFA and/or Popliteal Lesions

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01927068
First received: July 25, 2013
Last updated: February 12, 2014
Last verified: February 2014

July 25, 2013
February 12, 2014
July 2013
May 2015   (final data collection date for primary outcome measure)
  • Primary Safety Endpoint [ Time Frame: Through 30 days post-procedure. ] [ 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 (TLR) through 12 months post-procedure.
  • Primary Efficacy Endpoint [ Time Frame: 12 months post-procedure. ] [ Designated as safety issue: No ]
    Primary patency at 12 months post-procedure. Primary patency is defined as the absence of target lesion restenosis per duplex ultrasound (peak systolic velocity ratio [PSVR] ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
Same as current
Complete list of historical versions of study NCT01927068 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Global Study of a Drug-coated Balloon to Treat Obstructive SFA and/or Popliteal Lesions
ILLUMENATE GLOBAL: Prospective, Single-Arm, Global Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery and/or Popliteal Lesions With a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

Single-Arm, multicenter study to continue to assess the safety and performance of the CVI Paclitaxel-Coated PTA Balloon Catheter in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Peripheral Arterial Disease
Device: CVI Paclitaxel-Coated PTA Balloon Catheter
Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
Experimental: CVI Paclitaxel-Coated PTA Balloon Catheter
Intervention: Device: CVI Paclitaxel-Coated PTA Balloon Catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
500
May 2017
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Has clinically significant symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery.
  2. Has a Rutherford Clinical Category of 2 - 4. Note: Rutherford Clinical Category 2-3 subjects should be entered into the study if conservative treatment has been unsuccessful.
  3. Is at least 18 years old.
  4. Has life expectancy > 1 year.
  5. Is able and willing to provide written informed consent prior to study-specific procedures.
  6. Is willing and capable of complying with the required follow-up visits, testing schedule and medication regimen.

Angiographic Inclusion Criteria

  1. Has evidence at the target lesion(s) of clinically and hemodynamically significant de novo stenosis or restenosis, or occlusion, in the SFA (1 cm distal to the ostium of the profunda) and/or popliteal artery, confirmed by angiography.
  2. Has target limb with at least one patent (<50% stenosis) tibio-peroneal run-off vessel to the foot confirmed by baseline angiography or magnetic resonance angiography (MRA) or computed tomography angiography (CTA). Note: Treatment of outflow disease is NOT permitted.
  3. Has 1 or 2 target lesion(s) with a cumulative length of no more than 20 cm.
  4. Has target lesion(s) located >2 cm from any stent if the target vessel was previously stented.
  5. Has a reference vessel diameter of 4 - 6 mm.
  6. Has a successful exchangeable guidewire crossing of the lesion(s).

Exclusion Criteria:

  1. Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing.
  2. Has significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
  3. Has known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
  4. Is currently participating in another investigational device or drug study that would interfere with study endpoints.
  5. Has history of hemorrhagic stroke within 3 months.
  6. Has surgical or endovascular procedure of the target limb within 14 days prior to the index procedure.
  7. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
  8. Has had a previous peripheral bypass affecting the target limb.
  9. Has unstable angina pectoris, myocardial infarction, liver failure, renal failure or chronic kidney disease within 30 days of the index procedure.

Angiographic Exclusion Criteria

  1. Has significant stenosis (≥ 50%) or occlusion of inflow tract that is not successfully revascularized (< 30% residual stenosis without death or major vascular complication) prior to treatment of the target lesion(s). Treatment of target lesion(s) is acceptable after successful treatment of inflow artery lesion(s).
  2. Has an acute or sub-acute intraluminal thrombus within the target vessel.
  3. Has in-stent restenosis or restenosis of the target lesion following previous treatment with a drug-coated balloon.
  4. Has an aneurysmal target vessel.
  5. Has perforation, dissection or other injury of the access or target vessel requiring stenting or surgical intervention prior to enrollment.
  6. Has no normal arterial segment proximal to the target lesion in which duplex ultrasound velocity ratios can be measured.
  7. Requires use of adjunctive therapies (i.e., laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy).
  8. Has severe calcification that precludes adequate PTA treatment.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   New Zealand
 
NCT01927068
CP-1005, CP-1005
Not Provided
Covidien
Covidien
Not Provided
Principal Investigator: Thomas Zeller, MD Herz-Zentrum Bad Krozingen, Germany
Principal Investigator: Andrew Holden, MD Auckland Hospital, New Zealand
Principal Investigator: Yann Goueffic, MD Hopital Nord Laennec
Principal Investigator: Carlos Mena, MD Yale University
Covidien
February 2014

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