Global Study of a Drug-coated Balloon to Treat Obstructive SFA and/or Popliteal Lesions (ILLUMENATE)
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|ClinicalTrials.gov Identifier: NCT01927068|
Recruitment Status : Recruiting
First Posted : August 22, 2013
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: CVI Paclitaxel-Coated PTA Balloon Catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||501 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ILLUMENATE GLOBAL and ISR: Prospective, Single-Arm, Global Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery (SFA) and/or Popliteal Lesions With a Novel Paclitaxel-Coated Percutaneous Angioplasty (PTA) Balloon and in In-Stent Restenosis|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||November 2018|
|Experimental: CVI Paclitaxel-Coated PTA Balloon Catheter||
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.
Other Name: Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)
- Primary Safety Endpoint [ Time Frame: Through 30 days post-procedure. ]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. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927068
|Contact: Karen Krygier, MBAfirstname.lastname@example.org|
Show 39 Study Locations
|Principal Investigator:||Thomas Zeller, MBChB, FRANZCR||Herz-Zentrum Bad Krozingen, Germany|
|Principal Investigator:||Andrew Holden, MD||Auckland Hospital, New Zealand|
|Principal Investigator:||Yann Goueffic, MD||Hopital Nord Laennec, France|