This was a multicenter phase IV Post-Marketing Study. The study is designed to investigate the safety of Lipiodol® Ultra Fluid in association with surgical glues used according to each site medical practice of vascular embolization. Subjects will be enrolled with the main condition that a procedure of vascular embolization using Lipiodol® Ultra Fluid in association with surgical glues is part of their therapeutic/palliative strategy for their disease. The vascular embolization using Lipiodol® Ultra Fluid in association with surgical glue will be administered as study procedure. According to the patient need and health status a second vascular embolization using Lipiodol® Ultra Fluid in association with surgical glue may be considered by the investigator within the next 30 days after the first one. In this case, this procedure will be considered as a second study procedure. The per-procedure safety evaluation will be enabled by appropriate records of safety events during the time frame of the procedure of vascular embolization using Lipiodol® Ultra Fluid in association with surgical glues. Safety evaluation will be completed with safety records within 30 +/-3 days after the embolization procedure. Efficacy evaluation will rely on the level of lesion(s) obliteration after embolization compared to the pre-procedural target level of obliteration. Exploratory descriptive statistical methods will be used to evaluate safety and efficacy, using both the total population and subsets of subjects with similar clinical conditions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Lipiodol Ultra Fluid and surgical glue mixture administered via selective arterial catheterization.
Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital
Gurgaon, Haryana, India
Mahatma Gandhi Missions Medical college and Hospital
Aurangabad, India
KLES Dr. Prabhakar Kore Hospital
Belagavi, India
Victoria Hospital
Bengaluru, India
Mazumdar Shaw medical Centre
Bengaluru, India
Apollo Hospital
Hyderabad, India
AIIMS
Jodhpur, India
Sanjay Gandhi Post Graduate Institute of Meducal Sciences (SGPGI)
Lucknow, India
Government Medical College
Nagpur, India
BLK Super Speciality Hospital
New Delhi, India
...and 6 more locations
Adverse Drug Reactions During the Embolization Procedure
Time frame: Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day)
Adverse Drug Reactions up to One Month After the Embolization Procedure
Time frame: Collected between laboratory discharge and up to one month post-procedure
Adverse Events up to One Month After the Embolization Procedure
Time frame: Collected up to one month post-procedure
Number of Lesions With an Actual Obliteration Score Equal to or Higher Than the Target Score
Level of obliteration of the vascular bed of a lesion is evaluated in percentage (%) and distributed in a 4-level score : (1) \<50%, (2) 50-75%, (3) 75-99%, and (4) 100%
Time frame: Assessed on earliest available angiogram after the procedure (up to 30 days after the procedure)
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