Clinical trial NCT02625389: Evaluation of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization.
Official title: Safety and Efficacy of Lipiodol® Ultra Fluid in Association With Surgical Glues During Vascular Embolization. A Phase IV Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Congenital Hemangioma
Hemangioendothelioma
Angiosarcoma
Arteriovenous Malformation
Keywords: scheduled for selective transarterial catheterization
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2015-12-09
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is multicenter (up to 10 sites in India) 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.


Eligibility criteria: 1. Female or male adult subject older than 18 years
2. Subject presenting with vascular lesions/anomalies whether malformative or tumoral eligible for endovascular embolization of single or multiple lesion(s), using selective transarterial catheterization and Lipiodol® Ultra Fluid in association with surgical glues as only embolization material, in the next stage of the therapeutic or palliative strategy
3. Subject not previously treated for this/those lesion(s) by endovascular embolization using Lipiodol® Ultra Fluid in association with surgical glues
4. Subject able and willing to participate to the study
5. Subject having read the information, having consented to audio-visual recording of informed consent process and having provided his/her consent to participate in writing by dating and signing the informed consent form or subject unable to consent in writing whose free and voluntary consent is confirmed in writing by a legal representative or impartial witness, prior to any study related procedure being conducted

Non inclusion criteria :

1. Subject scheduled for vascular embolization using embolization materials and radiopaque material other than Lipiodol® Ultra Fluid in association with surgical glues (e.g. embolizing fluids such as alcohol or sclerosant agents; particles; implants such as coils or microcoils or balloons; powdered metals such as tantalum or tungsten), whether in combination or alone, during the study catheterization procedure
2. Subject with known contra-indications to vascular embolization (e.g. presence of portal thrombosis)
3. Subject for whom lesion(s) to be embolized is/are acutely bleeding
4. Subject presenting life-threatening emergency situation
5. Subject with known contra-indication(s) to the use or with known sensitivity to Lipiodol® Ultra Fluid, to its ingredients or to drugs from a similar pharmaceutical class
6. Subject currently treated with beta-blockers, metformin or subject who stopped beta-blockers, metformin less that 2 days prior to vascular embolization as described in Lipiodol® Ultra Fluid Summary of Product Characteristics
7. Subject previously treated with Interleukin II as described in Lipiodol® Ultra Fluid Summary of Product Characteristics
8. Subject currently treated with effective anticoagulant therapy
9. Pregnant or breast-feeding female subject
10. Subject having received any investigational medicinal product within 7 days prior to enrolment
11. Subject with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the subject's safety or her/his ability to participate to the study
12. Subject unlikely to comply with the protocol, e.g. uncooperative attitude, and unlikely to complete the study
13. Subject related to the Investigator or any other study staff or relative directly involved in the study conduct

Primary outcomes:
measure: Adverse drug reactions during any session of embolization
timeFrame: at the time patient leaving the catheterization room (Day 0)
Secondary outcomes:
measure: Adverse drug reactions up to one month follow-up
timeFrame: Collected at follow-up up to one month follow-up
measure: Adverse events up to one month follow-up
timeFrame: Collected at follow-up up to one month follow-up
measure: Obliteration rate
timeFrame: at angiogram after the first session of embolization (Day 0)
Other outcomes:
Locations:
city: Gurgaon
country: India
facility: Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital
state: Haryana
city: Vellore
country: India
facility: Christian Medical College Hospital
state: Tamil Nadu
Study officials:
affiliation: Guerbet
name: Pierre DESCHE, MD
role: STUDY_CHAIR
References: