A Study to Evaluate How Safe and Effective is the Mixture of Lipiodol® Ultra Fluid and Glue When Used for Embolization Procedures

Guerbet

Status and phase: Completed; Phase 4

Conditions: Angiosarcoma; Hemangioendothelioma; Arteriovenous Malformations; Congenital Hemangioma

Treatments: Drug: Lipiodol Ultra Fluid with surgical glues

Study type: Interventional

Funder types: Industry

Identifiers

NCT02625389

LUF-44-001

CTRI/2017/05/008607 (Registry Identifier)

EUPAS15045 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Female or male adult subject older than 18 years,
2. Subject presenting with vascular lesions/anomalies whether malformative (arterial, venous, arteriovenous, fistula) or tumoral (benign: hemoangioma; malignant, angiosarcoma) eligible for vascular 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 vascular 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,
2. Subject with known contra-indications to vascular embolization (e.g. severe coagulation disorder, infectious syndrome),
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 than 2 days prior to vascular embolization as described in Lipiodol® Ultra Fluid SmPC,
7. Subject previously treated with Interleukin II as described in Lipiodol® Ultra Fluid SmPC,
8. Subject currently treated with effective anticoagulant therapy.
9. Pregnant or breast-feeding female subject,
10. Subject having received any IMP 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

Vascular embolization with Lipiodol Ultra Fluid and surgical glue

Experimental group

Description:

Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) was used in association with surgical glues. The glue was chosen according to the investigator and site practice and knowledge. The mixture ratio (Lipiodol Ultra Fluid/Glue) could vary from 20%/80% to 80%/20%. The volume of Lipiodol Ultra Fluid administered during the embolization procedure depended on lesion size but it should not exceed 15 mL.

Treatment:

Drug: Lipiodol Ultra Fluid with surgical glues