Angiosarcoma, Arteriovenous Malformations, Congenital Hemangioma, Hemangioendothelioma
Conditions
Brief summary
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.
Interventions
DRUGLipiodol Ultra Fluid with surgical glues
Lipiodol Ultra Fluid and surgical glue mixture administered via selective arterial catheterization.
Sponsors
Guerbet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Drug Reactions During the Embolization Procedure | Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Drug Reactions up to One Month After the Embolization Procedure | Collected between laboratory discharge and up to one month post-procedure | — |
| Adverse Events up to One Month After the Embolization Procedure | Collected up to one month post-procedure | — |
| Number of Lesions With an Actual Obliteration Score Equal to or Higher Than the Target Score | Assessed on earliest available angiogram after the procedure (up to 30 days after the procedure) | 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% |
Countries
India
Participant flow
Pre-assignment details
Among the 132 included subjects, 124 received the Lipiodol Ultra Fluid and surgical glue mixture and were analyzed for safety and efficacy
Participants by arm
| Arm | Count |
|---|---|
| Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue Included patients who were eligible for an embolization procedure with Lipiodol Ultra Fluid (Ethyl esters of iodized fatty acids of poppy seed oil) in association with surgical glues. | 124 |
| Total | 124 |
Baseline characteristics
| Characteristic | Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue | — |
|---|---|---|
| Age, Continuous | 34.2 years STANDARD_DEVIATION 13.6 | — |
| Body Mass Index | 21.93 kg/m^2 STANDARD_DEVIATION 3.49 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment India | 124 Participants | — |
| Sex: Female, Male Female | 69 Participants | — |
| Sex: Female, Male Male | 55 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 124 |
| other Total, other adverse events | 23 / 124 |
| serious Total, serious adverse events | 2 / 124 |
Outcome results
Primary
Adverse Drug Reactions During the Embolization Procedure
Time frame: Collected between administration of the mixture and catheterization laboratory discharge (up to 1 day)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue | Adverse Drug Reactions During the Embolization Procedure | 0 Participants |
Secondary
Adverse Drug Reactions up to One Month After the Embolization Procedure
Time frame: Collected between laboratory discharge and up to one month post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue | Adverse Drug Reactions up to One Month After the Embolization Procedure | 1 Participants |
Secondary
Adverse Events up to One Month After the Embolization Procedure
Time frame: Collected up to one month post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue | Adverse Events up to One Month After the Embolization Procedure | 23 Participants |
Secondary
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)
Population: The total number of lesions treated was 138, but the actual obliteration rate was not reported for 3 lesions.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Vascular Embolization With Lipiodol Ultra Fluid and Surgical Glue | Number of Lesions With an Actual Obliteration Score Equal to or Higher Than the Target Score | 119 Lesions |
| Second Embolization Procedure | Number of Lesions With an Actual Obliteration Score Equal to or Higher Than the Target Score | 11 Lesions |