Evaluation of Lipiodol and glues during vascular procedure.
- Conditions
- Health Condition 1: T818- Other complications of procedures,not elsewhere classified
- Registration Number
- CTRI/2017/05/008607
- Lead Sponsor
- GUERBET
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
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: hemangioma; 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
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, presence of portal thrombosis)
3. Subject whose lesion(s) to be embolized is/are acutely bleeding
4. Subject presenting with 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 subjectâ??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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber and percentage of subjects experiencing Adverse Drugs Reactions (ADRs) after each administration of Lipiodol® Ultra Fluid in association with surgical glues until leaving the catheterization laboratoryTimepoint: Adverse Reactions of Lipiodol® Ultra Fluid in association with <br/ ><br>surgical glues during the first session (Day-01) of Vascular embolization (until the patient leaves the catheterization room) <br/ ><br>
- Secondary Outcome Measures
Name Time Method -ADR occurring from the first administration of mixture until the end of followup <br/ ><br>-AEs <br/ ><br>-Target and post-procedure obliteration per lesion will be evaluated respectively before the first procedure and after each procedure according to 4 level score:1.less than 50;2.50-75;3.75-99;and 4.100(Percentage)corresponding to a complete nidus obliteration rate <br/ ><br>-Successful lesions embolization expressed as the lesions achieving the targeted percentage of obliterationTimepoint: 1. Adverse drug reactions up to 7 days follow-up after the first vascular embolization session <br/ ><br>2. Adverse events up to 7 days follow-up after the first vascular embolization session <br/ ><br>3. Successful lesions obliteration at the end of the 1st session of embolization