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New combo for blocking blood vessels shows safety in rare vascular conditions

NCT ID NCT02625389

Disease control Sponsor: Guerbet Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the safety of using Lipiodol® Ultra Fluid (a contrast dye) together with surgical glues to block abnormal blood vessels in 132 adults with conditions like hemangiomas or arteriovenous malformations. The procedure was done as part of their regular treatment plan. Researchers tracked side effects during the procedure and for one month after, and also checked how well the vessels were blocked.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

132 people

The number who actually took part.

Started

Nov 2017

Finished

May 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

angiosarcoma arteriovenous hemangioma/malformation arteriovenous malformations of the brain congenital hemangioma hemangioendothelioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Angiosarcoma Arteriovenous malformations Congenital hemangioma Hemangioendothelioma

Contacts and locations

Locations

  • 7 Orange Hospitals

    Pune, 411033, India

  • AIIMS

    Jodhpur, 342005, India

  • AIIMS

    New Delhi, 110029, India

  • Acharya Vinobha Bhave Hospital

    Wardha, 442004, India

  • Apollo Hospital

    Hyderabad, 500096, India

  • B.J Govt College & Sassoon Hospitals

    Pune, 411001, India

  • BLK Super Speciality Hospital

    New Delhi, 110005, India

  • Division of Peripheral Vascular & Endovascular sciences, Medanta-The Medicity Hospital

    Gurgaon, Haryana, 122001, India

  • Geetanjali Medical College and Hospital

    Udaipur, 313002, India

  • Government Medical College

    Nagpur, 440009, India

  • KEM Hospital

    Pune, 411011, India

  • KLES Dr. Prabhakar Kore Hospital

    Belagavi, 590010, India

  • Mahatma Gandhi Missions Medical college and Hospital

    Aurangabad, 431003, India

  • Mazumdar Shaw medical Centre

    Bengaluru, 560099, India

  • Sanjay Gandhi Post Graduate Institute of Meducal Sciences (SGPGI)

    Lucknow, 226014, India

  • Victoria Hospital

    Bengaluru, 560002, India

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