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Trial record 1 of 1 for:    NCT03413852
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Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent (CHOICE) (CHOICE)

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ClinicalTrials.gov Identifier: NCT03413852
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Embo-Flüssigkeiten A.G.

Brief Summary:
The objective of this study is to further establish that SQUID, an alternative liquid embolic agent with specific properties, is a safe and effective alternative in bAVM endovascular treatment strategy available to date. Therefore, the performance of SQUID will be documented and its safety of use will be confirmed in current practice.

Condition or disease Intervention/treatment
Cerebral Arteriovenous Malformation Device: SQUID non-adhesive liquid embolic agent

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 111 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Treatment of Cerebral Arteriovenous Malformations With SQUID Liquid Embolic Agent - The CHOICE Study A Non-interventional, Prospective, Single-arm, International, Multicenter Study
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2021



Intervention Details:
  • Device: SQUID non-adhesive liquid embolic agent
    AVM embolization using SQUID non-adhesive liquid embolic agent


Primary Outcome Measures :
  1. modified Rankin Score (mRS) [ Time Frame: 3 to 6 months after the last embolisation session ]

    mRS is a scale used to measure the degree of handicap or dependence in daily activities of people who have suffered a stroke or other causes of neurological handicap.

    The scale ranges from 0 to 6, running from perfect health, without symptoms, to death.

    0 - No symptoms

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Death.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients planned for embolization using SQUID to achieve occlusion of a previously untreated bAVM.
Criteria

Inclusion Criteria:

  • Patient planned for one or multiple embolization sessions using SQUID to achieve occlusion of a previously untreated bAVM.*

    *Patients with a direct fistula or saccular/flow-related aneurysm previously treated with NBCA and/or coils may be included.

  • Patient in whom the use of SQUID had been decided for an embolization alone or in association to neurosurgery or radiotherapy.
  • Patient ≥18 years old.
  • Patient or authorized representative dully informed and having no objection to the clinical data collection and medical file access. An informed consent form must be signed and dated whenever required by local legislation

Exclusion Criteria:

  • Patient with bAVM not eligible for endovascular treatment.
  • Patient with bAVM previously treated by embolization with other devices (Liquid embolic agent, NBCA, particles, and coils).*

    *Patients with a direct fistula or saccular / flow-related aneurysm previously treated with NBCA and/or coils may be included.

  • Patient with bAVM previously treated with surgery or radiotherapy.
  • Patient intended to undergo surgery and embolization during the same procedure at first embolization
  • Patient with multiple bAVM or bAVM associated with dural arteriovenous Fistula*.

    *Patients with a direct fistula or saccular / flow-related aneurysm previously treated with NBCA and/or coils may be included.

  • Patient presenting contra-indication to the use of SQUID according to the Instructions For Use.
  • Intention to treat with any non-adhesive embolic liquid other than SQUID, or planned treatment with another non-adhesive embolic liquid over the course of the endovascular treatment phase.
  • Patient planned for a total endovascular treatment phase duration exceeding 2 years.
  • Patient participating in another clinical study evaluating another medical device, another procedure or a medication.
  • Any condition or any situation that would prohibit the patient from coming to the investigational center for the follow-up as recommended by the study protocol between 3 and 6 months, or prohibit carrying out the telephone mRS assessments at 1 month after each embolization session and at 12 months after the end of the endovascular treatment phase.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413852


Contacts
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Contact: Laure Coutrot +33130106863 laure.coutrot@balt.fr

Locations
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Belgium
University Hospital Antwerp Recruiting
Edegem, Belgium
Contact: Maurits Voormolen, Pr. Dr.         
Denmark
Odense University Hospital Recruiting
Odense, Denmark
Contact: Gyula Gal, Dr.         
France
CHU Bordeaux Recruiting
Bordeaux, France
Contact: Xavier Barreau, Dr.         
CHU Brest Recruiting
Brest, France
Contact: Jean-Christophe Gentric, Dr.         
Hospices Civils de Lyon Recruiting
Bron, France
Contact: Francis Turjman, Prof.         
CHU Bicêtre Recruiting
Le Kremlin-Bicêtre, France
Contact: Laurent Spelle, Prof.         
Hôpital Central Recruiting
Nancy, France, 54000
Contact: Serge Bracard, Prof.         
Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Emmanuel Houdart, Prof.         
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Michel Piotin, Dr.         
Hôpital Maison Blanche Active, not recruiting
Reims, France, 51000
CHU Rouen Recruiting
Rouen, France
Contact: Chrisanthi Papagiannaki, Dr.         
CHU de Saint-Etienne Recruiting
Saint-Étienne, France, 42000
Contact: Mohamed Aggour, Dr.         
CHU Toulouse Active, not recruiting
Toulouse, France
Germany
Zentralklinikum Augsburg Not yet recruiting
Augsburg, Germany
Contact: Ansgar Berlis, Pr. Dr. med.         
Klinikum der Ruhr-Universität Bochum, Knappschaftskrankenhaus Not yet recruiting
Bochum, Germany
Contact: Werner Weber, Pr. Dr. med.         
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Stephan Meckel, Prof. Dr. med.         
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany
Contact: Markus Möhlenbruch, Dr. med.         
Klinikum Grosshadern Not yet recruiting
Munich, Germany
Contact: Franziska Dorn, Dr. med.         
Italy
San Gerardo Monza Not yet recruiting
Monza, Italy
Contact: Luca Valvassori, Dr.         
Sponsors and Collaborators
Embo-Flüssigkeiten A.G.

Additional Information:

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Responsible Party: Embo-Flüssigkeiten A.G.
ClinicalTrials.gov Identifier: NCT03413852     History of Changes
Other Study ID Numbers: CIP-201701-SQUID
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma
Intracranial Arteriovenous Malformations
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases