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Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

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ClinicalTrials.gov Identifier: NCT02602990
Recruitment Status : Active, not recruiting
First Posted : November 11, 2015
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
Archer Research
Information provided by (Responsible Party):
Emboflu

Brief Summary:
A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.

Condition or disease Intervention/treatment
Cerebral Arteriovenous Malformations Device: SQUID™

Detailed Description:

This observational study will collect data about the treatment of ruptured, unruptured, untreated or endovascular previously treated AVM's.

Primary endpoint is safety. Safety will be assessed with the number of procedure-related complications occurring during the endovascular treatment until 30 days after the final embolization.

Secondary endpoint is efficacy. Efficacy will be assessed by angiography and clinical outcome assessments (mRS).

For each patient enrolled, data will be collected at inclusion, at each embolization session and at 6 ± 1 months after the end of the endovascular treatment phase.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent
Actual Study Start Date : August 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018


Group/Cohort Intervention/treatment
Cerebral AVM treated with SQUID™ Device: SQUID™



Primary Outcome Measures :
  1. Incidence of complications / adverse events (Safety) [ Time Frame: From the start of the procedure until 30 days after procedure ]
    The safety is assessed with the number of procedure-related complications occurring during endovascular treatment until 30 days after the final embolization session. Procedure-related complications include complications/adverse events related to the procedure or to the device such as but not limited to hemorrhagic and ischemic complications.


Secondary Outcome Measures :
  1. Clinical outcome measurement with mRS (Efficacy) [ Time Frame: At 6 months after the last treatment session, compared to baseline ]
    Change of mRS score at 6 months after treatment phase is assessed compared to baseline mRS score.

  2. Degree of targeted portion of AVM occlusion [ Time Frame: 6 months ]
    The degree of the predefined targeted portion of the AVM's occlusion will be assessed angiographically.



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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
Patients with a cerebral AVM for whom endovascular treatment is indicated.
Criteria

Inclusion Criteria:

  1. Patient must sign the informed consent form prior to the index-procedure. If patient is unable to provide it him- or herself because of the patient's medical condition, the informed consent of the patient's legally authorized representative shall be requested.
  2. The patient has an untreated or endovascular previously treated cerebral AVM for which endovascular treatment is indicated.
  3. The patient is at least 18 years old.

Exclusion Criteria:

  1. Patient is pregnant.
  2. Patient with renal insufficiency (GFR < 45 ml/min/1.73 m²)

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): NCT02602990


Locations
Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Emboflu
Archer Research

Responsible Party: Emboflu
ClinicalTrials.gov Identifier: NCT02602990     History of Changes
Other Study ID Numbers: SQUID
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

Keywords provided by Emboflu:
Cerebral
Arteriovenous
Malformation
Embolization
Endovascular

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriovenous Malformations
Intracranial Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Central Nervous System Vascular Malformations
Nervous System Malformations
Hemangioma
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases