Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

NCT02602990 | Completed

• 1 other identifier: SQUID
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Conditions

Cerebral Arteriovenous Malformations

Keywords

Cerebral; Arteriovenous; Malformation; Embolization; Endovascular

Outcome Measures

Primary Outcomes (1)

• Incidence of complications / adverse events (Safety)

  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.

  From the start of the procedure until 30 days after procedure

Secondary Outcomes (2)

• Clinical outcome measurement with mRS (Efficacy)

  At 6 months after the last treatment session, compared to baseline

• Degree of targeted portion of AVM occlusion

  6 months

Study Arms (1)

Cerebral AVM treated with SQUID™

Device: SQUID™

Interventions

SQUID™ DEVICE

Cerebral AVM treated with SQUID™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• The patient has an untreated or endovascular previously treated cerebral AVM for which endovascular treatment is indicated.
• The patient is at least 18 years old.

You may not qualify if:

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

Sponsors & Collaborators

• Emboflu: lead
• Archer Research: collaborator

Study Sites (6)

UZ Antwerpen

Edegem, 2650, Belgium

Location

Ziekenhuis Oost Limburg (ZOL)

Genk, 3600, Belgium

Location

AZ Sint-Lucas

Ghent, 9000, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Alfried Krupp Krankenhaus

Essen, 45131, Germany

Location

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2015
• First Posted: November 11, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

BE (5); DE (1)