Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

Cerebral Arteriovenous Malformations Clinical Trial

Official title:

Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602990
• Other study ID #: SQUID
• Status: Completed
• Start date: August 2015
• Est. completion date: May 2019

Study information

• Verified date: September 2019
• Source: Emboflu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Cerebral Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations

Intervention

Device:
• SQUID™

Locations

Country	Name	City	State
Belgium	UZ Antwerpen	Edegem
Belgium	Ziekenhuis Oost Limburg (ZOL)	Genk
Belgium	AZ Sint-Lucas	Gent
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven	Leuven
Germany	Alfried Krupp Krankenhaus	Essen

Sponsors (2)

Lead Sponsor	Collaborator
Emboflu	Archer Research

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical outcome measurement with mRS (Efficacy)	Change of mRS score at 6 months after treatment phase is assessed compared to baseline mRS score.	At 6 months after the last treatment session, compared to baseline
Secondary	Degree of targeted portion of AVM occlusion	The degree of the predefined targeted portion of the AVM's occlusion will be assessed angiographically.	6 months