Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study

Ruptured or Unruptured Cerebral Aneurysms Clinical Trial

— APEX-FIH  

Official title:

Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03988062
• Other study ID #: CRD1003
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 21, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: Shape Memory Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

APEX-FIH is a first-in-human, open-label prospective multicenter study of the TrelliX Embolic Coil System for use in embolization of the medium to large, ruptured or unruptured cerebral aneurysms

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: December 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subject age =18 and =80 years with a diagnosis of a ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure

• Aneurysm size [largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen) =5 mm and =16mm

• If ruptured aneurysm: either WFNS grade 1 or 2, or Hunt and Hess 1 or 2

• If unruptured aneurysm: Subject grade Modified Rankin Scale mRS 0 - 2

• Investigator plans to use =70% in volume TrelliX coils to fill target aneurysm

Exclusion Criteria:

• Prior treatment (surgical or endovascular) of the target aneurysm

• Planned treatment of multiple aneurysms in index procedure

• Planned use of other modified coils (Matrix, HydroCoil or fibered coils)

• Planned use of liquid embolic material

• Life expectancy less than 12 months

• Presence of arteriovenous malformation

• Fusiform, mycotic, traumatic, or tumoral aneurysms

• Intended or planned aneurysm treatment by parent vessel occlusion

• Clipping or endovascular treatment of another intracranial aneurysm performed within 30 days before or planned within 30 days following the index procedure

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Ruptured or Unruptured Cerebral Aneurysms

Intervention

Device:
• TrelliX Embolic Coil System
Embolic coil with shape memory polymer

Locations

Country	Name	City	State
Chile	Hospital Clínico Regional Guillermo Grant Benavente	Concepción
Chile	Instituto de Neurocirugía	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Shape Memory Medical, Inc.

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Serious adverse events	Rate of freedom from incidence of serious adverse events related to the study	30 days
Primary	Efficacy - Angiographic occlusion	Rate of angiographic occlusion based on Raymond-Ray grading scale [1 No filling of aneurysm neck or dome; 2 Residual filling of aneurysm neck, not dome; 3 Residual filling of aneurysm neck and dome (worst outcome)]	Immediate
Primary	Efficacy - Angiographic occlusion	Rate of angiographic occlusion based on Raymond-Ray grading scale [1 No filling of aneurysm neck or dome; 2 Residual filling of aneurysm neck, not dome; 3 Residual filling of aneurysm neck and dome (worst outcome)]	6 months and 12 months