Back to resultsAneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study (APEX-FIH)
Primary Purpose
Ruptured or Unruptured Cerebral Aneurysms
Status
Active
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
TrelliX Embolic Coil System
Sponsored by
About this trial
This is an interventional treatment trial for Ruptured or Unruptured Cerebral Aneurysms
Eligibility Criteria
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
Sites / Locations
- Hospital Clínico Regional Guillermo Grant Benavente
- Instituto de Neurocirugía
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TrelliX Embolic Coil System
Arm Description
Outcomes
Primary Outcome Measures
Safety - Serious adverse events
Rate of freedom from incidence of serious adverse events related to the study
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)]
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)]
Secondary Outcome Measures
Full Information
NCT ID
NCT03988062
First Posted
June 13, 2019
Last Updated
October 24, 2022
Sponsor
Shape Memory Medical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03988062
Brief Title
Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study
Acronym
APEX-FIH
Official Title
Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shape Memory Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ruptured or Unruptured Cerebral Aneurysms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TrelliX Embolic Coil System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TrelliX Embolic Coil System
Intervention Description
Embolic coil with shape memory polymer
Primary Outcome Measure Information:
Title
Safety - Serious adverse events
Description
Rate of freedom from incidence of serious adverse events related to the study
Time Frame
30 days
Title
Efficacy - Angiographic occlusion
Description
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)]
Time Frame
Immediate
Title
Efficacy - Angiographic occlusion
Description
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)]
Time Frame
6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Clínico Regional Guillermo Grant Benavente
City
Concepción
Country
Chile
Facility Name
Instituto de Neurocirugía
City
Santiago
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
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Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study
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