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出境医 / 临床实验 / Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study (APEX-FIH)
Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study (APEX-FIH)
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ruptured or Unruptured Cerebral Aneurysms | Device: TrelliX Embolic Coil System | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study |
| Actual Study Start Date : | November 21, 2018 |
| Estimated Primary Completion Date : | March 31, 2022 |
| Estimated Study Completion Date : | July 31, 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Experimental: TrelliX Embolic Coil System |
Device: TrelliX Embolic Coil System
Embolic coil with shape memory polymer
|
Outcome Measures
Primary Outcome Measures :
- Safety - Serious adverse events [ Time Frame: 30 days ]Rate of freedom from incidence of serious adverse events related to the study
- Efficacy - Angiographic occlusion [ Time Frame: Immediate ]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 [ Time Frame: 6 months and 12 months ]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)]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Locations
| Chile | |
| Hospital Clínico Regional Guillermo Grant Benavente | Recruiting |
| Concepción, Chile | |
| Contact: Jessica Parra +56 41 2723077 jparra@ssconcepcion.cl | |
| Principal Investigator: Pablo Giacaman, MD | |
| Sub-Investigator: Martin Einersen, MD | |
| Instituto de Neurocirugía | Recruiting |
| Santiago, Chile | |
| Contact: Loreto Bravo + 56 2 2575 4843 loreto.bravo@redsalud.gov.cl | |
| Principal Investigator: Daniel Echeverría, MD | |
| Sub-Investigator: Rodrigo Rivera, MD | |
| Sub-Investigator: Juan Sordo, MD | |
Sponsors and Collaborators
Shape Memory Medical, Inc.
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 13, 2019 | ||||||||
| First Posted Date ICMJE | June 17, 2019 | ||||||||
| Last Update Posted Date | April 26, 2021 | ||||||||
| Actual Study Start Date ICMJE | November 21, 2018 | ||||||||
| Estimated Primary Completion Date | March 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study | ||||||||
| Official Title ICMJE | Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study | ||||||||
| 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 | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Ruptured or Unruptured Cerebral Aneurysms | ||||||||
| Intervention ICMJE | Device: TrelliX Embolic Coil System
Embolic coil with shape memory polymer
|
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| Study Arms ICMJE | Experimental: TrelliX Embolic Coil System
Intervention: Device: TrelliX Embolic Coil System
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
30 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 31, 2023 | ||||||||
| Estimated Primary Completion Date | March 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE | |||||||||
| Listed Location Countries ICMJE | Chile | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03988062 | ||||||||
| Other Study ID Numbers ICMJE | CRD1003 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Shape Memory Medical, Inc. | ||||||||
| Study Sponsor ICMJE | Shape Memory Medical, Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Shape Memory Medical, Inc. | ||||||||
| Verification Date | April 2021 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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