Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370182
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-11
Brief Title:
Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device
Sponsor:
Anaconda Biomed SL
Organization:
Anaconda Biomed SL
Study Overview
Official Title:
A Prospective Randomized Dual-arm Multi-center Study to Assess the Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device in Combination With a Stent Retriever
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATHENA
Brief Summary:
The objective of this study is to assess the safety and effectiveness of mechanical thrombectomy using the ANA funnel catheter to treat people with acute ischemic stroke within 24 hours of symptom onset The device facilitates the placement of other devices such as stent retrievers and intravascular catheters during the procedure
Detailed Description:
The objective of this prospective randomized study is to assess the primary safety and effectiveness of mechanical thrombectomy MT using the ANA funnel catheter in its intended use as a device to facilitate the insertion and deployment of other devices ie stent retrievers and intravascular catheters and to allow flow restriction during MT procedures performed in subjects experiencing acute ischemic stroke AIS secondary to large vessel occlusion LVO of the internal carotid artery ICA and treated within 24 hours of symptom onset
Acute reperfusion success after one pass First Pass Effect FPE with ANA will be compared to an active control using the same stent retrievers delivered by an approved guide catheter with or without an intermediate catheter per conventional techniques The study is designed to demonstrate that the use of ANA does not adversely impact the safety and effectiveness of a conventional stent retriever MT procedure
Similar to other ancillary devices used in MT the ANA device is designed to facilitate the delivery of stent retrievers and other catheters during these procedures Its design aims to enhance procedural success and efficiency of stent retriever-based MT procedures by facilitating flow arrest during clot retrieval This approach has been shown to improve rates of revascularization and good clinical outcome after three months Numerous studies have established the value of flow arrest during MT yet it is only used in a minority of procedures most likely due to concerns related to navigability complexity and safety of the currently available devices
Use of the ANA to facilitate MT with a stent retriever may provide a simplified approach to flow restriction and may achieve similar acute reperfusion outcomes to commonly used approaches that combine direct aspiration with an intermediate catheter to actuate clot retrieval with a stent retriever control The study will report acute reperfusion success after a single thrombectomy pass with three of the most commonly employed stent retrievers namely Solitaire Trevo and pRESET Procedural safety will be assessed by comparing the rate of procedure related sICH within 24 hours of the intervention between study arms
Acute reperfusion success after one pass First Pass Effect FPE with ANA will be compared to an active control using the same stent retrievers delivered by an approved guide catheter with or without an intermediate catheter per conventional techniques The study is designed to demonstrate that the use of ANA does not adversely impact the safety and effectiveness of a conventional stent retriever MT procedure
Similar to other ancillary devices used in MT the ANA device is designed to facilitate the delivery of stent retrievers and other catheters during these procedures Its design aims to enhance procedural success and efficiency of stent retriever-based MT procedures by facilitating flow arrest during clot retrieval This approach has been shown to improve rates of revascularization and good clinical outcome after three months Numerous studies have established the value of flow arrest during MT yet it is only used in a minority of procedures most likely due to concerns related to navigability complexity and safety of the currently available devices
Use of the ANA to facilitate MT with a stent retriever may provide a simplified approach to flow restriction and may achieve similar acute reperfusion outcomes to commonly used approaches that combine direct aspiration with an intermediate catheter to actuate clot retrieval with a stent retriever control The study will report acute reperfusion success after a single thrombectomy pass with three of the most commonly employed stent retrievers namely Solitaire Trevo and pRESET Procedural safety will be assessed by comparing the rate of procedure related sICH within 24 hours of the intervention between study arms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None