Ignite Creation Date:
2024-05-06 @ 2:37 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02087501
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2014-03-10
Brief Title:
HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm
Sponsor:
Endospan Ltd
Organization:
Endospan Ltd
Study Overview
Official Title:
A Prospective Open-label Non-randomized Pivotal Study to Evaluate the Safety and Performance of the Horizon Abdominal Aortic Aneurysm AAA Stent Graft System
Status:
COMPLETED
Status Verified Date:
2022-02
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:
None
Brief Summary:
Clinical Investigation Design A prospective open-label non-randomized interventional clinical study sponsored by Endospan Ltd Patients will be followed-up for five years
Investigational Device The Horizon Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System
Purpose The purpose of the study is to evaluate the safety and performance of the Horizon AAA Stent Graft System for the treatment of infrarenal abdominal aortic andor aortoiliac aneurysms The results of this study will be used as supportive data for CE Marking submission in the European Union EU
Objectives The primary objectives of the study are to evaluate the safety and performance of the Horizon AAA Stent graft System
Primary End Points Safety endpoints include proportion of patients free from device related Major Adverse Events MAEs within 1 month of the endovascular procedure Performance endpoints include successful delivery and deployment of the device and absence of the following at 1 month follow-up aneurysm growth 5mm type I or III endoleaks stent graft occlusion conversion to open surgery rupture and stent graft migration
Subject population Thirty 30 patients having infrarenal abdominal aortic andor aortoiliac aneurysms having Iliacfemoral access vessel morphology that is compatible with vascular access techniques and devices
Treatment All patients will be treated by implantation of the Horizon Abdominal Aortic Aneurysm Stent graft System
Investigational Device The Horizon Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System
Purpose The purpose of the study is to evaluate the safety and performance of the Horizon AAA Stent Graft System for the treatment of infrarenal abdominal aortic andor aortoiliac aneurysms The results of this study will be used as supportive data for CE Marking submission in the European Union EU
Objectives The primary objectives of the study are to evaluate the safety and performance of the Horizon AAA Stent graft System
Primary End Points Safety endpoints include proportion of patients free from device related Major Adverse Events MAEs within 1 month of the endovascular procedure Performance endpoints include successful delivery and deployment of the device and absence of the following at 1 month follow-up aneurysm growth 5mm type I or III endoleaks stent graft occlusion conversion to open surgery rupture and stent graft migration
Subject population Thirty 30 patients having infrarenal abdominal aortic andor aortoiliac aneurysms having Iliacfemoral access vessel morphology that is compatible with vascular access techniques and devices
Treatment All patients will be treated by implantation of the Horizon Abdominal Aortic Aneurysm Stent graft System
Detailed Description:
Possible benefits
It is believed that the Horizon AAA Stent Graft System implantation may offer a number of benefits over conventional and recently developed treatment options for patients suffering from AAA These other treatment modalities include open surgery and the more recently evolved EVAR
The Horizon AAA Stent graft System has a low profile of 14Fr and is implanted through a percutaneous approach The modular bottom-up construction requires a single-sided femoral access and there is no need for cannulation of the contralateral limb a requirement present in the majority of commercially available devices These features are anticipated to result in a simplified procedure with less surgical trauma shorter procedure time lower levels of radiation exposure and shorter hospitalization periods Moreover the device is flexible enough to reach also tortuous anatomies and its fixation elements reduce the concern of migration and type I endoleaks
As such it is believed that the Horizon AAA Stent graft System may have potential clinical advantages and may exhibit benefits over commercially available stent-grafts
Hypothesis
In this clinical study safety and performance primary endpoints are compared between HORIZON and those reported for the Lifeline Registry of Endovascular Aneurysm Repair Control
It is believed that the Horizon AAA Stent Graft System implantation may offer a number of benefits over conventional and recently developed treatment options for patients suffering from AAA These other treatment modalities include open surgery and the more recently evolved EVAR
The Horizon AAA Stent graft System has a low profile of 14Fr and is implanted through a percutaneous approach The modular bottom-up construction requires a single-sided femoral access and there is no need for cannulation of the contralateral limb a requirement present in the majority of commercially available devices These features are anticipated to result in a simplified procedure with less surgical trauma shorter procedure time lower levels of radiation exposure and shorter hospitalization periods Moreover the device is flexible enough to reach also tortuous anatomies and its fixation elements reduce the concern of migration and type I endoleaks
As such it is believed that the Horizon AAA Stent graft System may have potential clinical advantages and may exhibit benefits over commercially available stent-grafts
Hypothesis
In this clinical study safety and performance primary endpoints are compared between HORIZON and those reported for the Lifeline Registry of Endovascular Aneurysm Repair Control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None