NCT02087501

HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Endospan Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 and/or 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 and/or aortoiliac aneurysms, having Iliac/femoral 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).

Conditions

• Infrarenal Abdominal Aortic Aneurysms
• Aortoiliac Aneurysms

Interventions

Type	Name	Description
DEVICE	Horizon™ Abdominal Aortic Aneurysm Stent Graft System	All patient eligible to undergo stent implantation will receive the Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System.

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-04-01
• Completion: 2021-05-01
• First posted: 2014-03-14
• Last updated: 2023-12-05
• Results posted: 2023-12-05

Locations

7 sites across 4 countries: Italy, Netherlands, Serbia, Switzerland