HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm
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.
|Infrarenal Abdominal Aortic Aneurysms Aortoiliac Aneurysms||Device: Horizon™ Abdominal Aortic Aneurysm Stent Graft System|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Safety endpoint: Major adverse events [ Time Frame: 1 month post implantation ]Safety endpoint includes proportion of patients free from MAEs within 1 month post implantation, as adjudicated by an independent clinical events committee (CEC).
- Performance endpoint [ Time Frame: 1 month post implant ]
Performance endpoints will assess the rate of successful aneurysm treatment at 1 month, defined as:
- Successful delivery and deployment of the device.
- Absence of the following, as determined by an independent core-lab: aneurysm growth ≥5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and clinically significant stent graft migration.
- MAEs [ Time Frame: 1 month - 5 years post implantation ]Proportion of patients free from MAEs at 1 month through 5 years post implantation.
- Mortality [ Time Frame: 1 - 12 months ]All-cause mortality and aneurysm-related mortality through 1 and 12 months, Kaplan-Meier survival analysis.
- secondary performance endpoint [ Time Frame: 0 - 12 months post implantation ]Absence of all of the following at 1 year: aneurysm growth ≥5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and stent graft migration.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||April 2020|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
HORIZON AAA Stent Graft
All patients will received the HORIZON AAA Stent Graft
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.
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02087501
|Barzili Medical Center - Vascular Surgery|
|Ashkelon, Israel, 78278|
|Assaf Harofe Medical Center|
|Tzrifin, Israel, 70300|
|Nuovo Ospedale Civile S. Agostino Estense - Chirurgia vascolare|
|Modena, Italy, 41126|
|Azienda Ospedaliera Arcispedale S. Maria Nuova|
|Reggio Emilia, Italy, 42123|
|Azienda Ospedaliera Ordine Mauriziano di Torino|
|Torino, Italy, 10128|
|Catharina Ziekenhuis Eindhoven - department of vascula surgery|
|Eindhoven, Netherlands, 5623|
|Clinical Center of Serbia, Clinic for Vascular Surgery|
|Belgrade, Serbia, 11000|
|Institute for Cardiovascular Diseases Dedinje|
|Belgrade, Serbia, 11040|
|Zurich University Hospital- Klinik für Herz- und Gefässchirurgie|
|Zurich, Switzerland, 8091|