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HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm

NCT02087501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-05

Study results available
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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.

Conditions

  • Infrarenal Abdominal Aortic Aneurysms
  • Aortoiliac Aneurysms

Interventions

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.

Sponsors & Collaborators

  • Endospan Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-04-30
Completion
2021-05-31

Countries

  • Italy
  • Netherlands
  • Serbia
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02087501 on ClinicalTrials.gov