HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm

NCT02087501 | Completed Results

• 1 other identifier: CIP003.00
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 7

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 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

Keywords

Abdominal Aortic Aneurysm; AAA; Abdominal Aortoiliac Aneurysm; Endovascular Aortic Repair; EVAR

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint: Major Adverse Events (MAEs)

  Safety endpoint includes proportion of patients free from MAEs within 1 month post implantation, as adjudicated by an independent clinical events committee (CEC).

  1 month post implantation

• Performance Endpoint

  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.

  1 month post implant

Secondary Outcomes (3)

• MAEs

  1 month - 5 years post implantation

• Mortality

  12 months

• Secondary Performance Endpoint

  12 months post implantation

Study Arms (1)

HORIZON AAA Stent Graft

OTHER

All patients will received the HORIZON AAA Stent Graft

Device: Horizon™ Abdominal Aortic Aneurysm Stent Graft System

Interventions

Horizon™ Abdominal Aortic Aneurysm Stent Graft System DEVICE

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

HORIZON AAA Stent Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female age ≥ 18.
• Presence of at least one of the following:
• i. Abdominal aortic aneurysm ≥ 5.0cm in diameter (perpendicular to the line of flow).
• ii. Abdominal aortic aneurysm 4.5-5.5cm in diameter which increased in size - ≥ 0.5cm over 6 months or 1.0cm over one year.
• iii. Abdominal aortic aneurysm \>50% larger than the normal aortic diameter.
• Patient is considered an appropriate candidate for an elective surgery, as evaluated by Physical Status Classification System I, II or III (American Society of Anesthesiologists).
• Femoral artery diameter of ≥6mm, documented by CTA or MRA that allows endovascular access to the aneurismal site with a 14 Fr delivery catheter.
• Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA or MRA.
• To be eligible to receive the Horizon having the following characteristics, as demonstrated on CTA or MRA imaging:
• I. Infrarenal aortic diameter of 18-28 mm II. Aortic length (lower renal artery to lowest point of aortic bifurcation) of 115-150 mm III. Iliac artery diameter of 10-19 mm IV. Proximal aortic neck length ≥ 15 mm V. Proximal aortic neck angulation ≤ 60° VI. Diameter measured 20mm above aortic bifurcation floor should be ≥ 20mm VII. Aortic bifurcation angulation of ≥ 70°. 7. Patient understands and is voluntarily willing to participate as evidenced by personally signing the Informed Consent document.

You may not qualify if:

• If female and of childbearing potential , patients who are:
• pregnant (as determined by a positive pregnancy test performed between 10 to 5 days before implantation date), or
• intend to become pregnant during the study period, or
• do not accept to use adequate double barrier contraception methods for the entire study duration to avoid pregnancy
• Life expectancy of less than 1 year.
• Any medical condition that, according to the investigator's decision, might expose the patient to increased risk by the investigational device or procedure.
• Patient is in need for an emergent surgery for a ruptured aneurysm.
• Patient with an increased risk for aneurysm rupture, such as, saccular aneurysm, aneurysm with isolated wall protrusion and penetrating ulcers of the aorta.
• A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma.
• Presence of thrombus or atheroma in proximal aortic neck covering \>50% of the endoluminal surface.
• Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to \<6mm.
• Congenital vascular disease in which the placement of the stent graft will cause occlusion of major arterial flow.
• Aneurysm with any of the following characteristics: suprarenal, isolated ilio-femoral, mycotic, inflammatory or para-anastomotic pseudoaneurysm.
• Patient has an untreated thoracic aneurysm \> 5.5 cm in diameter.
• Patient has an aneurysm that involves the part of the aorta at the ostia of the renal arteries.

Sponsors & Collaborators

• Endospan Ltd.: lead

Study Sites (7)

Nuovo Ospedale Civile S. Agostino Estense - Chirurgia vascolare

Modena, 41126, Italy

Location

Azienda Ospedaliera Arcispedale S. Maria Nuova

Reggio Emilia, 42123, Italy

Location

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, 10128, Italy

Location

Catharina Ziekenhuis Eindhoven - department of vascula surgery

Eindhoven, 5623, Netherlands

Location

Clinical Center of Serbia, Clinic for Vascular Surgery

Belgrade, 11000, Serbia

Location

Institute for Cardiovascular Diseases Dedinje

Belgrade, 11040, Serbia

Location

Zurich University Hospital- Klinik für Herz- und Gefässchirurgie

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Hofmann M, Pecoraro F, Planer D, Pfammatter T, Puippe G, Bettex D, Veith FJ, Lachat M, Chaykovska L; FIM and PIVOTAL trialists. Early outcomes with a single-sided access endovascular stent. J Vasc Surg. 2018 Jul;68(1):83-90.e2. doi: 10.1016/j.jvs.2017.11.069. Epub 2018 Mar 27.

  PMID: 29602473 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Jessica Kleine
• Organization: Endospan

j.Kleine@endospan.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 14, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2021
• Last Updated: December 5, 2023
• Results First Posted: December 5, 2023

Record last verified: 2022-02

Locations

NL (1); CH (1); SE (2); IT (3)