Infrarenal Abdominal Aortic AneurysmsNCT02087501
HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm
A study testing Horizon™ Abdominal Aortic Aneurysm Stent Graft System in people with Infrarenal Abdominal Aortic Aneurysms and Aortoiliac Aneurysms, run by Endospan Ltd. at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infrarenal Abdominal Aortic Aneurysms, Aortoiliac Aneurysms
- What is being tested?
- Horizon™ Abdominal Aortic Aneurysm Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Apr 2014to May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female age ≥ 18.
- Presence of at least one of the following:
- Abdominal aortic aneurysm ≥ 5.0cm in diameter (perpendicular to the line of flow).
- Abdominal aortic aneurysm 4.5-5.5cm in diameter which increased in size - ≥ 0.5cm over 6 months or 1.0cm over one year.
- 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).
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- 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:
- 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.
Who cannot join
- 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.
Show all 32Show fewer
- 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.
- Patient has a reversed conical neck defined as a > 4mm distal increase over a 10 mm length.
- Patient has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow.
- Patient whose arterial access site is not anticipated to accommodate the 14 Fr diameter of the Horizon™ Delivery System, due to size, tortuosity or hostile groins (scarring, obesity, or previous failed puncture).
- Patient underwent major surgery or interventional procedure in the last three months.
- Patient is suffering from unstable angina.
- Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation.
- Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
- Contraindication to undergoing angiography.
- Patients with known hypersensitivity or allergy to device materials - Nitinol and Polyester.
- Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta.
- Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes).
- Patient has a history of bleeding diathesis or coagulopathy.
- Active systemic infection at the time of the index procedure documented by either one of the following: pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11,000 mm3).
- Acute renal failure documented by either one of the following: Creatinine > 2.00 mg/dl or > 182 pmol/L; patient on dialysis.
- Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment.
- Active participation in another research study involving an investigational device or new drug.
- -
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Italy3 sites
Nuovo Ospedale Civile S. Agostino Estense - Chirurgia vascolare
Modena, 41126
Azienda Ospedaliera Arcispedale S. Maria Nuova
Reggio Emilia, 42123
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, 10128
Serbia2 sites
Clinical Center of Serbia, Clinic for Vascular Surgery
Belgrade, 11000
Institute for Cardiovascular Diseases Dedinje
Belgrade, 11040
Netherlands1 site
Catharina Ziekenhuis Eindhoven - department of vascula surgery
Eindhoven, 5623
Switzerland1 site
Zurich University Hospital- Klinik für Herz- und Gefässchirurgie
Zurich, 8091
About this study
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
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.
Read more
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.
Read the 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).
- Being tested
- Horizon™ Abdominal Aortic Aneurysm Stent Graft System
- Keywords
- Abdominal Aortic Aneurysm, AAA, Abdominal Aortoiliac Aneurysm, Endovascular Aortic Repair, EVAR
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizon™ Abdominal Aortic Aneurysm Stent Graft SystemDevice
All patient eligible to undergo stent implantation will receive the Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System.
| Study group | Role | What they receive |
|---|---|---|
| HORIZON AAA Stent Graft | Other | All patients will received the HORIZON AAA Stent Graft Receives: Device: Horizon™ Abdominal Aortic Aneurysm Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 1 month post implant
Secondary outcomes (3)
MAEs
Proportion of patients free from MAEs at 1 month through 5 years post implantation.
Measured: 1 month - 5 years post implantation
Mortality
All-cause mortality and aneurysm-related mortality at 12 months, Kaplan-Meier survival analysis.
Measured: 12 months
Secondary Performance Endpoint
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.
Measured: 12 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infrarenal Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endospan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087501
- Sponsor's protocol ID
- CIP003.00
- Status last verified
- Feb 2022
- First submitted
- 10 Mar 2014
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29602473
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02087501
- Acronym / sponsor ID
- CIP003.00
- Keywords
- Abdominal Aortic Aneurysm, AAA, Abdominal Aortoiliac Aneurysm, Endovascular Aortic Repair, EVAR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Endospan Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 5 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HORIZON AAA Stent Graft | Other | Device: Horizon™ Abdominal Aortic Aneurysm Stent Graft SystemAll patients will received the HORIZON AAA Stent Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female age ≥ 18.
- Presence of at least one of the following:
- 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.
Key exclusion criteria (32 listed)
- If female and of childbearing potential , patients who are:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Horizon™ Abdominal Aortic Aneurysm Stent Graft SystemAll patient eligible to undergo stent implantation will receive the Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System. | Device | HORIZON AAA Stent Graft |
Primary outcome
Safety Endpoint: Major Adverse Events (MAEs)
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.
3 secondary outcomes
MAEs
Time frame: 1 month - 5 years post implantation
Mortality
Time frame: 12 months
Secondary Performance Endpoint
Time frame: 12 months post implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29602473Hofmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horizon™ Abdominal Aortic Aneurysm Stent Graft System in people with Infrarenal Abdominal Aortic Aneurysms and Aortoiliac Aneurysms, run by Endospan Ltd. at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Serbia, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint: Major Adverse Events (MAEs) (time frame: 1 month post implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02087501, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.