Clinical trial NCT02087501: HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infrarenal Abdominal Aortic Aneurysms
Aortoiliac Aneurysms
Keywords: Abdominal Aortic Aneurysm
AAA
Abdominal Aortoiliac Aneurysm
Endovascular Aortic Repair
EVAR
Lead sponsor: Endospan Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria:

1. Male and female age ≥ 18.
2. 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.
3. 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).
4. Femoral artery diameter of ≥6mm, documented by CTA or MRA that allows endovascular access to the aneurismal site with a 14 Fr delivery catheter.
5. Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA or MRA.
6. 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.

Exclusion Criteria:

1. If female and of childbearing potential , patients who are:

   1. pregnant (as determined by a positive pregnancy test performed between 10 to 5 days before implantation date), or
   2. intend to become pregnant during the study period, or
   3. do not accept to use adequate double barrier contraception methods for the entire study duration to avoid pregnancy
2. Life expectancy of less than 1 year.
3. Any medical condition that, according to the investigator's decision, might expose the patient to increased risk by the investigational device or procedure.
4. Patient is in need for an emergent surgery for a ruptured aneurysm.
5. Patient with an increased risk for aneurysm rupture, such as, saccular aneurysm, aneurysm with isolated wall protrusion and penetrating ulcers of the aorta.
6. A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma.
7. Presence of thrombus or atheroma in proximal aortic neck covering \>50% of the endoluminal surface.
8. Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to \<6mm.
9. Congenital vascular disease in which the placement of the stent graft will cause occlusion of major arterial flow.
10. Aneurysm with any of the following characteristics: suprarenal, isolated ilio-femoral, mycotic, inflammatory or para-anastomotic pseudoaneurysm.
11. Patient has an untreated thoracic aneurysm \> 5.5 cm in diameter.
12. Patient has an aneurysm that involves the part of the aorta at the ostia of the renal arteries.
13. Patient has a reversed conical neck defined as a \> 4mm distal increase over a 10 mm length.
14. Patient has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow.
15. 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).
16. Patient underwent major surgery or interventional procedure in the last three months.
17. Patient is suffering from unstable angina.
18. Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation.
19. Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
20. Contraindication to undergoing angiography.
21. Patients with known hypersensitivity or allergy to device materials - Nitinol and Polyester.
22. Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta.
23. Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes).
24. Patient has a history of bleeding diathesis or coagulopathy.
25. 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).
26. Acute renal failure documented by either one of the following: Creatinine \> 2.00 mg/dl or \> 182 pmol/L; patient on dialysis.
27. 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.
28. Active participation in another research study involving an investigational device or new drug.

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Primary outcomes:
measure: Safety Endpoint: Major Adverse Events (MAEs)
timeFrame: 1 month post implantation
measure: Performance Endpoint
timeFrame: 1 month post implant
Secondary outcomes:
measure: MAEs
timeFrame: 1 month - 5 years post implantation
measure: Mortality
timeFrame: 12 months
measure: Secondary Performance Endpoint
timeFrame: 12 months post implantation
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Nuovo Ospedale Civile S. Agostino Estense - Chirurgia vascolare
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera Arcispedale S. Maria Nuova
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven - department of vascula surgery
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia, Clinic for Vascular Surgery
city: Belgrade
country: Serbia
facility: Institute for Cardiovascular Diseases Dedinje
city: Zurich
country: Switzerland
facility: Zurich University Hospital- Klinik für Herz- und Gefässchirurgie
Study officials:
References:
citation: 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.