Neck Evolution With Ovation in Spain (NEOVAS)

This is a multicenter, observational, prospective, single arm registry using Ovation Alto Endograft. A minimum of 50 up to a maximum of 120 subjects undergoing endovascular repair with Ovation Alto endograft will be enrolled and followed procedurally to discharge, at 1month, 6 months, 1 year and yearly afterward up to 3 years. This registry of Ovation Alto endograft will provide further assessment to confirm continuing safety and effectiveness of the graft and to confirm the stability of the neck diameter over time when treated with this device.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Endologix Ovation Alto Endograft

Detailed Description

Abdominal Aortic Aneurysm (AAA) is a widespread disease with a high mortality rate in case of ruptures, with a sizable number of patients dying before a diagnosis is made. Approximately 32.000 patients are newly diagnosed with AAA and about 44.000 repair procedures are performed in the US every year. It is estimated that up to 2.000.000 subjects are living with an undiagnosed AAA with a greater incidence in the elderly population >65 years. Risk factors include smoking, hypertension, hypercholesterolemia, gender (men/women ratio 5:1) and family history (15-20%) increase risk amongst first degree relatives. The rupture risk increases with age and concomitant hypertension as well as current tobacco use and presence of other cardio-vascular diseases. AAA is clinically defined as a focal dilatation of the aorta causing a diameter increase of >50% of the expected normal diameter. Although any artery may develop an aneurysm, they are most commonly observed in the infrarenal abdominal aorta, thoracic aorta, popliteal artery and common iliac artery. The concomitants risks related to aneurysms are rupture and thrombus migration. Aneurysms slowly and continually grow in size leading to the aneurysm bursts. The larger an aneurysm becomes, the likelihood of eventual rupture may appear. The natural outcomes of aortic aneurysms is to enlarge and rupture. Other potential complications of the aneurysm include compression of adjacent organs which may result in aortoenteric fistula, or aortocaval fistula. If the thrombus embolizes and flows down the blood stream, this can induce acute or chronic arterial obliteration of the lower limbs.The risk of rupture is weighed against the risk of perioperative morbidity. The United Kingdom Small Aneurysm trial (UKSAT) reported 103 aneurysm ruptures in 2,257 subjects over a period of seven years, with an annual rupture rate of 2.2%. The decision to treat a patient that presents with an asymptomatic aneurysm is primarily dependent upon the size of the aneurysm. Current Society for Vascular Surgery (SVS) practice guidelines recommend surveillance for most subjects with a fusiform AAA in the range of 4.0 to 5.4cm in maximum diameter; therefore, surgical repair of abdominal aneurysms of 5.5 cm or greater in diameter is recommended in healthy subjects, as it is repair of saccular aneurysms. With the development of endovascular treatment options in recent years, treatment of AAA has become a viable option for patients with a high pre-operative risk. Endovascular Aneurysm Repair (EVAR) has become the treatment strategy of choice for AAA. Nowadays, the most important limit to the effectiveness of this technique is represented by complex anatomical situations, especially regarding the morphology of the proximal sealing zone. In previously published studies, the use of EVAR outside the specific instructions for use (IFU) of the devices for patients with challenging proximal aortic necks yielded a non-negligible rate of immediate complications and re-interventions. The Ovation iX and Alto endografts represent a new technical step in EVAR. This new device separates fixation from sealing: fixation is guaranteed by suprarenal stent and anchors, while sealing is ensured by inflatable rings filled with a low-viscosity, non-embolic, radiopaque fill polymer. This unique characteristic allows this graft to isolate aortic neck from blood pressure without radial force, with the result of very low ratios of Type 1 Endoleaks and absence aortic neck growing. The presence of the polymer-filled network also allows the graft to conform to the patient's aortic neck, providing precise and reliable sealing in a great variety of anatomies. Different from common stent-graft platforms, separation between fixation and sealing ensures that stent and fabric do not compete in the Ovation endograft for the same space within the shaft, and an ultra-low-profile delivery system can be achieved, allowing the treatment of patients presenting a wide range of iliac access.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Manuel Alonso Pérez, MD; Phone Number: 985 10 80 00; Email: manuel.alonsop@sespa.es

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Hospital De La Santa Creu I Sant Pau
    • Contact: Jaume Felix Dilmé Muñoz, MD
    • Principal Investigator: Jaume Felix Dilmé Muñoz, MD
  • Barcelona, Spain, 08916
    • Recruiting
    • Hospital Universitario Germans Trias i Pujol
    • Principal Investigator: Secundino Llagostera Pujol, MD
    • Contact: Secundino Llagostera Pujol, MD
  • Barcelona
    • Girona, Barcelona, Spain, 17007
      • Recruiting
      • Hospital Universitario de Girona Dr. Josep Trueta
      • Contact: Omar Aitor Andrés Navarro, MD
      • Principal Investigator: Omar Aitor Andrés Navarro, MD
  • Bizkaia
    • Baracaldo, Bizkaia, Spain, 48903
      • Recruiting
      • Hospital Universitario de Cruces
      • Contact: Juan Luis Fonseca Legrand, MD
      • Principal Investigator: Juan Luis Fonseca Legrand, MD
  • Castilla La Mancha
    • Toledo, Castilla La Mancha, Spain, 45007
      • Recruiting
      • Hospital General Universitario de Toledo
      • Contact: Antonio Orgaz Pérez-Grueso, MD
      • Principal Investigator: Antonio Orgaz Pérez-Grueso, MD
      • Principal Investigator: Angel Flores Herrero, MD
  • Castilla Y Leon
    • Burgos, Castilla Y Leon, Spain, 09006
      • Recruiting
      • Hospital Universitario de Burgos
      • Contact: Ignacio Agundéz Gómez, MD
      • Principal Investigator: Ignacio Agundéz Gómez, MD
  • Castilla Y León
    • Salamanca, Castilla Y León, Spain, 37007
      • Recruiting
      • Hospital Universitario de Salamanca
      • Contact: Francisco Santiago Lozano Sánchez, MD
      • Principal Investigator: Francisco Santiago Lozano Sánchez, MD
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07120
      • Recruiting
      • Hospital Universitari Son Espases
      • Contact: Pascual Lozano Vilardell, MD
      • Principal Investigator: Pascual Lozano Vilardell, MD
  • Principado De Asturias
    • Gijon, Principado De Asturias, Spain, 33394
      • Recruiting
      • Hospital Universitario de Cabueñes
      • Contact: Luis Javier Álvarez Fernández, MD
      • Principal Investigator: Luis Javier Álvarez Fernández, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male or female at least 18 years old with aortic abdominal aneurysm with characteristics within the IFU of de device

Description

Inclusion Criteria:

1. Male or female at least 18 years old.
2. Subject has signed informed consent for data release.
3. Subjects with de novo infrarenal AAA /aorto-iliac AAA and eligible for endovascular Abdominal Aortic Aneurysm Repair with the Ovation Alto Endograft according to current IFU.

Exclusion Criteria:

1. Currently participating in another study where primary endpoint has not been reached yet.
2. Currently participating in another study with the same devices and/or the same primary endpoint.
3. Known allergy to any of the device components.
4. Pregnant (females of childbearing potential only).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

SINGLE Arm; Observational, Multicenter, Prospective, single arm registry study with consecutive, eligible patient enrollment at each site. Subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 3 years (total follow-up commitment), with follow up including Computed tomography angiography (CTA) study and Case Report Form data at 1 month, 6 months, 1 years, 2 years and 3 years, closing at this time the study primary endpoint.

Device: Endologix Ovation Alto Endograft; Implantation of aorto-bisiliac ALTO endograft to exclude Abdominal Aortic Aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-implant infrarenal aneurysm's neck grow evaluation	The neck diameter will be measured on Computed Tomography Angiography (CTA) at 0mm (lowest renal artery), 5mm, 10mm, 15mm and 20mm. No type I or III endoleak. No clinically significant migration (>5mm). No Aneurysm enlargement (>5mm)	30 days
Post-implant infrarenal aneurysm's neck grow evaluation	The neck diameter will be measured on Computed Tomography Angiography (CTA) at 0mm (lowest renal artery), 5mm, 10mm, 15mm and 20mm. No type I or III endoleak. No clinically significant migration (>5mm). No Aneurysm enlargement (>5mm)	6 months
Post-implant infrarenal aneurysm's neck grow evaluation	The neck diameter will be measured on Computed Tomography Angiography (CTA) at 0mm (lowest renal artery), 5mm, 10mm, 15mm and 20mm. No type I or III endoleak. No clinically significant migration (>5mm). No Aneurysm enlargement (>5mm)	1 year
Post-implant infrarenal aneurysm's neck grow evaluation	The neck diameter will be measured on Computed Tomography Angiography (CTA) at 0mm (lowest renal artery), 5mm, 10mm, 15mm and 20mm. No type I or III endoleak. No clinically significant migration (>5mm). No Aneurysm enlargement (>5mm)	2 years
Post-implant infrarenal aneurysm's neck grow evaluation	The neck diameter will be measured on Computed Tomography Angiography (CTA) at 0mm (lowest renal artery), 5mm, 10mm, 15mm and 20mm. No type I or III endoleak. No clinically significant migration (>5mm). No Aneurysm enlargement (>5mm)	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural technical success	Immediate procedural technical success	Immediately after the procedure
Aneurysm evaluation	No Aneurysm rupture	3 years
Related mortality	AAA-related mortality	3 years
Secondary Evaluations	Conversion to open surgical	3 years
Polymer leak	No polymer leak during and after implant	3 years

Collaborators and Investigators

• Sponsor: DGM Vascular
• Collaborators: Hospital Universitario Central de Asturias
• Investigators: Principal Investigator: Manuel Alonso Pérez, MD, Hospital Universitario Central de Asturias

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Abdominal Aortic Aneurysm; Alto Endograft
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: NEOVAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes