Neck Evolution With Ovation in Spain

Abdominal Aortic Aneurysm Clinical Trial

— NEOVAS  

Official title:

Neck Evolution With Ovation in Spain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823519
• Other study ID #: NEOVAS
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2023
• Source: DGM Vascular
• Contact: Manuel Alonso Pérez, MD
• Phone: 985 10 80 00
• Email: manuel.alonsop[@]sespa.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitario De Cruces	Baracaldo	Bizkaia
Spain	Hospital De La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitario Germans Trias i Pujol	Barcelona
Spain	Hospital Universitario De Burgos	Burgos	Castilla Y Leon
Spain	Hospital Universitario De Cabueñes	Gijon	Principado De Asturias
Spain	Hospital Universitario De Girona Dr. Josep Trueta	Girona	Barcelona
Spain	Hospital Universitari Son Espases	Palma de Mallorca	Islas Baleares
Spain	Hospital Universitario de Salamanca	Salamanca	Castilla Y León
Spain	Hospital General Universitario De Toledo	Toledo	Castilla La Mancha

Sponsors (2)

Lead Sponsor	Collaborator
DGM Vascular	Hospital Universitario Central de Asturias

Country where clinical trial is conducted

Spain, 

Outcome

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