Neck Evolution With Ovation in Spain (NEOVAS)

April 10, 2023 updated by: DGM Vascular
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-implant infrarenal aneurysm's neck grow evaluation
Time Frame: 30 days
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
Time Frame: 6 months
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
Time Frame: 1 year
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
Time Frame: 2 years
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
Time Frame: 3 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural technical success
Time Frame: Immediately after the procedure
Immediate procedural technical success
Immediately after the procedure
Aneurysm evaluation
Time Frame: 3 years
No Aneurysm rupture
3 years
Related mortality
Time Frame: 3 years
AAA-related mortality
3 years
Secondary Evaluations
Time Frame: 3 years
Conversion to open surgical
3 years
Polymer leak
Time Frame: 3 years
No polymer leak during and after implant
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DGM Vascular

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Universitario Central de Asturias

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manuel Alonso Pérez, MD, Hospital Universitario Central de Asturias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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