Hellenic Registry of Ovation Alto™ Abdominal Stent Graft System

Hellenic Registry of Subjects Receiving the Ovation Alto™ Abdominal Stent Graft System

This is a Hellenic Registry including both retrospective and prospective subjects receiving the Ovation Alto™ Abdominal Stent Graft System ("Ovation Alto™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation Alto™ Hellenic Registry is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation Alto™ Abdominal Stent Graft System in actual clinical practice during the first post-operative year.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Ovation Alto™ Abdominal Stent Graft System

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Konstantinos Spanos, PhD; Phone Number: 00306948570321; Email: spanos.kon@gmail.com
• Study Contact Backup: Name: Athanasios Giannoukas, Prof; Phone Number: 00306944724146; Email: agiannoukas@hotmail.com

Study Locations

• Greece
  • Larissa, Greece, 41110
    • Recruiting
    • University Hospital of Larisssa
    • Contact: Konstantinos Spanos, PhD; Phone Number: 00306948570321; Email: spanos.kon@gmail.com
    • Contact: Athanasios Giannoukas, Prof; Phone Number: 00306944724146; Email: agiannoukas@gmail.com
    • Sub-Investigator: George Kouvelos, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated electively with Ovation Alto™ Abdominal Stent Graft System for Endovascular Aneurysm Repair

Description

Inclusion Criteria:

• Subject is > 18 years of age
• Both IFU and non-adherence to IFU
• Subject intends to electively receive the Ovation Alto™ Abdominal Stent Graft System
• Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan

Exclusion Criteria:

• Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
• Life expectancy less than 1 year
• Pregnancy
• Subjects with poor renal function as indicated by a serum creatinine > 2.5mg/dl.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group/Cohort; Ovation Alto™ Abdominal Stent Graft System Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria.	Device: Ovation Alto™ Abdominal Stent Graft System; Single occurrence permanent implantation of AAA device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success	Treatment success is defined as technical success, freedom from type I and III endoleaks at 12 months, freedom from stent graft migration > 10m at 12 months compared to 1 month baseline, freedom from AAA enlargement >5mm at 12 months (compared to 1-month baseline, freedom from AAA rupture through 12 months, freedom from conversion to open repair through 12 months, stent graft stenosis, occlusion or kink requiring secondary intervention through 12 months, thromboembolic event attributable to stent graft requiring secondary intervention through 12 months, stent fracture requiring secondary intervention through 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Classification of Endoleaks	Endoleak type Ia and Ib and III	1 and 12 months
Stent Graft Migration	Any proximal caudal Stent Graft Migration >10mm	1 and 12 months
Abdominal aortic aneurysm sac enlargement	Any sac enlargement > 5mm	1 and 12 months
Aortic neck alteration	Any neck diameter increase at supra-renal part of the aorta (at 0mm, 10mm and 20mm above the highest renal artery), and infra-renal part of the aorta (at 0mm, 7mm, and 15mm below the lowest renal artery). Measurements of the aortic neck angulation will also be included	1 and 12 months
Freedom from abdominal aortic aneurysm rupture	Recording of any abdominal aortic aneurysm rupture that takes place during the follow up after the procedure in order to assess freedom from this adverse event	1 and 12 months
Number of Secondary Interventions	Any secondary intervention stent-graft related including: proximal extension with a balloon expandable covered stent; stent graft extension distally to common iliac arteries; use of onyx for Endoleak Ia; bare metal stent in external iliac arteries	1 and 12 months
AAA-related mortality	Any aneurysm related mortality	1 and 12 months
Device-related Adverse Events (AEs)	Device-related Adverse Events: loss of latency, stent fracture, migration, Endoleak type I and III	1 and 12 months
Major adverse events	Including death, myocardial infarction, stroke, chronic renal disease, stent graft infection, amputation	1 and 12 months
Adherence to instruction for use	Recording of patients in terms of adherence to instructions for use according to the device manual	12 months

Collaborators and Investigators

• Sponsor: Larissa University Hospital
• Collaborators: University Hospital of Crete; University of Patras; University Hospital, Alexandroupolis

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: December 11, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 11, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: EVAR; Endovascular aneurysm repair; Ovation Alto
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 986152150

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: No