Hellenic Registry of Ovation Alto™ Abdominal Stent Graft System

NCT05172830 | Unknown

• 1 other identifier: 986152150
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

EVAR; Endovascular aneurysm repair; Ovation Alto

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number and Classification of Endoleaks

  1 and 12 months

• Stent Graft Migration

  1 and 12 months

• Abdominal aortic aneurysm sac enlargement

  1 and 12 months

• Aortic neck alteration

  1 and 12 months

• Freedom from abdominal aortic aneurysm rupture

  1 and 12 months

Study Arms (1)

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

Interventions

Ovation Alto™ Abdominal Stent Graft System DEVICE

Single occurrence permanent implantation of AAA device

Group/Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Larissa University Hospital: lead
• University of Patras: collaborator
• University Hospital of Crete: collaborator
• University Hospital, Alexandroupolis: collaborator

Study Sites (1)

University Hospital of Larisssa

Larissa, 41110, Greece

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Konstantinos Spanos, PhD

CONTACT

00306948570321; spanos.kon@gmail.com

Athanasios Giannoukas, Prof

CONTACT

00306944724146; agiannoukas@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 29, 2021
• Study Start: January 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)