Hellenic Registry of Ovation Altoâ„¢ Abdominal Stent Graft System

NCT ID: NCT05172830

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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Conditions

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Abdominal Aortic Aneurysm

Keywords

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EVAR Endovascular aneurysm repair Ovation Alto

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Group/Cohort

Ovation Altoâ„¢ Abdominal Stent Graft System Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria.

Ovation Altoâ„¢ Abdominal Stent Graft System

Intervention Type DEVICE

Single occurrence permanent implantation of AAA device

Interventions

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Ovation Altoâ„¢ Abdominal Stent Graft System

Single occurrence permanent implantation of AAA device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is \> 18 years of age
* Both IFU and non-adherence to IFU
* Subject intends to electively receive the Ovation Altoâ„¢ 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Patras

OTHER

Sponsor Role collaborator

University Hospital of Crete

OTHER

Sponsor Role collaborator

University Hospital, Alexandroupolis

OTHER

Sponsor Role collaborator

Larissa University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Konstantinos Spanos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Larisssa

Larissa, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Konstantinos Spanos, PhD

Role: CONTACT

Phone: 00306948570321

Email: [email protected]

Athanasios Giannoukas, Prof

Role: CONTACT

Phone: 00306944724146

Email: [email protected]

Facility Contacts

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Konstantinos Spanos, PhD

Role: primary

Athanasios Giannoukas, Prof

Role: backup

Other Identifiers

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986152150

Identifier Type: -

Identifier Source: org_study_id