Hellenic Registry of Ovation Alto™ Abdominal Stent Graft System

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05172830
• Other study ID #: 986152150
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: Larissa University Hospital
• Contact: Konstantinos Spanos, PhD
• Phone: 00306948570321
• Email: spanos.kon[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Ovation Alto™ Abdominal Stent Graft System
Single occurrence permanent implantation of AAA device

Locations

Country	Name	City	State
Greece	University Hospital of Larisssa	Larissa

Sponsors (4)

Lead Sponsor	Collaborator
Larissa University Hospital	University Hospital of Crete, University Hospital, Alexandroupolis, University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number and Classification of Endoleaks	Endoleak type Ia and Ib and III	1 and 12 months
Secondary	Stent Graft Migration	Any proximal caudal Stent Graft Migration >10mm	1 and 12 months
Secondary	Abdominal aortic aneurysm sac enlargement	Any sac enlargement > 5mm	1 and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	AAA-related mortality	Any aneurysm related mortality	1 and 12 months
Secondary	Device-related Adverse Events (AEs)	Device-related Adverse Events: loss of latency, stent fracture, migration, Endoleak type I and III	1 and 12 months
Secondary	Major adverse events	Including death, myocardial infarction, stroke, chronic renal disease, stent graft infection, amputation	1 and 12 months
Secondary	Adherence to instruction for use	Recording of patients in terms of adherence to instructions for use according to the device manual	12 months