TriVascular Post-Market Registry

Abdominal Aortic Aneurysm Clinical Trial

Official title:

A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372709
• Other study ID #: 771-0008
• Status: Completed
• Start date: May 2011
• Est. completion date: June 14, 2019

Study information

• Verified date: June 2021
• Source: Endologix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: June 14, 2019
• Est. primary completion date: December 12, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is > 18 years or minimum age as required by local regulations.
• Indication for elective repair of AAA with an endovascular stent graft in accordance with the Instructions for Use of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System.
• Subject has signed an Ethics Committee (EC) approved Informed Consent Form. The subject or legal representative has been informed of the nature of the study, has consented to participate, and has authorized the collection and release of his/her medical information.
• Subject intends to electively receive the Ovation™ or Ovation Prime™ 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 demonstrates high probability of non-adherence to physician's follow-up requirements.
• 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™ or Ovation Prime™ Abdominal Stent Graft System
Single occurrence permanent implant of AAA device.

Locations

Country	Name	City	State
Austria	Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology	Wien
Belgium	O.L. Vrouwziekenhuis	Aalst
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	Flanders Medical Research Program	Dendermonde
Belgium	Universiteit Gent	Gent
Belgium	UZ Leuven	Leuven
France	Groupe Hospitalier Edouard Herriot	Lyon
France	Hôpital Paul d'Egine	Paris
Germany	Herz- und Gefässzentrum Bad Bevensen	Bad Bevensen
Germany	Franziskus-Krankenhaus Berlin	Berlin
Germany	Cardiovascular Center	Frankfurt
Germany	Universitäres Herz und Gefaßzentrum Hamburg	Hamburg
Germany	Städtisches klinikum Karlsruhe Klinik für Gefäß- und Thoraxchirurgie	Karlsruhe
Germany	Park Hospital Leipzig, Strümpellstr. 41	Leipzig	Western Saxony Land
Germany	"CA Gefäßchirurgie Theresienkrankenhaus/St. Hedwig"	Mannheim
Greece	Attikon Hospital	Athens
Italy	Ospedale San Raffaele	Milan
Italy	Policlinico San Donato	Milan
Italy	Ospedale Civico Palermo	Palermo
Italy	Ospedale Bianchi Melacrino Morelli	Reggio Calabria
Italy	Azienda Ospedaliera Sant'Andrea	Roma
Italy	Ospedale San Giovanni Addolorata	Roma
Italy	Università La Sapienza/Policlinico Umberto I	Roma
Italy	Univeristà La Sapienza/Policlinico Umberto I	Rome
Italy	Ospedale San Giovanni Bosco	Torino
Italy	A.O. Ospedale di Circolo e Fondazione Macchi	Varese
Sweden	Södersjukhuset	Stockholm
United Kingdom	Frimley Park Hospital NHS Foundation Trust	Frimley
United Kingdom	St. George's Vascular Institute	London
United Kingdom	Manchester Royal Infirmary	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
TriVascular, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Greece,  Italy,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Success at 12 Months Post-Implantation/surgery.	The primary endpoint is treatment success at 12 months post-implantation/surgery. Treatment success is defined as a composite technical endpoint composed of successful introduction and deployment of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System at the initial implantation procedure along with clinical endpoints of absence from type I or III endoleaks, aneurysm expansion, aneurysm rupture, conversion to open surgical repair, graft migration, and graft occlusion at 12 months post-implantation procedure.	12 Months
Secondary	Safety and Performance Endpoints	Freedom from type I and III endoleaks [1 & 6 m, & annual through 5 years]; Freedom from aneurysm rupture [6 m, & annual through 5 years]; Freedom from aneurysm related mortality [1 month]; Freedom from aneurysm expansion [6 m, & annual through 5 years]; Freedom from stent graft migration [6 m, & annual through 5 years]; Freedom from loss of device patency [1 & 6 m, & annual through 5 years]; Freedom from aneurysm-related secondary endovascular procedures [1 & 6 m, & annual through 5 years]; Freedom from device related adverse events [1 & 6 m, & annual through 5 years]	1, 6, &12 Months

External Links

•   TriVascular Website