TriVascular Post-Market Registry

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System

• Study Type: Observational
• Enrollment (Actual): 501

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria
    • Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology
• Belgium
  • Aalst, Belgium
    • O.L. Vrouwziekenhuis
  • Bonheiden, Belgium
    • Imelda Ziekenhuis
  • Dendermonde, Belgium
    • Flanders Medical Research Program
  • Gent, Belgium
    • Universiteit Gent
  • Leuven, Belgium
    • UZ Leuven
• France
  • Lyon, France
    • Groupe Hospitalier Edouard Herriot
  • Paris, France
    • Hôpital Paul d'Egine
• Germany
  • Bad Bevensen, Germany
    • Herz- und Gefässzentrum Bad Bevensen
  • Berlin, Germany
    • Franziskus-Krankenhaus Berlin
  • Frankfurt, Germany
    • Cardiovascular Center
  • Hamburg, Germany
    • Universitäres Herz und Gefaßzentrum Hamburg
  • Karlsruhe, Germany
    • Städtisches klinikum Karlsruhe Klinik für Gefäß- und Thoraxchirurgie
  • Mannheim, Germany
    • "CA Gefäßchirurgie Theresienkrankenhaus/St. Hedwig"
  • Western Saxony Land
    • Leipzig, Western Saxony Land, Germany, 04289
      • Park Hospital Leipzig, Strümpellstr. 41
• Greece
  • Athens, Greece
    • Attikon Hospital
• Italy
  • Milan, Italy
    • Ospedale San Raffaele
  • Milan, Italy
    • Policlinico San Donato
  • Palermo, Italy
    • Ospedale Civico Palermo
  • Reggio Calabria, Italy
    • Ospedale Bianchi Melacrino Morelli
  • Roma, Italy
    • Azienda Ospedaliera Sant'Andrea
  • Roma, Italy
    • Ospedale San Giovanni Addolorata
  • Roma, Italy
    • Università La Sapienza/Policlinico Umberto I
  • Rome, Italy
    • Univeristà La Sapienza/Policlinico Umberto I
  • Torino, Italy
    • Ospedale San Giovanni Bosco
  • Varese, Italy
    • A.O. Ospedale di Circolo e Fondazione Macchi
• Sweden
  • Stockholm, Sweden
    • Södersjukhuset
• United Kingdom
  • Frimley, United Kingdom
    • Frimley Park Hospital NHS Foundation Trust
  • London, United Kingdom
    • St. George's Vascular Institute
  • Manchester, United Kingdom
    • Manchester Royal Infirmary

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: Probability Sample

Study Population

The Ovation™ or Ovation Prime™ Abdominal Stent Graft System study is a multicenter, prospective, observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study intends to expand the clinical evidence of the safety and performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in an all comers ("real world") patient population.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ovation™ or Ovation Prime™ Abdominal Stent Graft System; Adult male and female patients will be consecutively screened for the study. Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria.	Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System; Single occurrence permanent implant of AAA device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: TriVascular, Inc.

Publications and helpful links

Helpful Links

• TriVascular Website

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2011
• Primary Completion (Actual): December 12, 2014
• Study Completion (Actual): June 14, 2019

Study Registration Dates

• First Submitted: June 10, 2011
• First Submitted That Met QC Criteria: June 10, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: aneurysm; aortic; abdominal
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 771-0008