TriVascular Post-Market Registry

June 3, 2021 updated by: TriVascular, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Gefasszentrum 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
        • Sodersjukhuset
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment Success at 12 Months Post-Implantation/surgery.
Time Frame: 12 Months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and Performance Endpoints
Time Frame: 1, 6, &12 Months
  • 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TriVascular, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 771-0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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