TriVascular Post-Market Registry

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Abdominal aortic aneurysm
Related Access Program
Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

TriVascular Post-Market Registry

Official Title

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

Brief 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.

Study Type

Observational

Primary Outcome

Treatment Success at 12 Months Post-Implantation/surgery.

Secondary Outcome

 Safety and Performance Endpoints

Condition

Abdominal Aortic Aneurysm

Intervention

Ovation™ or Ovation Prime™ Abdominal Stent Graft System

Study Arms / Comparison Groups

 Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

501

Start Date

May 2011

Completion Date

January 2019

Primary Completion Date

December 2014

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT01372709

Organization ID

771-0008

Responsible Party

Sponsor

Study Sponsor

TriVascular, Inc.

Study Sponsor

, ,

Verification Date

October 2016