Overview

This trial is active, not recruiting.

Condition abdominal aortic aneurysm
Treatment ovation™ or ovation prime™ abdominal stent graft system
Phase phase 4
Sponsor TriVascular, Inc.
Start date May 2011
End date December 2014
Trial size 501 participants
Trial identifier NCT01372709, 771-0008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
ovation™ or ovation prime™ abdominal stent graft system
Single occurrence permanent implant of AAA device.

Primary Outcomes

Measure
Treatment Success at 12 Months Post-Implantation/surgery.
time frame: 12 Months

Secondary Outcomes

Measure
Safety and Performance Endpoints
time frame: 1, 6, &12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by TriVascular, Inc..