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TriVascular Post-Market Registry

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ClinicalTrials.gov Identifier: NCT01372709
Recruitment Status : Active, not recruiting
First Posted : June 14, 2011
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
TriVascular, Inc.

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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System

Study Type : Observational
Actual Enrollment : 501 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Study Start Date : May 2011
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372709


Locations
Germany
Park Hospital Leipzig
Strümpellstr. 41, Leipzig, Germany, 04289
Sponsors and Collaborators
TriVascular, Inc.

Additional Information:
Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT01372709     History of Changes
Other Study ID Numbers: 771-0008
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: October 2016

Keywords provided by TriVascular, Inc.:
abdominal
aortic
aneurysm

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases