TriVascular Post-Market Registry

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TriVascular, Inc.
ClinicalTrials.gov Identifier:
NCT01372709
First received: June 10, 2011
Last updated: March 17, 2014
Last verified: March 2014

June 10, 2011
March 17, 2014
May 2011
January 2015   (final data collection date for primary outcome measure)
Treatment Success at 12 Months Post-Implantation/surgery. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
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.
Treatment Success at 12 Months Post-Implantation/surgery. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
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™ 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.
Complete list of historical versions of study NCT01372709 on ClinicalTrials.gov Archive Site
Safety and Performance Endpoints [ Time Frame: 1, 6, &12 Months ] [ Designated as safety issue: Yes ]
  • 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]
Safety and Performance Endpoints [ Time Frame: 1, 6, &12 Months ] [ Designated as safety issue: Yes ]
  • Freedom from type I and III endoleaks [1 and 6 months]
  • Freedom from aneurysm related mortality [1 month]
  • Freedom from stent graft migration [12 months]
  • Freedom from loss of device patency [12 months]
  • Freedom from aneurysm-related secondary endovascular procedures [12 months]
  • Freedom from device related adverse events [12 months]
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

Abdominal Aortic Aneurysm
Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Single occurrence permanent implant of AAA device.
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.
Intervention: Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
January 2019
January 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01372709
771-0008
Yes
TriVascular, Inc.
TriVascular, Inc.
Not Provided
Not Provided
TriVascular, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP