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
  Purpose

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 Intervention Phase
Abdominal Aortic Aneurysm
Device: Ovation™ or Ovation Prime™ Abdominal Stent Graft System
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by TriVascular, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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]


Estimated Enrollment: 500
Study Start Date: May 2011
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372709

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

Additional Information:
No publications provided

Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT01372709     History of Changes
Other Study ID Numbers: 771-0008
Study First Received: June 10, 2011
Last Updated: March 17, 2014
Health Authority: International Competent Authority: Germany

Keywords provided by TriVascular, Inc.:
abdominal
aortic
aneurysm

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

ClinicalTrials.gov processed this record on July 28, 2014