TriVascular Post-Market Registry
This study is currently recruiting participants.
Verified November 2012 by TriVascular, Inc.
Sponsor:
TriVascular, Inc.
Information provided by (Responsible Party):
TriVascular, Inc.
ClinicalTrials.gov Identifier:
NCT01372709
First received: June 10, 2011
Last updated: November 9, 2012
Last verified: November 2012
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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: | December 2017 |
| Estimated Primary Completion Date: | December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372709
Contacts
| Contact: Maria Nyakern | +34 697 77 13 47 | mnyakern@trivascular.com |
Locations
| Germany | |
| Park Hospital Leipzig | Recruiting |
| Strümpellstr. 41, Leipzig, Germany, 04289 | |
| Contact: Dierk Scheinert, MD FRCS +49 341 865 1478 dierk.scheinert@gmx.de | |
| Principal Investigator: Dierk Scheinert, MD FRCS | |
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: | November 9, 2012 |
| 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 May 23, 2013