Abdominal Aortic Aneurysms With Challenging Anatomy Clinical Trial
— EAGLEOfficial title:
EVAR Treatment With the Endurant Stent Graft of Challenging Anatomy in Experienced Hands, the Real World Experience
| NCT number | NCT01810250 |
| Other study ID # | EAGLE Registry |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 2012 |
| Est. completion date | May 2023 |
| Verified date | December 2023 |
| Source | Catharina Ziekenhuis Eindhoven |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database. This study aims at answering two major questions: 1. Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm? 2. Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | May 2023 |
| Est. primary completion date | January 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age = 18 years or minimum age as required by local regulations - Indication for elective EVAR - Challenging AAA anatomy - Intention to electively implant the Endurant or Endurant II Stent Graft System© - Signed informed consent form Exclusion Criteria: - Subjects with intolerance to contrast media - Chimneys or fenestrated device procedures - High probability of non-adherence to physician's follow-up requirements - Current participation in a concurrent trial that may confound study results |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Catharina Ziekenhuis | Eindhoven | Noord-Brabant |
| Lead Sponsor | Collaborator |
|---|---|
| Catharina Ziekenhuis Eindhoven |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical success | Freedom from:
Increase of AAA diameter > 5 mm (1 month measurement as baseline) Type I&III endoleaks Aneurysm rupture Conversion to surgery Stent graft migration (>10mm) resulting in SAE or reintervention Stent graft occlusion |
12 months | |
| Secondary | Helath Related Quality of Life Scores | EQ-5D VAS EQ-5D index | 12 months |