Abdominal Aortic Aneurysm
Conditions
Keywords
Aneurysm, Aorta, Abdominal
Brief summary
This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA).
Detailed description
The use of abdominal aortic endoprostheses makes the treatment of infra-renal abdominal aortic aneurysms possible, with implantation via the femoral artery, thus avoiding a very invasive surgical procedure. The French National Authority for Health requires a 5-year follow-up as part of the renewal for reimbursement for these endoprostheses.
Interventions
DEVICEGORE® EXCLUDER® Endoprosthesis
Endovascular therapy to treat abdominal aortic aneurysms
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patients requiring abdominal aortic stenting for the treatment of an unruptured infra-renal aortic abdominal aneurysm.
Exclusion criteria
* Patients whose clinical follow-up is not possible, i.eg, patient who cannot return for control visits (e.g. patients living abroad).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Survived at 5 Years | 5 years | Kaplan-Meier estimate of participant survival at 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Free From Migration at 5 Years | 5 years | Kaplan-Meier estimate of participant freedom from migration at 5 years |
| Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years | 5 years | Kaplan-Meier estimate of participant freedom from aneurysm diameter growth at 5 years |
| Percentage of Participants Free From Endoleak at 5 Years | 5 years | Kaplan-Meier estimate of participant freedom from endoleak (Type I, II and III) at 5 years |
| Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years | 5 years | Kaplan-Meier estimate of participant freedom from endovascular or surgical re-intervention at 5 years |
| Percentage of Participants Free From Surgical Conversion at Procedure | Index Procedure | Participant freedom from surgical conversion at procedure |
| Percentage of Participants Free From Aneurysm Related Mortality at 5 Years | 5 years | Kaplan-Meier estimate of participant freedom from aneurysm related mortality at 5 years |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GORE® EXCLUDER® AAA Endoprosthesis GORE® EXCLUDER® AAA Endoprosthesis | 181 |
| Total | 181 |
Baseline characteristics
| Characteristic | GORE® EXCLUDER® AAA Endoprosthesis | — |
|---|---|---|
| Age, Continuous | 75.4 years STANDARD_DEVIATION 9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 181 participants | — |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 162 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 35 / 181 |
| other Total, other adverse events | 89 / 181 |
| serious Total, serious adverse events | 69 / 181 |
Outcome results
Primary
Percentage of Participants Survived at 5 Years
Kaplan-Meier estimate of participant survival at 5 years
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® EXCLUDER® AAA Endoprosthesis | Percentage of Participants Survived at 5 Years | 76 Percentage of participants alive |
Secondary
Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years
Kaplan-Meier estimate of participant freedom from aneurysm diameter growth at 5 years
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® EXCLUDER® AAA Endoprosthesis | Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years | 77 Percentage free from aneurysm growth |
Secondary
Percentage of Participants Free From Aneurysm Related Mortality at 5 Years
Kaplan-Meier estimate of participant freedom from aneurysm related mortality at 5 years
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® EXCLUDER® AAA Endoprosthesis | Percentage of Participants Free From Aneurysm Related Mortality at 5 Years | 99 Percentage free from mortality |
Secondary
Percentage of Participants Free From Endoleak at 5 Years
Kaplan-Meier estimate of participant freedom from endoleak (Type I, II and III) at 5 years
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® EXCLUDER® AAA Endoprosthesis | Percentage of Participants Free From Endoleak at 5 Years | 72 Percentage free from endoleak |
Secondary
Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years
Kaplan-Meier estimate of participant freedom from endovascular or surgical re-intervention at 5 years
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® EXCLUDER® AAA Endoprosthesis | Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years | 75 Percentage free from re-intervention |
Secondary
Percentage of Participants Free From Migration at 5 Years
Kaplan-Meier estimate of participant freedom from migration at 5 years
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® EXCLUDER® AAA Endoprosthesis | Percentage of Participants Free From Migration at 5 Years | 100 Percentage free from migration |
Secondary
Percentage of Participants Free From Surgical Conversion at Procedure
Participant freedom from surgical conversion at procedure
Time frame: Index Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE® EXCLUDER® AAA Endoprosthesis | Percentage of Participants Free From Surgical Conversion at Procedure | 100 Percentage free from conversion |