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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).
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® EXCLUDER® Endoprosthesis | Device | Endovascular therapy to treat abdominal aortic aneurysms |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Survived at 5 Years | Kaplan-Meier estimate of participant survival at 5 years | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years |
| Percentage of Participants Free From Migration at 5 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring treatemtn with an endoprosthesis for the treatment of an unruptured infra-renal aortic abdominal aneurysm.
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| Name | Affiliation | Role |
|---|---|---|
| Eric Steinmetz, Prof | Centre Hospitalier Universitaire du Bocage | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Dijon | Dijon | 21034 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | GORE® EXCLUDER® AAA Endoprosthesis | GORE® EXCLUDER® AAA Endoprosthesis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GORE® EXCLUDER® AAA Endoprosthesis | GORE® EXCLUDER® AAA Endoprosthesis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Survived at 5 Years | Kaplan-Meier estimate of participant survival at 5 years | Posted | Number | Percentage of participants alive | 5 years |
|
|
Five year follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GORE® EXCLUDER® AAA Endoprosthesis | GORE® EXCLUDER® AAA Endoprosthesis Registry conducted for reimbursement in France, and no MedDRA coding was required. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Related | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Related | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abe Letter | W.L. Gore & Associates | 928-864-3113 | aletter@wlgore.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 29, 2012 | May 7, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2017 | May 7, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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Kaplan-Meier estimate of participant freedom from migration at 5 years
| 5 years |
| Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years | Kaplan-Meier estimate of participant freedom from aneurysm diameter growth at 5 years | 5 years |
| Percentage of Participants Free From Aneurysm Related Mortality at 5 Years | Kaplan-Meier estimate of participant freedom from aneurysm related mortality at 5 years | 5 years |
| 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 | 5 years |
| Percentage of Participants Free From Surgical Conversion at Procedure | Participant freedom from surgical conversion at procedure | Index Procedure |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | Posted | Number | Percentage free from endoleak | 5 years |
|
|
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| Secondary | Percentage of Participants Free From Migration at 5 Years | Kaplan-Meier estimate of participant freedom from migration at 5 years | Posted | Number | Percentage free from migration | 5 years |
|
|
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| 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 | Posted | Number | Percentage free from aneurysm growth | 5 years |
|
|
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| 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 | Posted | Number | Percentage free from mortality | 5 years |
|
|
|
| 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 | Posted | Number | Percentage free from re-intervention | 5 years |
|
|
|
| Secondary | Percentage of Participants Free From Surgical Conversion at Procedure | Participant freedom from surgical conversion at procedure | Posted | Number | Percentage free from conversion | Index Procedure |
|
|
|
| 35 |
| 181 |
| 69 |
| 181 |
| 89 |
| 181 |
| Procedure Related | General disorders | Non-systematic Assessment | Procedure Related but not Device Related |
|
| Aneurysm Related | General disorders | Non-systematic Assessment | Aneurysm Related but not Device Related or Procedure Related |
|
| Other | General disorders | Non-systematic Assessment |
|
| Procedure Related | General disorders | Non-systematic Assessment | Procedure Related but not Device Related |
|
| Aneurysm Related | General disorders | Non-systematic Assessment | Aneurysm Related but not Device Related or Procedure Related |
|
| Other | General disorders | Non-systematic Assessment |
|
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