Trial Outcomes & Findings for GORE® EXCLUDER® Endoprosthesis French Mandatory Registry (NCT NCT02308839)

Results Overview

Kaplan-Meier estimate of participant survival at 5 years

Recruitment status

COMPLETED

Target enrollment

181 participants

Primary outcome timeframe

5 years

Results posted on

2020-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	GORE® EXCLUDER® AAA Endoprosthesis GORE® EXCLUDER® AAA Endoprosthesis
Overall Study STARTED	181
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	109

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GORE® EXCLUDER® AAA Endoprosthesis n=181 Participants GORE® EXCLUDER® AAA Endoprosthesis
Age, Continuous	75.4 years STANDARD_DEVIATION 9.0 • n=181 Participants
Sex: Female, Male Female	19 Participants n=181 Participants
Sex: Female, Male Male	162 Participants n=181 Participants
Region of Enrollment France	181 participants n=181 Participants

PRIMARY outcome

Timeframe: 5 years

Kaplan-Meier estimate of participant survival at 5 years

Outcome measures

Outcome measures
Measure	GORE® EXCLUDER® AAA Endoprosthesis n=181 Participants GORE® EXCLUDER® AAA Endoprosthesis
Percentage of Participants Survived at 5 Years	76 Percentage of participants alive

SECONDARY outcome

Timeframe: 5 years

Kaplan-Meier estimate of participant freedom from endoleak (Type I, II and III) at 5 years

Outcome measures

Outcome measures
Measure	GORE® EXCLUDER® AAA Endoprosthesis n=181 Participants GORE® EXCLUDER® AAA Endoprosthesis
Percentage of Participants Free From Endoleak at 5 Years	72 Percentage free from endoleak

SECONDARY outcome

Timeframe: 5 years

Kaplan-Meier estimate of participant freedom from migration at 5 years

Outcome measures

Outcome measures
Measure	GORE® EXCLUDER® AAA Endoprosthesis n=178 Participants GORE® EXCLUDER® AAA Endoprosthesis
Percentage of Participants Free From Migration at 5 Years	100 Percentage free from migration

SECONDARY outcome

Timeframe: 5 years

Kaplan-Meier estimate of participant freedom from aneurysm diameter growth at 5 years

Outcome measures

Outcome measures
Measure	GORE® EXCLUDER® AAA Endoprosthesis n=156 Participants GORE® EXCLUDER® AAA Endoprosthesis
Percentage of Participants Free From Aneurysm Diameter Growth at 5 Years	77 Percentage free from aneurysm growth

SECONDARY outcome

Timeframe: 5 years

Kaplan-Meier estimate of participant freedom from aneurysm related mortality at 5 years

Outcome measures

Outcome measures
Measure	GORE® EXCLUDER® AAA Endoprosthesis n=181 Participants GORE® EXCLUDER® AAA Endoprosthesis
Percentage of Participants Free From Aneurysm Related Mortality at 5 Years	99 Percentage free from mortality

SECONDARY outcome

Timeframe: 5 years

Kaplan-Meier estimate of participant freedom from endovascular or surgical re-intervention at 5 years

Outcome measures

Outcome measures
Measure	GORE® EXCLUDER® AAA Endoprosthesis n=181 Participants GORE® EXCLUDER® AAA Endoprosthesis
Percentage of Participants Free From Endovascular or Surgical Re-intervention at 5 Years	75 Percentage free from re-intervention

SECONDARY outcome

Timeframe: Index Procedure

Participant freedom from surgical conversion at procedure

Outcome measures

Outcome measures
Measure	GORE® EXCLUDER® AAA Endoprosthesis n=181 Participants GORE® EXCLUDER® AAA Endoprosthesis
Percentage of Participants Free From Surgical Conversion at Procedure	100 Percentage free from conversion

Adverse Events

GORE® EXCLUDER® AAA Endoprosthesis

Serious events: 69 serious events

Other events: 89 other events

Deaths: 35 deaths

Serious adverse events

Serious adverse events
Measure	GORE® EXCLUDER® AAA Endoprosthesis n=181 participants at risk GORE® EXCLUDER® AAA Endoprosthesis Registry conducted for reimbursement in France, and no MedDRA coding was required.
General disorders Device Related	3.3% 6/181 • Five year follow-up
General disorders Procedure Related	5.5% 10/181 • Five year follow-up
General disorders Aneurysm Related	9.4% 17/181 • Five year follow-up
General disorders Other	25.4% 46/181 • Five year follow-up

Other adverse events

Other adverse events
Measure	GORE® EXCLUDER® AAA Endoprosthesis n=181 participants at risk GORE® EXCLUDER® AAA Endoprosthesis Registry conducted for reimbursement in France, and no MedDRA coding was required.
General disorders Device Related	2.8% 5/181 • Five year follow-up
General disorders Procedure Related	9.4% 17/181 • Five year follow-up
General disorders Aneurysm Related	34.8% 63/181 • Five year follow-up
General disorders Other	9.4% 17/181 • Five year follow-up

Additional Information

Abe Letter

W.L. Gore & Associates

Phone: 928-864-3113

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place