Trial Outcomes & Findings for Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms, and Dialysis Access (NCT NCT05124184)

Last Updated: 2025-05-09

Results Overview

Clinical evidence of an infectious process in the direct vicinity of the access site or distal to the treated vascular site or seroma classified by the registry investigator as primarily related to the registry device.

Recruitment status

COMPLETED

Target enrollment

356 participants

Primary outcome timeframe

Data were collected retrospectively from health registries, for up to 5 years after index procedure date

Results posted on

2025-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	PAD Cohort Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts	AAA Cohort Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts	Dialysis Access Cohort Patient required the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease using a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Overall Study STARTED	145	65	146
Overall Study COMPLETED	45	52	72
Overall Study NOT COMPLETED	100	13	74

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	PAD Cohort n=145 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts	AAA Cohort n=65 Participants Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts	Dialysis Access Cohort n=146 Participants Patient required the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease using a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts	Total n=356 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=145 Participants	0 Participants n=65 Participants	0 Participants n=146 Participants	0 Participants n=356 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=145 Participants	25 Participants n=65 Participants	55 Participants n=146 Participants	112 Participants n=356 Participants
Age, Categorical >=65 years	113 Participants n=145 Participants	40 Participants n=65 Participants	91 Participants n=146 Participants	244 Participants n=356 Participants
Age, Continuous	72.2 years STANDARD_DEVIATION 10.7 • n=145 Participants	65.9 years STANDARD_DEVIATION 7.06 • n=65 Participants	66.5 years STANDARD_DEVIATION 13.1 • n=146 Participants	68.7 years STANDARD_DEVIATION 11.58 • n=356 Participants
Sex: Female, Male Female	39 Participants n=145 Participants	8 Participants n=65 Participants	68 Participants n=146 Participants	115 Participants n=356 Participants
Sex: Female, Male Male	106 Participants n=145 Participants	57 Participants n=65 Participants	78 Participants n=146 Participants	241 Participants n=356 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Italy	46 participants n=145 Participants	0 participants n=65 Participants	54 participants n=146 Participants	100 participants n=356 Participants
Region of Enrollment France	96 participants n=145 Participants	65 participants n=65 Participants	36 participants n=146 Participants	197 participants n=356 Participants
Region of Enrollment Spain	3 participants n=145 Participants	0 participants n=65 Participants	56 participants n=146 Participants	59 participants n=356 Participants

PRIMARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 5 years after index procedure date

Outcome measures

Outcome measures
Measure	PAD Cohort n=145 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
PAD Cohort: Primary Safety Outcome: Device-related Seroma or Infection	0 percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 5 years after index procedure date

Patency of the study graft with additional or secondary surgical or endovascular procedures to restore flow to the graft after occlusion or stenosis of the graft or its anastomoses. The only exceptions that do not disqualify the graft for secondary patency are procedures performed for disease beyond the graft and its two anastomoses.

Outcome measures

Outcome measures
Measure	PAD Cohort n=145 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
PAD Cohort: Primary Performance Outcome: Secondary Patency (Revascularization)	75.4 percentage of participants Interval 66.3 to 82.4

PRIMARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 5 years after index procedure date

All Cause survival

Outcome measures

Outcome measures
Measure	PAD Cohort n=65 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Aortic Aneurysm Cohort: Primary Safety Outcome: Survival Through 5 Years	81.3 percentage of participants Interval 69.4 to 88.9

PRIMARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 5 years after index procedure date

Patency of the study graft without additional or secondary surgical or endovascular procedures to maintain or restore flow to the graft. The only exceptions that do not disqualify the graft for primary patency are procedures performed for disease beyond the graft and its two anastomoses.

Outcome measures

Outcome measures
Measure	PAD Cohort n=65 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Aortic Aneurysm Cohort: Primary Performance Outcome: Primary Patency Through 5 Years	96.7 percentage of participants Interval 87.3 to 99.2

PRIMARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 2 years after index procedure date

Clinical evidence of an infectious process in the direct vicinity of the access site classified by the study investigator as primarily related to the study device.

Outcome measures

Outcome measures
Measure	PAD Cohort n=146 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Dialysis Access Cohort: Primary Safety Outcome: Device-related Infection Through 2 Years	0 percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 2 years after index procedure date

Patency of the study graft from the time of access creation or placement until access abandonment.

Outcome measures

Outcome measures
Measure	PAD Cohort n=146 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Dialysis Access Cohort: Useable Access Circuit (Reported as Secondary Patency) Through 2 Years	74.3 percentage of participants Interval 65.7 to 81.0

SECONDARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 1 year after index procedure date

Freedom from an amputation above the level of the ankle of the index limb

Outcome measures

Outcome measures
Measure	PAD Cohort n=145 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Peripheral Artery Disease Cohort: Limb Salvage Through 1 Year	98.3 percentage of participants Interval 93.3 to 99.6

SECONDARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 1 year after index procedure date

Freedom from an amputation above the level of the ankle of the index limb or all cause death

Outcome measures

Outcome measures
Measure	PAD Cohort n=145 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Peripheral Artery Disease Cohort: Amputation-free Survival Through 1 Year	81.6 percentage of participants Interval 73.8 to 87.3

SECONDARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 1 year after index procedure date

Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device

Outcome measures

Outcome measures
Measure	PAD Cohort n=145 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Peripheral Artery Disease Cohort: Device-related Adverse Events Through 1 Year	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 1 year after index procedure date

Outcome measures

Outcome measures
Measure	PAD Cohort n=145 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Peripheral Artery Disease Cohort: Primary Patency Through 1 Year	73.4 percentage of participants Interval 64.9 to 80.1

SECONDARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 5 years after index procedure date

Clinical evidence of an infectious process in the direct vicinity of the access site or distal to the treated vascular site classified by the registry investigator as primarily related to the registry device and required surgical intervention

Outcome measures

Outcome measures
Measure	PAD Cohort n=145 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Peripheral Artery Disease Cohort: Device-related Infection Requiring Reoperation Through 5 Years	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 1 year after index procedure date

Interval following intervention until the next access thrombosis or repeated intervention.

Outcome measures

Outcome measures
Measure	PAD Cohort n=146 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Dialysis Access Cohort: Primary Patency Through 1 Year	60.8 percentage of participants Interval 52.0 to 68.4

SECONDARY outcome

Timeframe: Data were collected retrospectively from health registries, for up to 1 year after index procedure date

Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device

Outcome measures

Outcome measures
Measure	PAD Cohort n=146 Participants Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Dialysis Access Cohort: Device-related Adverse Events Through 1 Year	6.3 percentage of participants Interval 3.2 to 12.2

Adverse Events

PAD Cohort

Serious events: 130 serious events

Other events: 8 other events

Deaths: 54 deaths

AAA Cohort

Serious events: 50 serious events

Other events: 11 other events

Deaths: 12 deaths

Dialysis Access Cohort

Serious events: 101 serious events

Other events: 12 other events

Deaths: 27 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	PAD Cohort n=145 participants at risk Patient was treated for peripheral arterial disease or peripheral arterial aneurysm requiring bypass treated with GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts	AAA Cohort n=65 participants at risk Patient underwent simultaneous or staged aortic aneurysm repair (open surgical AAA or TAAA) involving a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts	Dialysis Access Cohort n=146 participants at risk Patient required the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease using a GORE-TEX® Vascular Graft, GORE® INTERING® Vascular Graft, GORE-TEX® Stretch Vascular Graft or GORE® PROPATEN® Vascular Graft GORE® PROPATEN® Vascular Graft: Patients that have had treatment with GORE® PROPATEN® Vascular Graft GORE-TEX® Vascular Grafts: Patients that have had treatment with GORE-TEX® Vascular Grafts
Injury, poisoning and procedural complications Anastomotic stenosis	0.00% 0/145 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date	0.00% 0/65 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date	8.2% 12/146 • Number of events 15 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date
Injury, poisoning and procedural complications Anemia postoperative	0.00% 0/145 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date	6.2% 4/65 • Number of events 4 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date	0.00% 0/146 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date
Nervous system disorders Carotid artery stenosis	5.5% 8/145 • Number of events 8 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date	0.00% 0/65 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date	0.00% 0/146 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date
Renal and urinary disorders Acute renal insufficiency	0.00% 0/145 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date	13.8% 9/65 • Number of events 9 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date	0.00% 0/146 • Adverse event data were collected retrospectively from health registries, for up to 5 years after index procedure date

Additional Information

Austin Phillips

W. L. Gore & Associates

Phone: +1 928 864 3641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place