AAA - Abdominal Aortic Aneurysm, End-Stage Renal Disease, PAD - Peripheral Arterial Disease
Conditions
Brief summary
This multicenter, single-arm retrospective registry (chart review) is being conducted to confirm the clinical performance and safety of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft throughout the device functional lifetime for each indication area.
Detailed description
Up to 9 sites in Europe will be required to enroll 353 patients that have had treatment with GORE-TEX® Vascular Grafts or GORE® PROPATEN® Vascular Grafts in the following indication areas: 144 patients in PAD Cohort * 72 Patients with any GORE-TEX® Vascular Graft * 72 Patients with GORE® PROPATEN® 65 patients in Aortic Aneurysm Cohort with GORE-TEX® Vascular Graft 144 patients in Dialysis Access Cohort * 72 patients implanted with any GORE-TEX® Vascular Graft * 72 Patients implanted with Patients with GORE® PROPATEN®
Interventions
DEVICEGORE® PROPATEN® Vascular Graft
Patients that have had treatment with GORE® PROPATEN® Vascular Graft
DEVICEGORE-TEX® Vascular Grafts
Patients that have had treatment with GORE-TEX® Vascular Grafts
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
General Inclusion Criteria 1. Patient is willing and able to provide written informed consent or consent is waived, according to national and local regulations. 2. Patient was at least 18 years of age at the time of implant. PAD Cohort Inclusion Criteria 1. 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 at least 5 years before site initiation. Aortic Aneurysm Cohort Inclusion Criteria 1\. 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 at least 5 years before site initiation. Research device could have been used to replace or bypass either a diseased visceral branch or the aorta itself. Dialysis Access Cohort Inclusion Criteria 1. 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 at least 2 years before site initiation with the intent to cannulate the registry device.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAD Cohort: Primary Safety Outcome: Device-related Seroma or Infection | 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 or seroma classified by the registry investigator as primarily related to the registry device. |
| PAD Cohort: Primary Performance Outcome: Secondary Patency (Revascularization) | 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. |
| Aortic Aneurysm Cohort: Primary Safety Outcome: Survival Through 5 Years | Data were collected retrospectively from health registries, for up to 5 years after index procedure date | All Cause survival |
| Aortic Aneurysm Cohort: Primary Performance Outcome: Primary Patency Through 5 Years | 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. |
| Dialysis Access Cohort: Primary Safety Outcome: Device-related Infection Through 2 Years | 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. |
| Dialysis Access Cohort: Useable Access Circuit (Reported as Secondary Patency) Through 2 Years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Artery Disease Cohort: Limb Salvage Through 1 Year | 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 |
| Dialysis Access Cohort: Device-related Adverse Events Through 1 Year | 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 |
| Peripheral Artery Disease Cohort: Amputation-free Survival Through 1 Year | 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 |
| Peripheral Artery Disease Cohort: Device-related Adverse Events Through 1 Year | 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 |
| Peripheral Artery Disease Cohort: Primary Patency Through 1 Year | Data were collected retrospectively from health registries, for up to 1 year 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. |
| Peripheral Artery Disease Cohort: Device-related Infection Requiring Reoperation Through 5 Years | 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 |
| Dialysis Access Cohort: Primary Patency Through 1 Year | 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. |
Countries
France, Italy, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 145 |
| 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 | 65 |
| 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 | 146 |
| Total | 356 |
Baseline characteristics
| Characteristic | PAD Cohort | AAA Cohort | Dialysis Access Cohort | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 113 Participants | 40 Participants | 91 Participants | 244 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 25 Participants | 55 Participants | 112 Participants |
| Age, Continuous | 72.2 years STANDARD_DEVIATION 10.7 | 65.9 years STANDARD_DEVIATION 7.06 | 66.5 years STANDARD_DEVIATION 13.1 | 68.7 years STANDARD_DEVIATION 11.58 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment France | 96 participants | 65 participants | 36 participants | 197 participants |
| Region of Enrollment Italy | 46 participants | 0 participants | 54 participants | 100 participants |
| Region of Enrollment Spain | 3 participants | 0 participants | 56 participants | 59 participants |
| Sex: Female, Male Female | 39 Participants | 8 Participants | 68 Participants | 115 Participants |
| Sex: Female, Male Male | 106 Participants | 57 Participants | 78 Participants | 241 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 54 / 145 | 12 / 65 | 27 / 146 |
| other Total, other adverse events | 8 / 145 | 11 / 65 | 12 / 146 |
| serious Total, serious adverse events | 130 / 145 | 50 / 65 | 101 / 146 |
Outcome results
Primary
Aortic Aneurysm Cohort: Primary Performance Outcome: Primary Patency Through 5 Years
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.
Time frame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | Aortic Aneurysm Cohort: Primary Performance Outcome: Primary Patency Through 5 Years | 96.7 percentage of participants |
Primary
Aortic Aneurysm Cohort: Primary Safety Outcome: Survival Through 5 Years
All Cause survival
Time frame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | Aortic Aneurysm Cohort: Primary Safety Outcome: Survival Through 5 Years | 81.3 percentage of participants |
Primary
Dialysis Access Cohort: Primary Safety Outcome: Device-related Infection Through 2 Years
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.
Time frame: Data were collected retrospectively from health registries, for up to 2 years after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | Dialysis Access Cohort: Primary Safety Outcome: Device-related Infection Through 2 Years | 0 percentage of participants |
Primary
Dialysis Access Cohort: Useable Access Circuit (Reported as Secondary Patency) Through 2 Years
Patency of the study graft from the time of access creation or placement until access abandonment.
Time frame: Data were collected retrospectively from health registries, for up to 2 years after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | Dialysis Access Cohort: Useable Access Circuit (Reported as Secondary Patency) Through 2 Years | 74.3 percentage of participants |
Primary
PAD Cohort: Primary Performance Outcome: Secondary Patency (Revascularization)
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.
Time frame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | PAD Cohort: Primary Performance Outcome: Secondary Patency (Revascularization) | 75.4 percentage of participants |
Primary
PAD Cohort: Primary Safety Outcome: Device-related Seroma or Infection
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.
Time frame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | PAD Cohort: Primary Safety Outcome: Device-related Seroma or Infection | 0 percentage of participants |
Secondary
Dialysis Access Cohort: Device-related Adverse Events Through 1 Year
Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | Dialysis Access Cohort: Device-related Adverse Events Through 1 Year | 6.3 percentage of participants |
Secondary
Dialysis Access Cohort: Primary Patency Through 1 Year
Interval following intervention until the next access thrombosis or repeated intervention.
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | Dialysis Access Cohort: Primary Patency Through 1 Year | 60.8 percentage of participants |
Secondary
Peripheral Artery Disease Cohort: Amputation-free Survival Through 1 Year
Freedom from an amputation above the level of the ankle of the index limb or all cause death
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | Peripheral Artery Disease Cohort: Amputation-free Survival Through 1 Year | 81.6 percentage of participants |
Secondary
Peripheral Artery Disease Cohort: Device-related Adverse Events Through 1 Year
Any untoward medical occurrence classified by the registry investigator as primarily related to the registry device
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | Peripheral Artery Disease Cohort: Device-related Adverse Events Through 1 Year | 0 percentage of participants |
Secondary
Peripheral Artery Disease Cohort: Device-related Infection Requiring Reoperation Through 5 Years
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
Time frame: Data were collected retrospectively from health registries, for up to 5 years after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | Peripheral Artery Disease Cohort: Device-related Infection Requiring Reoperation Through 5 Years | 0 percentage of participants |
Secondary
Peripheral Artery Disease Cohort: Limb Salvage Through 1 Year
Freedom from an amputation above the level of the ankle of the index limb
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | Peripheral Artery Disease Cohort: Limb Salvage Through 1 Year | 98.3 percentage of participants |
Secondary
Peripheral Artery Disease Cohort: Primary Patency Through 1 Year
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.
Time frame: Data were collected retrospectively from health registries, for up to 1 year after index procedure date
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PAD Cohort | Peripheral Artery Disease Cohort: Primary Patency Through 1 Year | 73.4 percentage of participants |