Peripheral Arterial Occlusive Disease
Conditions
Brief summary
The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12 months.
Detailed description
Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. A disadvantaged autologous vein is defined as meeting at least one of the two following criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator; (2) Usable ipsilateral or contralateral autologous greater saphenous vein that meets any of the following criteria: (a) Diameter of less than or equal to 3.0 mm; (b) Inadequate length requiring splicing; (c) Poor quality vein that is either sclerotic or phlebitic.
Interventions
DEVICEGORE PROPATEN Vascular Graft
Arterial Occlusion Bypass
PROCEDUREDisadvantaged Autologous Vein Graft
Arterial Occlusion Bypass
Sponsors
W.L.Gore & Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease. 2. Patient meets the disadvantaged autologous vein criteria described in Section 4.1. 3. Patient has a post-operative life expectancy greater than one year. 4. Patient is at least 21 years of age. 5. Patient is able to comply with all study requirements and be available for follow-up visits at 1, 6, 12, 24 and 36-months post-procedure. 6. Patient is willing and able to provide written, informed consent.
Exclusion criteria
1. Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin. 2. Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease. 3. Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts. 4. Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure. However, inflow procedures that facilitate the bypass are permitted, as long as they are not performed at the same sitting as the bypass procedure. 5. Patient has been previously randomized for this study. 6. Patient has active infection in the region of graft placement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Primary Patency at 12 Months Post-procedure | 12 months | Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. |
| Major Adverse Event Occurrences Through One Month Post-procedure | one month post-index procedure | The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Assisted Primary Patency at One Month Post-procedure | One month | Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study. |
| Number of Patients With Assisted Primary Patency at 6 Months Post-procedure | 6 months | Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. |
| Number of Patients With Assisted Primary Patency at 12 Months Post-procedure | 12 months | Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. |
| Number of Patients With Secondary Patency at One Month | One month | Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion. |
| Number of Patients With Secondary Patency at 6 Months | 6 months | Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion. |
| Number of Patients With Secondary Patency at 12 Months | 12 months | Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion. |
| Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure | One month | Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis. |
| Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure | 6 months | Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis. |
| Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure | 12 months | Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis. |
| Patients Experiencing Major Adverse Events Through 6 Months Post-procedure | 6 months | A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. |
| Number of Patients With Primary Patency at One Month Post-procedure | One month | Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. |
| Number of Patients Surviving at One Month | One month | — |
| Number of Patients Surviving at 6 Months | 6 months | — |
| Number of Patients Surviving at 12 Months | 12 months | — |
| Number of Patients With Wound/Graft Infection Through One Month Post-procedure | One month | Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care. |
| Number of Patients With Wound/Graft Infection Through 6 Months | 6 months | Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care. |
| Number of Patients With Wound/Graft Infection Through 12 Months | 12 months | Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care. |
| Number of Patients With Delayed Wound Healing Through One Month Post-procedure | One month | Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care. |
| Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure | 6 months | Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care. |
| Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure | 12 months | Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care. |
| Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure | One month | The SF-36v2 Health Survey asks 36 questions to measure health and well-being from the patient's point of view. The responses to these questions can be presented as physical component summary and mental component summary scores. An increase in score from baseline indicates an improvement in the patient's condition and a decrease in score from baseline indicates a decline in the patient's condition. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10. |
| Patients Experiencing Major Adverse Events Through 12 Months Post-procedure | 12 months | A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. |
| Number of Patients With Primary Patency at 6 Months Post-procedure | 6 months | Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. |
Countries
United States
Participant flow
Recruitment details
Patients requiring below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease were recruited. Recruitment commenced December 2007 and was terminated by the Sponsor January 2010 due to slow enrollment. Investigative site locations included university hospitals and other medical clinics.
Participants by arm
| Arm | Count |
|---|---|
| GORE PROPATEN Vascular Graft: Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. | 14 |
| Disadvantaged Autologous Vein Graft Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic). | 17 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Graft abandonment | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Study terminated by Sponsor | 10 | 15 |
Baseline characteristics
| Characteristic | GORE PROPATEN Vascular Graft: | Total | Disadvantaged Autologous Vein Graft |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 17 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 14 Participants | 7 Participants |
| Age Continuous | 65 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 9 | 68 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 14 participants | 31 participants | 17 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 19 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 14 | 3 / 17 |
| serious Total, serious adverse events | 4 / 14 | 2 / 17 |
Outcome results
Primary
Major Adverse Event Occurrences Through One Month Post-procedure
The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.
Time frame: one month post-index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GORE PROPATEN Vascular Graft: | Major Adverse Event Occurrences Through One Month Post-procedure | 4 Events |
| Disadvantaged Autologous Vein Graft | Major Adverse Event Occurrences Through One Month Post-procedure | 5 Events |
Primary
Number of Patients With Primary Patency at 12 Months Post-procedure
Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
Time frame: 12 months
Population: The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that many enrolled patients did not have their 12 month follow-up visit prior to the termination of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Primary Patency at 12 Months Post-procedure | Patent | 2 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Primary Patency at 12 Months Post-procedure | Lost Patency | 4 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Primary Patency at 12 Months Post-procedure | Patent | 3 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Primary Patency at 12 Months Post-procedure | Lost Patency | 4 Participants |
Secondary
Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure
The SF-36v2 Health Survey asks 36 questions to measure health and well-being from the patient's point of view. The responses to these questions can be presented as physical component summary and mental component summary scores. An increase in score from baseline indicates an improvement in the patient's condition and a decrease in score from baseline indicates a decline in the patient's condition. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.
Time frame: One month
Population: The number of patients analyzed at 1 month does not equal the number of patients originally enrolled into the study, due to the fact that a number of enrolled patients did not have (or failed to attend) their 1 month follow-up visit prior to the termination of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure | One month change from Baseline Mental Score | 2.9 scores on a scale | Standard Deviation 6.61 |
| GORE PROPATEN Vascular Graft: | Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure | One month change from Baseline Physical Score | -3.6 scores on a scale | Standard Deviation 8.67 |
| Disadvantaged Autologous Vein Graft | Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure | One month change from Baseline Mental Score | 2.2 scores on a scale | Standard Deviation 8.77 |
| Disadvantaged Autologous Vein Graft | Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure | One month change from Baseline Physical Score | 4.4 scores on a scale | Standard Deviation 10.44 |
Secondary
Number of Patients Surviving at 12 Months
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients Surviving at 12 Months | Survived | 13 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients Surviving at 12 Months | Did not survive | 1 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients Surviving at 12 Months | Did not survive | 2 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients Surviving at 12 Months | Survived | 15 Participants |
Secondary
Number of Patients Surviving at 6 Months
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients Surviving at 6 Months | Did not survive | 1 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients Surviving at 6 Months | Survived | 13 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients Surviving at 6 Months | Survived | 16 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients Surviving at 6 Months | Did not survive | 1 Participants |
Secondary
Number of Patients Surviving at One Month
Time frame: One month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients Surviving at One Month | Survived | 14 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients Surviving at One Month | Did not survive | 0 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients Surviving at One Month | Survived | 17 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients Surviving at One Month | Did not survive | 0 Participants |
Secondary
Number of Patients With Assisted Primary Patency at 12 Months Post-procedure
Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.
Time frame: 12 months
Population: The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Assisted Primary Patency at 12 Months Post-procedure | Patent | 2 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Assisted Primary Patency at 12 Months Post-procedure | Lost patency | 4 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Assisted Primary Patency at 12 Months Post-procedure | Patent | 3 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Assisted Primary Patency at 12 Months Post-procedure | Lost patency | 3 Participants |
Secondary
Number of Patients With Assisted Primary Patency at 6 Months Post-procedure
Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.
Time frame: 6 months
Population: The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Assisted Primary Patency at 6 Months Post-procedure | Patent | 5 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Assisted Primary Patency at 6 Months Post-procedure | Lost patency | 3 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Assisted Primary Patency at 6 Months Post-procedure | Patent | 5 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Assisted Primary Patency at 6 Months Post-procedure | Lost patency | 3 Participants |
Secondary
Number of Patients With Assisted Primary Patency at One Month Post-procedure
Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.
Time frame: One month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Assisted Primary Patency at One Month Post-procedure | Patency | 5 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Assisted Primary Patency at One Month Post-procedure | Lost Patency | 3 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Assisted Primary Patency at One Month Post-procedure | Patency | 8 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Assisted Primary Patency at One Month Post-procedure | Lost Patency | 2 Participants |
Secondary
Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure
Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure | Delayed wound healing | 1 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure | No delayed wound healing | 13 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure | Delayed wound healing | 1 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure | No delayed wound healing | 16 Participants |
Secondary
Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure
Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure | Delayed wound healing | 1 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure | No delayed wound healing | 13 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure | Delayed wound healing | 1 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure | No delayed wound healing | 16 Participants |
Secondary
Number of Patients With Delayed Wound Healing Through One Month Post-procedure
Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time frame: One month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Delayed Wound Healing Through One Month Post-procedure | Delayed wound healing | 0 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Delayed Wound Healing Through One Month Post-procedure | No delayed wound healing | 14 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Delayed Wound Healing Through One Month Post-procedure | Delayed wound healing | 1 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Delayed Wound Healing Through One Month Post-procedure | No delayed wound healing | 16 Participants |
Secondary
Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure
Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure | Limb salvaged | 13 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure | Limb not salvaged | 1 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure | Limb salvaged | 17 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure | Limb not salvaged | 0 Participants |
Secondary
Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure
Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure | Limb salvaged | 13 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure | Limb not salvaged | 1 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure | Limb salvaged | 17 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure | Limb not salvaged | 0 Participants |
Secondary
Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure
Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
Time frame: One month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure | Limb salvaged | 13 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure | Limb not salvaged | 1 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure | Limb salvaged | 17 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure | Limb not salvaged | 0 Participants |
Secondary
Number of Patients With Primary Patency at 6 Months Post-procedure
Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
Time frame: 6 months
Population: The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Primary Patency at 6 Months Post-procedure | Patent | 5 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Primary Patency at 6 Months Post-procedure | Lost patency | 3 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Primary Patency at 6 Months Post-procedure | Patent | 5 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Primary Patency at 6 Months Post-procedure | Lost patency | 4 Participants |
Secondary
Number of Patients With Primary Patency at One Month Post-procedure
Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
Time frame: One month
Population: The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Primary Patency at One Month Post-procedure | Lost Patency | 2 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Primary Patency at One Month Post-procedure | Patent | 8 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Primary Patency at One Month Post-procedure | Patent | 5 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Primary Patency at One Month Post-procedure | Lost Patency | 3 Participants |
Secondary
Number of Patients With Secondary Patency at 12 Months
Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
Time frame: 12 months
Population: The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Secondary Patency at 12 Months | Patent | 2 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Secondary Patency at 12 Months | Lost patency | 2 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Secondary Patency at 12 Months | Patent | 3 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Secondary Patency at 12 Months | Lost patency | 3 Participants |
Secondary
Number of Patients With Secondary Patency at 6 Months
Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
Time frame: 6 months
Population: The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Secondary Patency at 6 Months | Patency | 5 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Secondary Patency at 6 Months | Lost patency | 2 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Secondary Patency at 6 Months | Patency | 5 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Secondary Patency at 6 Months | Lost patency | 3 Participants |
Secondary
Number of Patients With Secondary Patency at One Month
Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
Time frame: One month
Population: The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Secondary Patency at One Month | Patent | 8 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Secondary Patency at One Month | Lost patency | 2 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Secondary Patency at One Month | Patent | 5 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Secondary Patency at One Month | Lost patency | 3 Participants |
Secondary
Number of Patients With Wound/Graft Infection Through 12 Months
Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Wound/Graft Infection Through 12 Months | Infected | 2 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Wound/Graft Infection Through 12 Months | Not infected | 12 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Wound/Graft Infection Through 12 Months | Infected | 1 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Wound/Graft Infection Through 12 Months | Not infected | 16 Participants |
Secondary
Number of Patients With Wound/Graft Infection Through 6 Months
Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Wound/Graft Infection Through 6 Months | Infected | 2 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Wound/Graft Infection Through 6 Months | Not infected | 12 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Wound/Graft Infection Through 6 Months | Infected | 1 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Wound/Graft Infection Through 6 Months | Not infected | 16 Participants |
Secondary
Number of Patients With Wound/Graft Infection Through One Month Post-procedure
Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time frame: One month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Number of Patients With Wound/Graft Infection Through One Month Post-procedure | Infected | 2 Participants |
| GORE PROPATEN Vascular Graft: | Number of Patients With Wound/Graft Infection Through One Month Post-procedure | Not infected | 12 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Wound/Graft Infection Through One Month Post-procedure | Not infected | 16 Participants |
| Disadvantaged Autologous Vein Graft | Number of Patients With Wound/Graft Infection Through One Month Post-procedure | Infected | 1 Participants |
Secondary
Patients Experiencing Major Adverse Events Through 12 Months Post-procedure
A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Patients Experiencing Major Adverse Events Through 12 Months Post-procedure | Major Adverse Event occurred | 4 Participants |
| GORE PROPATEN Vascular Graft: | Patients Experiencing Major Adverse Events Through 12 Months Post-procedure | Major Adverse Event did not occur | 10 Participants |
| Disadvantaged Autologous Vein Graft | Patients Experiencing Major Adverse Events Through 12 Months Post-procedure | Major Adverse Event occurred | 2 Participants |
| Disadvantaged Autologous Vein Graft | Patients Experiencing Major Adverse Events Through 12 Months Post-procedure | Major Adverse Event did not occur | 15 Participants |
Secondary
Patients Experiencing Major Adverse Events Through 6 Months Post-procedure
A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GORE PROPATEN Vascular Graft: | Patients Experiencing Major Adverse Events Through 6 Months Post-procedure | Major Adverse Event occurred | 3 Participants |
| GORE PROPATEN Vascular Graft: | Patients Experiencing Major Adverse Events Through 6 Months Post-procedure | Major Adverse Event did not occur | 11 Participants |
| Disadvantaged Autologous Vein Graft | Patients Experiencing Major Adverse Events Through 6 Months Post-procedure | Major Adverse Event occurred | 2 Participants |
| Disadvantaged Autologous Vein Graft | Patients Experiencing Major Adverse Events Through 6 Months Post-procedure | Major Adverse Event did not occur | 15 Participants |