GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft For Below-Knee Arterial Bypass (PRODIGY Study)

Conditions
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Peripheral Arterial Occlusive Disease

Intervention / Treatment
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* Device: GORE PROPATEN Vascular Graft
* Procedure: Disadvantaged Autologous Vein Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease. Patient meets the disadvantaged autologous vein criteria described in Section 4.1. Patient has a post-operative life expectancy greater than one year. Patient is at least 21 years of age. 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. Patient is willing and able to provide written, informed consent. Exclusion Criteria: Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin. Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease. Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts. 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. Patient has been previously randomized for this study. Patient has active infection in the region of graft placement.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GORE PROPATEN Vascular Graft:<br> | Device: GORE PROPATEN Vascular Graft<br>* Arterial Occlusion Bypass<br>|
| Active Comparator: Disadvantaged Autologous Vein Graft<br> | Procedure: Disadvantaged Autologous Vein Graft<br>* Arterial Occlusion Bypass<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| 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. | one month post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One month | 
| 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. | 6 months | 
| 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. | One month | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | One month | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | One month | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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 | Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care. | One month | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | One month | 
| 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. | 6 months | 
| 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. | 12 months | 
| 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. | One month |