| 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. | 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. | Posted | | Number | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
| | | Title | Denominators | Categories |
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| Patent | | | | Lost Patency | | |
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| 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. | 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. | Posted | | Number | | Participants | | One month | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Events | | one month post-index procedure | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | 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. | Posted | | Number | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | One month | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | 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. | Posted | | Number | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | 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. | Posted | | Number | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | 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. | Posted | | Number | | Participants | | One month | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | 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. | Posted | | Number | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | 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. | Posted | | Number | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | One month | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| Secondary | Number of Patients Surviving at One Month | | | Posted | | Number | | Participants | | One month | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| Secondary | Number of Patients Surviving at 6 Months | | | Posted | | Number | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| Secondary | Number of Patients Surviving at 12 Months | | | Posted | | Number | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | One month | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | One month | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | 6 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | | Posted | | Number | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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). |
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| 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. | 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. | Posted | | Mean | Standard Deviation | scores on a scale | | One month | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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). |
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