Trial Outcomes & Findings for GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft (NCT NCT00617279)

NCT ID: NCT00617279

Last Updated: 2012-01-12

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2012-01-12

Participant Flow

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.

Participant milestones

Measure	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.	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).
Overall Study STARTED	14	17
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	14	17

Reasons for withdrawal

Measure	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.	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).
Overall Study Study terminated by Sponsor	10	15
Overall Study Graft abandonment	2	0
Overall Study Lost to Follow-up	1	0
Overall Study Death	1	2

Baseline Characteristics

GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft

Baseline characteristics by cohort

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Age Continuous	65 years STANDARD_DEVIATION 10 • n=5 Participants	68 years STANDARD_DEVIATION 8 • n=7 Participants	67 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	17 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=6 Participants 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.	Disadvantaged Autologous Vein Graft n=7 Participants 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).
Number of Patients With Primary Patency at 12 Months Post-procedure Patent	2 Participants	3 Participants
Number of Patients With Primary Patency at 12 Months Post-procedure Lost Patency	4 Participants	4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Major Adverse Event Occurrences Through One Month Post-procedure	4 Events	5 Events

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=10 Participants 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.	Disadvantaged Autologous Vein Graft n=8 Participants 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).
Number of Patients With Primary Patency at One Month Post-procedure Patent	8 Participants	5 Participants
Number of Patients With Primary Patency at One Month Post-procedure Lost Patency	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=8 Participants 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.	Disadvantaged Autologous Vein Graft n=9 Participants 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).
Number of Patients With Primary Patency at 6 Months Post-procedure Patent	5 Participants	5 Participants
Number of Patients With Primary Patency at 6 Months Post-procedure Lost patency	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=8 Participants 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.	Disadvantaged Autologous Vein Graft n=10 Participants 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).
Number of Patients With Assisted Primary Patency at One Month Post-procedure Patency	5 Participants	8 Participants
Number of Patients With Assisted Primary Patency at One Month Post-procedure Lost Patency	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=8 Participants 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.	Disadvantaged Autologous Vein Graft n=8 Participants 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).
Number of Patients With Assisted Primary Patency at 6 Months Post-procedure Patent	5 Participants	5 Participants
Number of Patients With Assisted Primary Patency at 6 Months Post-procedure Lost patency	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=6 Participants 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.	Disadvantaged Autologous Vein Graft n=6 Participants 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).
Number of Patients With Assisted Primary Patency at 12 Months Post-procedure Lost patency	4 Participants	3 Participants
Number of Patients With Assisted Primary Patency at 12 Months Post-procedure Patent	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=10 Participants 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.	Disadvantaged Autologous Vein Graft n=8 Participants 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).
Number of Patients With Secondary Patency at One Month Patent	8 Participants	5 Participants
Number of Patients With Secondary Patency at One Month Lost patency	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=7 Participants 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.	Disadvantaged Autologous Vein Graft n=8 Participants 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).
Number of Patients With Secondary Patency at 6 Months Patency	5 Participants	5 Participants
Number of Patients With Secondary Patency at 6 Months Lost patency	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=4 Participants 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.	Disadvantaged Autologous Vein Graft n=6 Participants 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).
Number of Patients With Secondary Patency at 12 Months Patent	2 Participants	3 Participants
Number of Patients With Secondary Patency at 12 Months Lost patency	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure Limb salvaged	13 Participants	17 Participants
Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure Limb not salvaged	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure Limb salvaged	13 Participants	17 Participants
Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure Limb not salvaged	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure Limb salvaged	13 Participants	17 Participants
Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure Limb not salvaged	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Patients Experiencing Major Adverse Events Through 6 Months Post-procedure Major Adverse Event occurred	3 Participants	2 Participants
Patients Experiencing Major Adverse Events Through 6 Months Post-procedure Major Adverse Event did not occur	11 Participants	15 Participants

SECONDARY outcome

Timeframe: 12 months

A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Patients Experiencing Major Adverse Events Through 12 Months Post-procedure Major Adverse Event occurred	4 Participants	2 Participants
Patients Experiencing Major Adverse Events Through 12 Months Post-procedure Major Adverse Event did not occur	10 Participants	15 Participants

SECONDARY outcome

Timeframe: One month

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients Surviving at One Month Survived	14 Participants	17 Participants
Number of Patients Surviving at One Month Did not survive	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients Surviving at 6 Months Survived	13 Participants	16 Participants
Number of Patients Surviving at 6 Months Did not survive	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients Surviving at 12 Months Survived	13 Participants	15 Participants
Number of Patients Surviving at 12 Months Did not survive	1 Participants	2 Participants

SECONDARY outcome

Timeframe: One month

Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients With Wound/Graft Infection Through One Month Post-procedure Infected	2 Participants	1 Participants
Number of Patients With Wound/Graft Infection Through One Month Post-procedure Not infected	12 Participants	16 Participants

SECONDARY outcome

Timeframe: 6 months

Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients With Wound/Graft Infection Through 6 Months Infected	2 Participants	1 Participants
Number of Patients With Wound/Graft Infection Through 6 Months Not infected	12 Participants	16 Participants

SECONDARY outcome

Timeframe: 12 months

Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients With Wound/Graft Infection Through 12 Months Infected	2 Participants	1 Participants
Number of Patients With Wound/Graft Infection Through 12 Months Not infected	12 Participants	16 Participants

SECONDARY outcome

Timeframe: One month

Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients With Delayed Wound Healing Through One Month Post-procedure Delayed wound healing	0 Participants	1 Participants
Number of Patients With Delayed Wound Healing Through One Month Post-procedure No delayed wound healing	14 Participants	16 Participants

SECONDARY outcome

Timeframe: 6 months

Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure Delayed wound healing	1 Participants	1 Participants
Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure No delayed wound healing	13 Participants	16 Participants

SECONDARY outcome

Timeframe: 12 months

Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=14 Participants 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.	Disadvantaged Autologous Vein Graft n=17 Participants 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).
Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure Delayed wound healing	1 Participants	1 Participants
Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure No delayed wound healing	13 Participants	16 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	GORE PROPATEN Vascular Graft: n=10 Participants 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.	Disadvantaged Autologous Vein Graft n=8 Participants 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).
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	2.2 scores on a scale Standard Deviation 8.77
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	4.4 scores on a scale Standard Deviation 10.44

Adverse Events

GORE PROPATEN Vascular Graft

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Disadvantaged Autologous Vein Graft

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	GORE PROPATEN Vascular Graft n=14 participants at risk GORE PROPATEN Vascular Graft	Disadvantaged Autologous Vein Graft n=17 participants at risk Disadvantaged Autologous Vein Graft
Surgical and medical procedures Below knee amputation	7.1% 1/14 • Number of events 1	0.00% 0/17
Nervous system disorders Cerebral infarction	7.1% 1/14 • Number of events 1	0.00% 0/17
Injury, poisoning and procedural complications Esophageal tear	7.1% 1/14 • Number of events 1	0.00% 0/17
Surgical and medical procedures Foot amputation	7.1% 1/14 • Number of events 1	0.00% 0/17
Infections and infestations Graft infection	7.1% 1/14 • Number of events 1	0.00% 0/17
Cardiac disorders Myocardial infarction	7.1% 1/14 • Number of events 1	0.00% 0/17
Injury, poisoning and procedural complications Postoperative wound infection	0.00% 0/14	5.9% 1/17 • Number of events 2
Surgical and medical procedures Transmetatarsal amputation	0.00% 0/14	5.9% 1/17 • Number of events 1
Injury, poisoning and procedural complications Vascular graft occlusion	7.1% 1/14 • Number of events 1	0.00% 0/17

Other adverse events

Measure	GORE PROPATEN Vascular Graft n=14 participants at risk GORE PROPATEN Vascular Graft	Disadvantaged Autologous Vein Graft n=17 participants at risk Disadvantaged Autologous Vein Graft
Skin and subcutaneous tissue disorders Cellulitis of leg	7.1% 1/14 • Number of events 1	0.00% 0/17
Vascular disorders Claudication	7.1% 1/14 • Number of events 1	0.00% 0/17
General disorders Edema	7.1% 1/14 • Number of events 1	0.00% 0/17
Injury, poisoning and procedural complications Incision site erythema	0.00% 0/14	5.9% 1/17 • Number of events 1
Injury, poisoning and procedural complications Incision site hematoma	0.00% 0/14	5.9% 1/17 • Number of events 1
Injury, poisoning and procedural complications Intraoperative bleeding	7.1% 1/14 • Number of events 1	0.00% 0/17
Cardiac disorders Myocardial infarction	0.00% 0/14	5.9% 1/17 • Number of events 1
Injury, poisoning and procedural complications Post procedural swelling	0.00% 0/14	5.9% 1/17 • Number of events 1
Infections and infestations Sepsis NOS	7.1% 1/14 • Number of events 1	0.00% 0/17
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/14	5.9% 1/17 • Number of events 1
General disorders Wound healing delayed	7.1% 1/14 • Number of events 1	0.00% 0/17

Additional Information

Chad Badorek, Clinical Study Manager

W. L. Gore & Associates, Inc.

Phone: 928.864.3486

Email: cbadorek@wlgore.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60