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GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft (PRODIGY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00617279
Recruitment Status : Terminated (Study terminated due to low enrollment)
First Posted : February 18, 2008
Results First Posted : January 12, 2012
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peripheral Arterial Occlusive Disease
Interventions Device: GORE PROPATEN Vascular Graft
Procedure: Disadvantaged Autologous Vein Graft
Enrollment 31
Recruitment Details Patients requiring below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease were recruited. Recruitment commenced December 2007 and was terminated by the Sponsor January 2010 due to slow enrollment. Investigative site locations included university hospitals and other medical clinics.
Pre-assignment Details  
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description 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. 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).
Period Title: Overall Study
Started 14 17
Completed 0 0
Not Completed 14 17
Reason Not Completed
Study terminated by Sponsor             10             15
Graft abandonment             2             0
Lost to Follow-up             1             0
Death             1             2
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 14 17 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  50.0%
7
  41.2%
14
  45.2%
>=65 years
7
  50.0%
10
  58.8%
17
  54.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 17 participants 31 participants
65  (10) 68  (8) 67  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 17 participants 31 participants
Female
7
  50.0%
5
  29.4%
12
  38.7%
Male
7
  50.0%
12
  70.6%
19
  61.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 17 participants 31 participants
14 17 31
1.Primary Outcome
Title Number of Patients With Primary Patency at 12 Months Post-procedure
Hide Description Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that many enrolled patients did not have their 12 month follow-up visit prior to the termination of the study.
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 6 7
Measure Type: Number
Unit of Measure: Participants
Patent 2 3
Lost Patency 4 4
2.Primary Outcome
Title Major Adverse Event Occurrences Through One Month Post-procedure
Hide Description The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.
Time Frame one month post-index procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Events
4 5
3.Secondary Outcome
Title Number of Patients With Primary Patency at One Month Post-procedure
Hide Description Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
Time Frame One month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 8
Measure Type: Number
Unit of Measure: Participants
Patent 8 5
Lost Patency 2 3
4.Secondary Outcome
Title Number of Patients With Primary Patency at 6 Months Post-procedure
Hide Description Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: Participants
Patent 5 5
Lost patency 3 4
5.Secondary Outcome
Title Number of Patients With Assisted Primary Patency at One Month Post-procedure
Hide Description Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.
Time Frame One month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 8 10
Measure Type: Number
Unit of Measure: Participants
Patency 5 8
Lost Patency 3 2
6.Secondary Outcome
Title Number of Patients With Assisted Primary Patency at 6 Months Post-procedure
Hide Description Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 8 8
Measure Type: Number
Unit of Measure: Participants
Patent 5 5
Lost patency 3 3
7.Secondary Outcome
Title Number of Patients With Assisted Primary Patency at 12 Months Post-procedure
Hide Description Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: Participants
Patent 2 3
Lost patency 4 3
8.Secondary Outcome
Title Number of Patients With Secondary Patency at One Month
Hide Description Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
Time Frame One month
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 8
Measure Type: Number
Unit of Measure: Participants
Patent 8 5
Lost patency 2 3
9.Secondary Outcome
Title Number of Patients With Secondary Patency at 6 Months
Hide Description Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 7 8
Measure Type: Number
Unit of Measure: Participants
Patency 5 5
Lost patency 2 3
10.Secondary Outcome
Title Number of Patients With Secondary Patency at 12 Months
Hide Description Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 4 6
Measure Type: Number
Unit of Measure: Participants
Patent 2 3
Lost patency 2 3
11.Secondary Outcome
Title Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure
Hide Description Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
Time Frame One month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Limb salvaged 13 17
Limb not salvaged 1 0
12.Secondary Outcome
Title Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure
Hide Description Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Limb salvaged 13 17
Limb not salvaged 1 0
13.Secondary Outcome
Title Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure
Hide Description Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Limb salvaged 13 17
Limb not salvaged 1 0
14.Secondary Outcome
Title Patients Experiencing Major Adverse Events Through 6 Months Post-procedure
Hide Description A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Major Adverse Event occurred 3 2
Major Adverse Event did not occur 11 15
15.Secondary Outcome
Title Patients Experiencing Major Adverse Events Through 12 Months Post-procedure
Hide Description A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Major Adverse Event occurred 4 2
Major Adverse Event did not occur 10 15
16.Secondary Outcome
Title Number of Patients Surviving at One Month
Hide Description [Not Specified]
Time Frame One month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Survived 14 17
Did not survive 0 0
17.Secondary Outcome
Title Number of Patients Surviving at 6 Months
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Survived 13 16
Did not survive 1 1
18.Secondary Outcome
Title Number of Patients Surviving at 12 Months
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Survived 13 15
Did not survive 1 2
19.Secondary Outcome
Title Number of Patients With Wound/Graft Infection Through One Month Post-procedure
Hide Description Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time Frame One month
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[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Infected 2 1
Not infected 12 16
20.Secondary Outcome
Title Number of Patients With Wound/Graft Infection Through 6 Months
Hide Description Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Infected 2 1
Not infected 12 16
21.Secondary Outcome
Title Number of Patients With Wound/Graft Infection Through 12 Months
Hide Description Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Infected 2 1
Not infected 12 16
22.Secondary Outcome
Title Number of Patients With Delayed Wound Healing Through One Month Post-procedure
Hide Description Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time Frame One month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Delayed wound healing 0 1
No delayed wound healing 14 16
23.Secondary Outcome
Title Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure
Hide Description Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Delayed wound healing 1 1
No delayed wound healing 13 16
24.Secondary Outcome
Title Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure
Hide Description Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 17
Measure Type: Number
Unit of Measure: Participants
Delayed wound healing 1 1
No delayed wound healing 13 16
25.Secondary Outcome
Title Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure
Hide Description The SF-36v2 Health Survey asks 36 questions to measure health and well-being from the patient's point of view. The responses to these questions can be presented as physical component summary and mental component summary scores. An increase in score from baseline indicates an improvement in the patient's condition and a decrease in score from baseline indicates a decline in the patient's condition. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.
Time Frame One month
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Hide Analysis Population Description
The number of patients analyzed at 1 month does not equal the number of patients originally enrolled into the study, due to the fact that a number of enrolled patients did not have (or failed to attend) their 1 month follow-up visit prior to the termination of the study.
Arm/Group Title GORE PROPATEN Vascular Graft: Disadvantaged Autologous Vein Graft
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: scores on a scale
One month change from Baseline Mental Score 2.9  (6.61) 2.2  (8.77)
One month change from Baseline Physical Score -3.6  (8.67) 4.4  (10.44)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GORE PROPATEN Vascular Graft Disadvantaged Autologous Vein Graft
Hide Arm/Group Description GORE PROPATEN Vascular Graft Disadvantaged Autologous Vein Graft
All-Cause Mortality
GORE PROPATEN Vascular Graft Disadvantaged Autologous Vein Graft
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
GORE PROPATEN Vascular Graft Disadvantaged Autologous Vein Graft
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/14 (28.57%)      2/17 (11.76%)    
Cardiac disorders     
Myocardial infarction  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Infections and infestations     
Graft infection  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Injury, poisoning and procedural complications     
Esophageal tear  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Postoperative wound infection  1  0/14 (0.00%)  0 1/17 (5.88%)  2
Vascular graft occlusion  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Nervous system disorders     
Cerebral infarction  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Surgical and medical procedures     
Below knee amputation  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Foot amputation  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Transmetatarsal amputation  1  0/14 (0.00%)  0 1/17 (5.88%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GORE PROPATEN Vascular Graft Disadvantaged Autologous Vein Graft
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/14 (28.57%)      3/17 (17.65%)    
Cardiac disorders     
Myocardial infarction  1  0/14 (0.00%)  0 1/17 (5.88%)  1
General disorders     
Edema  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Wound healing delayed  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Infections and infestations     
Sepsis NOS  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Injury, poisoning and procedural complications     
Incision site erythema  1  0/14 (0.00%)  0 1/17 (5.88%)  1
Incision site hematoma  1  0/14 (0.00%)  0 1/17 (5.88%)  1
Intraoperative bleeding  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Post procedural swelling  1  0/14 (0.00%)  0 1/17 (5.88%)  1
Wound dehiscence  1  0/14 (0.00%)  0 1/17 (5.88%)  1
Skin and subcutaneous tissue disorders     
Cellulitis of leg  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Vascular disorders     
Claudication  1  1/14 (7.14%)  1 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDra Version 13.1
The study was terminated prior to completion of enrollment. The primary patency and secondary endpoints were not calculated due to the paucity of data.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chad Badorek, Clinical Study Manager
Organization: W. L. Gore & Associates, Inc.
Phone: 928.864.3486
EMail: cbadorek@wlgore.com
Layout table for additonal information
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00617279    
Other Study ID Numbers: PPT 07-05
First Submitted: December 18, 2007
First Posted: February 18, 2008
Results First Submitted: February 7, 2011
Results First Posted: January 12, 2012
Last Update Posted: January 12, 2012