Back to resultsGORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft (PRODIGY)
Primary Purpose
Peripheral Arterial Occlusive Disease
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
GORE PROPATEN Vascular Graft
Disadvantaged Autologous Vein Graft
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Occlusive Disease
Eligibility Criteria
Inclusion Criteria:
- Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease.
- Patient meets the disadvantaged autologous vein criteria described in Section 4.1.
- Patient has a post-operative life expectancy greater than one year.
- Patient is at least 21 years of age.
- Patient is able to comply with all study requirements and be available for follow-up visits at 1, 6, 12, 24 and 36-months post-procedure.
- Patient is willing and able to provide written, informed consent.
Exclusion Criteria:
- Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin.
- Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease.
- Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts.
- Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure. However, inflow procedures that facilitate the bypass are permitted, as long as they are not performed at the same sitting as the bypass procedure.
- Patient has been previously randomized for this study.
- Patient has active infection in the region of graft placement.
Sites / Locations
- University Of Alabama Medical Center
- Georgetown University Hospital
- Emory University School of Medicine
- Medical Center of Central Georgia
- University of Chicago
- Vascular Specialty Associates
- University of Maryland Medical Center
- Brigham and Women's Hospital
- Albany Medical Center
- Montifiore Medical Center
- Stonybrook University Medical Center
- Cleveland Clinic
- Greenville Hospital System
- University of Tennessee medical Center
- The Methodist Hospital System
- Peripheral Vascular Associates
- Sentara Norfolk Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
GORE PROPATEN Vascular Graft:
Disadvantaged Autologous Vein Graft
Arm Description
Outcomes
Primary Outcome Measures
Number of Patients With Primary Patency at 12 Months Post-procedure
Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
Major Adverse Event Occurrences Through One Month Post-procedure
The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.
Secondary Outcome Measures
Number of Patients With Primary Patency at One Month Post-procedure
Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
Number of Patients With Primary Patency at 6 Months Post-procedure
Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
Number of Patients With Assisted Primary Patency at One Month Post-procedure
Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.
Number of Patients With Assisted Primary Patency at 6 Months Post-procedure
Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.
Number of Patients With Assisted Primary Patency at 12 Months Post-procedure
Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.
Number of Patients With Secondary Patency at One Month
Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
Number of Patients With Secondary Patency at 6 Months
Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
Number of Patients With Secondary Patency at 12 Months
Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure
Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure
Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure
Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
Patients Experiencing Major Adverse Events Through 6 Months Post-procedure
A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
Patients Experiencing Major Adverse Events Through 12 Months Post-procedure
A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
Number of Patients Surviving at One Month
Number of Patients Surviving at 6 Months
Number of Patients Surviving at 12 Months
Number of Patients With Wound/Graft Infection Through One Month Post-procedure
Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
Number of Patients With Wound/Graft Infection Through 6 Months
Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
Number of Patients With Wound/Graft Infection Through 12 Months
Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
Number of Patients With Delayed Wound Healing Through One Month Post-procedure
Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure
Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure
Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure
The SF-36v2 Health Survey asks 36 questions to measure health and well-being from the patient's point of view. The responses to these questions can be presented as physical component summary and mental component summary scores. An increase in score from baseline indicates an improvement in the patient's condition and a decrease in score from baseline indicates a decline in the patient's condition. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.
Full Information
NCT ID
NCT00617279
First Posted
December 18, 2007
Last Updated
December 8, 2011
Sponsor
W.L.Gore & Associates
1. Study Identification
Unique Protocol Identification Number
NCT00617279
Brief Title
GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft
Acronym
PRODIGY
Official Title
Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft For Below-Knee Arterial Bypass (PRODIGY Study)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to low enrollment
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12 months.
Detailed Description
Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. A disadvantaged autologous vein is defined as meeting at least one of the two following criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator; (2) Usable ipsilateral or contralateral autologous greater saphenous vein that meets any of the following criteria: (a) Diameter of less than or equal to 3.0 mm; (b) Inadequate length requiring splicing; (c) Poor quality vein that is either sclerotic or phlebitic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GORE PROPATEN Vascular Graft:
Arm Type
Active Comparator
Arm Title
Disadvantaged Autologous Vein Graft
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
GORE PROPATEN Vascular Graft
Intervention Description
Arterial Occlusion Bypass
Intervention Type
Procedure
Intervention Name(s)
Disadvantaged Autologous Vein Graft
Intervention Description
Arterial Occlusion Bypass
Primary Outcome Measure Information:
Title
Number of Patients With Primary Patency at 12 Months Post-procedure
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
Title
Major Adverse Event Occurrences Through One Month Post-procedure
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
Secondary Outcome Measure Information:
Title
Number of Patients With Primary Patency at One Month Post-procedure
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
Title
Number of Patients With Primary Patency at 6 Months Post-procedure
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
Title
Number of Patients With Assisted Primary Patency at One Month Post-procedure
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
Title
Number of Patients With Assisted Primary Patency at 6 Months Post-procedure
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
Title
Number of Patients With Assisted Primary Patency at 12 Months Post-procedure
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
Title
Number of Patients With Secondary Patency at One Month
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
Title
Number of Patients With Secondary Patency at 6 Months
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
Title
Number of Patients With Secondary Patency at 12 Months
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
Title
Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure
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
Title
Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure
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
Title
Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure
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
Title
Patients Experiencing Major Adverse Events Through 6 Months Post-procedure
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
Title
Patients Experiencing Major Adverse Events Through 12 Months Post-procedure
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
Title
Number of Patients Surviving at One Month
Time Frame
One month
Title
Number of Patients Surviving at 6 Months
Time Frame
6 months
Title
Number of Patients Surviving at 12 Months
Time Frame
12 months
Title
Number of Patients With Wound/Graft Infection Through One Month Post-procedure
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
Title
Number of Patients With Wound/Graft Infection Through 6 Months
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
Title
Number of Patients With Wound/Graft Infection Through 12 Months
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
Title
Number of Patients With Delayed Wound Healing Through One Month Post-procedure
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
Title
Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure
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
Title
Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure
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
Title
Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease.
Patient meets the disadvantaged autologous vein criteria described in Section 4.1.
Patient has a post-operative life expectancy greater than one year.
Patient is at least 21 years of age.
Patient is able to comply with all study requirements and be available for follow-up visits at 1, 6, 12, 24 and 36-months post-procedure.
Patient is willing and able to provide written, informed consent.
Exclusion Criteria:
Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin.
Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease.
Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts.
Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure. However, inflow procedures that facilitate the bypass are permitted, as long as they are not performed at the same sitting as the bypass procedure.
Patient has been previously randomized for this study.
Patient has active infection in the region of graft placement.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard F. Neville, MD
Organizational Affiliation
Georgetown University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Recknor, Ph.D.
Organizational Affiliation
W.L.Gore & Associates
Official's Role
Study Director
Facility Information:
Facility Name
University Of Alabama Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Medical Center of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Vascular Specialty Associates
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montifiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Stonybrook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
University of Tennessee medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
The Methodist Hospital System
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Peripheral Vascular Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Sentara Norfolk Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft
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