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

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

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.

Study Overview

• Status: Terminated
• Conditions: Peripheral Arterial Occlusive Disease
• Intervention / Treatment: Device: GORE PROPATEN Vascular Graft; Procedure: Disadvantaged Autologous Vein Graft

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
    • Macon, Georgia, United States, 31201
      • Medical Center of Central Georgia
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Vascular Specialty Associates
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Bronx, New York, United States, 10467
      • Montifiore Medical Center
    • Stony Brook, New York, United States, 11794
      • Stonybrook University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital System
    • San Antonio, Texas, United States, 78205
      • Peripheral Vascular Associates
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease.
2. Patient meets the disadvantaged autologous vein criteria described in Section 4.1.
3. Patient has a post-operative life expectancy greater than one year.
4. Patient is at least 21 years of age.
5. 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.
6. Patient is willing and able to provide written, informed consent.

Exclusion Criteria:

1. Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin.
2. Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease.
3. Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts.
4. 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.
5. Patient has been previously randomized for this study.
6. Patient has active infection in the region of graft placement.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GORE PROPATEN Vascular Graft:	Device: GORE PROPATEN Vascular Graft; Arterial Occlusion Bypass
Active Comparator: Disadvantaged Autologous Vein Graft	Procedure: Disadvantaged Autologous Vein Graft; Arterial Occlusion Bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Primary Patency at 12 Months Post-procedure	Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.	12 months
Major Adverse Event Occurrences Through One Month Post-procedure	The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.	one month post-index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Primary Patency at One Month Post-procedure	Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.	One month
Number of Patients With Primary Patency at 6 Months Post-procedure	Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.	6 months
Number of Patients With Assisted Primary Patency at One Month Post-procedure	Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.	One month
Number of Patients With Assisted Primary Patency at 6 Months Post-procedure	Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.	6 months
Number of Patients With Assisted Primary Patency at 12 Months Post-procedure	Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.	12 months
Number of Patients With Secondary Patency at One Month	Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.	One month
Number of Patients With Secondary Patency at 6 Months	Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.	6 months
Number of Patients With Secondary Patency at 12 Months	Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.	12 months
Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure	Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.	One month
Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure	Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.	6 months
Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure	Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.	12 months
Patients Experiencing Major Adverse Events Through 6 Months Post-procedure	A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.	6 months
Patients Experiencing Major Adverse Events Through 12 Months Post-procedure	A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.	12 months
Number of Patients Surviving at One Month		One month
Number of Patients Surviving at 6 Months		6 months
Number of Patients Surviving at 12 Months		12 months
Number of Patients With Wound/Graft Infection Through One Month Post-procedure	Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.	One month
Number of Patients With Wound/Graft Infection Through 6 Months	Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.	6 months
Number of Patients With Wound/Graft Infection Through 12 Months	Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.	12 months
Number of Patients With Delayed Wound Healing Through One Month Post-procedure	Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.	One month
Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure	Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.	6 months
Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure	Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.	12 months
Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure	The SF-36v2 Health Survey asks 36 questions to measure health and well-being from the patient's point of view. The responses to these questions can be presented as physical component summary and mental component summary scores. An increase in score from baseline indicates an improvement in the patient's condition and a decrease in score from baseline indicates a decline in the patient's condition. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.	One month

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Richard F. Neville, MD, Georgetown University Hospital; Study Director: Jennifer Recknor, Ph.D., W. L. Gore and Associates

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: December 18, 2007
• First Submitted That Met QC Criteria: February 5, 2008
• First Posted (Estimate): February 18, 2008

Study Record Updates

• Last Update Posted (Estimate): January 12, 2012
• Last Update Submitted That Met QC Criteria: December 8, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: PPT 07-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No