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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

Tracking Information
First Submitted Date  ICMJE December 18, 2007
First Posted Date  ICMJE February 18, 2008
Results First Submitted Date  ICMJE February 7, 2011
Results First Posted Date  ICMJE January 12, 2012
Last Update Posted Date January 12, 2012
Study Start Date  ICMJE December 2007
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2011)
  • Number of Patients With Primary Patency at 12 Months Post-procedure [ Time Frame: 12 months ]
    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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
Primary patency at 12 months and Major adverse events through one month [ Time Frame: 12 months and 1 month post-procedure ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2011)
  • Number of Patients With Primary Patency at One Month Post-procedure [ Time Frame: One month ]
    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 [ Time Frame: 6 months ]
    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 [ Time Frame: 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.
  • Number of Patients With Assisted Primary Patency at 6 Months Post-procedure [ Time Frame: 6 months ]
    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 [ Time Frame: 12 months ]
    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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure [ Time Frame: 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.
  • Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure [ Time Frame: 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.
  • Patients Experiencing Major Adverse Events Through 6 Months Post-procedure [ Time Frame: 6 months ]
    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 [ Time Frame: 12 months ]
    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 [ Time Frame: One month ]
  • Number of Patients Surviving at 6 Months [ Time Frame: 6 months ]
  • Number of Patients Surviving at 12 Months [ Time Frame: 12 months ]
  • Number of Patients With Wound/Graft Infection Through One Month Post-procedure [ Time Frame: One month ]
    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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: One month ]
    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 [ Time Frame: 6 months ]
    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 [ Time Frame: 12 months ]
    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 [ Time Frame: One month ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2008)
Primary patency at other time points, assisted primary patency, secondary patency, limb salvage Major adverse events at other time points, survival, wound/graft infection and delayed wound healing Clinical: Quality of life (SF-36v2TM [ Time Frame: Upto 3 yrs. post-procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft
Official Title  ICMJE Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft For Below-Knee Arterial Bypass (PRODIGY Study)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Occlusive Disease
Intervention  ICMJE
  • Device: GORE PROPATEN Vascular Graft
    Arterial Occlusion Bypass
  • Procedure: Disadvantaged Autologous Vein Graft
    Arterial Occlusion Bypass
Study Arms  ICMJE
  • Active Comparator: GORE PROPATEN Vascular Graft:
    Intervention: Device: GORE PROPATEN Vascular Graft
  • Active Comparator: Disadvantaged Autologous Vein Graft
    Intervention: Procedure: Disadvantaged Autologous Vein Graft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 13, 2011)
31
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2008)
280
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00617279
Other Study ID Numbers  ICMJE PPT 07-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party W.L.Gore & Associates
Study Sponsor  ICMJE W.L.Gore & Associates
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard F. Neville, MD Georgetown University Hospital
Study Director: Jennifer Recknor, Ph.D. W. L. Gore and Associates
PRS Account W.L.Gore & Associates
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP