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

This study has been terminated.
(Study terminated due to low enrollment)
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00617279
First received: December 18, 2007
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Occlusive Disease
Device: GORE PROPATEN Vascular Graft
Procedure: Disadvantaged Autologous Vein Graft
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft For Below-Knee Arterial Bypass (PRODIGY Study)

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Number of Patients With Primary Patency at 12 Months Post-procedure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: One month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Number of Patients Surviving at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Number of Patients Surviving at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of Patients With Wound/Graft Infection Through One Month Post-procedure [ Time Frame: One month ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: December 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617279

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

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00617279     History of Changes
Other Study ID Numbers: PPT 07-05
Study First Received: December 18, 2007
Results First Received: February 7, 2011
Last Updated: December 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014