GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft

Phase 4TerminatedNCT00617279

W.L.Gore & Associates31 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Occlusive Disease

Interventions

GORE PROPATEN Vascular GraftDEVICE

Arterial Occlusion Bypass

Disadvantaged Autologous Vein GraftPROCEDURE

Arterial Occlusion Bypass

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (17)

University Of Alabama Medical Center

Birmingham, Alabama, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: one month post-index procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Emory University School of Medicine

Atlanta, Georgia, United States

Medical Center of Central Georgia

Macon, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Vascular Specialty Associates

Baton Rouge, Louisiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Albany Medical Center

Albany, New York, United States

Stonybrook University Medical Center

Stony Brook, New York, United States

...and 7 more locations

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: One month

Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure

Time frame: 6 months

Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure

Time frame: 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.

Time frame: 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.

Time frame: 12 months

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

Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: One month