Clinical trial NCT00617279: GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Peripheral Arterial Occlusive Disease
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of Patients With Primary Patency at 12 Months Post-procedure
timeFrame: 12 months
measure: Major Adverse Event Occurrences Through One Month Post-procedure
timeFrame: one month post-index procedure
Secondary outcomes:
measure: Number of Patients With Primary Patency at One Month Post-procedure
timeFrame: One month
measure: Number of Patients With Primary Patency at 6 Months Post-procedure
timeFrame: 6 months
measure: Number of Patients With Assisted Primary Patency at One Month Post-procedure
timeFrame: One month
measure: Number of Patients With Assisted Primary Patency at 6 Months Post-procedure
timeFrame: 6 months
measure: Number of Patients With Assisted Primary Patency at 12 Months Post-procedure
timeFrame: 12 months
measure: Number of Patients With Secondary Patency at One Month
timeFrame: One month
measure: Number of Patients With Secondary Patency at 6 Months
timeFrame: 6 months
measure: Number of Patients With Secondary Patency at 12 Months
timeFrame: 12 months
measure: Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure
timeFrame: One month
measure: Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure
timeFrame: 6 months
measure: Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure
timeFrame: 12 months
measure: Patients Experiencing Major Adverse Events Through 6 Months Post-procedure
timeFrame: 6 months
measure: Patients Experiencing Major Adverse Events Through 12 Months Post-procedure
timeFrame: 12 months
measure: Number of Patients Surviving at One Month
timeFrame: One month
measure: Number of Patients Surviving at 6 Months
timeFrame: 6 months
measure: Number of Patients Surviving at 12 Months
timeFrame: 12 months
measure: Number of Patients With Wound/Graft Infection Through One Month Post-procedure
timeFrame: One month
measure: Number of Patients With Wound/Graft Infection Through 6 Months
timeFrame: 6 months
measure: Number of Patients With Wound/Graft Infection Through 12 Months
timeFrame: 12 months
measure: Number of Patients With Delayed Wound Healing Through One Month Post-procedure
timeFrame: One month
measure: Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure
timeFrame: 6 months
measure: Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure
timeFrame: 12 months
measure: Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure
timeFrame: One month
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama Medical Center
state: Alabama
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baton Rouge
country: United States
facility: Vascular Specialty Associates
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montifiore Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stonybrook University Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee medical Center
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital System
state: Texas
city: San Antonio
country: United States
facility: Peripheral Vascular Associates
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk Hospital
state: Virginia
Study officials:
affiliation: Georgetown University Hospital
name: Richard F. Neville, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: W.L.Gore & Associates
name: Jennifer Recknor, Ph.D.
role: STUDY_DIRECTOR
References: