GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft

Peripheral Arterial Occlusive Disease Clinical Trial

— PRODIGY  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00617279
• Other study ID #: PPT 07-05
• Status: Terminated
• Phase: Phase 4
• First received: December 18, 2007
• Last updated: December 8, 2011
• Start date: December 2007
• Est. completion date: February 2010

Study information

• Verified date: December 2011
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Intervention

Device:
• GORE PROPATEN Vascular Graft
Arterial Occlusion Bypass

Procedure:
• Disadvantaged Autologous Vein Graft
Arterial Occlusion Bypass

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Vascular Specialty Associates	Baton Rouge	Louisiana
United States	University Of Alabama Medical Center	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Montifiore Medical Center	Bronx	New York
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Greenville Hospital System	Greenville	South Carolina
United States	The Methodist Hospital System	Houston	Texas
United States	University of Tennessee medical Center	Knoxville	Tennessee
United States	Medical Center of Central Georgia	Macon	Georgia
United States	Sentara Norfolk Hospital	Norfolk	Virginia
United States	Peripheral Vascular Associates	San Antonio	Texas
United States	Stonybrook University Medical Center	Stony Brook	New York
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Number of Patients Surviving at One Month		One month	Yes
Secondary	Number of Patients Surviving at 6 Months		6 months	Yes
Secondary	Number of Patients Surviving at 12 Months		12 months	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No