Peripheral Arterial Occlusive DiseasePhase 4PRODIGYNCT00617279
GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft
A Phase 4 study testing GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft in people with Peripheral Arterial Occlusive Disease, run by W.L.Gore & Associates at 17 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2007to Feb 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease.
- Patient meets the disadvantaged autologous vein criteria described in Section 4.1.
- Patient has a post-operative life expectancy greater than one year.
- Patient is at least 21 years of age.
- 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.
- Patient is willing and able to provide written, informed consent.
Who cannot join
- Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin.
- Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease.
- Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts.
- 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.
- Patient has been previously randomized for this study.
- Patient has active infection in the region of graft placement.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Albany Medical Center
Albany, New York, 12208
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Maryland Medical Center
Baltimore, Maryland, 21201
Vascular Specialty Associates
Baton Rouge, Louisiana, 70809
University Of Alabama Medical Center
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Greenville Hospital System
Greenville, South Carolina, 29605
The Methodist Hospital System
Houston, Texas, 77030
University of Tennessee medical Center
Knoxville, Tennessee, 37920
Medical Center of Central Georgia
Macon, Georgia, 31201
Sentara Norfolk Hospital
Norfolk, Virginia, 23507
Peripheral Vascular Associates
San Antonio, Texas, 78205
Stonybrook University Medical Center
Stony Brook, New York, 11794
Montifiore Medical Center
The Bronx, New York, 10467
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft For Below-Knee Arterial Bypass (PRODIGY Study)
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.
Read the 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.
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- GORE PROPATEN Vascular Graft, Disadvantaged Autologous Vein Graft
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE PROPATEN Vascular GraftDevice
Arterial Occlusion Bypass
Disadvantaged Autologous Vein GraftProcedure or surgery
Arterial Occlusion Bypass
| Study group | Role | What they receive |
|---|---|---|
| GORE PROPATEN Vascular Graft: | Active comparator | Not described Receives: Device: GORE PROPATEN Vascular Graft |
| Disadvantaged Autologous Vein Graft | Active comparator | Not described Receives: Procedure: Disadvantaged Autologous Vein Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one month post-index procedure
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One month
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.
Measured: 6 months
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Number of Patients Surviving at One Month
Measured: One month
Number of Patients Surviving at 6 Months
Measured: 6 months
Number of Patients Surviving at 12 Months
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Study terminated due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard F. Neville, MD, Principal investigator, Georgetown University HospitalJennifer Recknor, Ph.D., Study director, W.L.Gore & Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617279
- Sponsor's protocol ID
- PPT 07-05
- Acronym
- PRODIGY
- Status last verified
- Dec 2011
- First submitted
- 18 Dec 2007
- Last updated
- 12 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft For Below-Knee Arterial Bypass (PRODIGY Study)
- ClinicalTrials.gov ID
- NCT00617279
- Acronym / sponsor ID
- PRODIGY / PPT 07-05
- Conditions
- Peripheral Arterial Occlusive Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to low enrollment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Posted 12 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GORE PROPATEN Vascular Graft: | Active comparator | Device: GORE PROPATEN Vascular Graft |
| Disadvantaged Autologous Vein Graft | Active comparator | Procedure: Disadvantaged Autologous Vein Graft |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease.
- Patient meets the disadvantaged autologous vein criteria described in Section 4.1.
- Patient has a post-operative life expectancy greater than one year.
- Patient is at least 21 years of age.
- 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.
Key exclusion criteria (6 listed)
- Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin.
- Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease.
- Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts.
- 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.
- Patient has been previously randomized for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GORE PROPATEN Vascular GraftArterial Occlusion Bypass | Device | GORE PROPATEN Vascular Graft: |
| Disadvantaged Autologous Vein GraftArterial Occlusion Bypass | Procedure or surgery | Disadvantaged Autologous Vein Graft |
Primary outcome
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.
23 secondary outcomes
Number of Patients With Primary Patency at One Month Post-procedure
Time frame: One month
Number of Patients With Primary Patency at 6 Months Post-procedure
Time frame: 6 months
Number of Patients With Assisted Primary Patency at One Month Post-procedure
Time frame: One month
Number of Patients With Assisted Primary Patency at 6 Months Post-procedure
Time frame: 6 months
Number of Patients With Assisted Primary Patency at 12 Months Post-procedure
Time frame: 12 months
Number of Patients With Secondary Patency at One Month
Time frame: One month
Number of Patients With Secondary Patency at 6 Months
Time frame: 6 months
Number of Patients With Secondary Patency at 12 Months
Time frame: 12 months
Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure
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
Time frame: 6 months
Patients Experiencing Major Adverse Events Through 12 Months Post-procedure
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
Time frame: One month
Number of Patients With Wound/Graft Infection Through 6 Months
Time frame: 6 months
Number of Patients With Wound/Graft Infection Through 12 Months
Time frame: 12 months
Number of Patients With Delayed Wound Healing Through One Month Post-procedure
Time frame: One month
Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure
Time frame: 6 months
Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure
Time frame: 12 months
Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure
Time frame: One month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Peripheral Arterial Occlusive Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard F. Neville, MD principal investigator
Georgetown University Hospital
Jennifer Recknor, Ph.D. study director
W.L.Gore & Associates
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft in people with Peripheral Arterial Occlusive Disease, run by W.L.Gore & Associates at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Primary Patency at 12 Months Post-procedure (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.