Peripheral Vascular DiseasesNCT00205790
GORE-TEX PROPATEN Vascular Graft Study
A study testing Vascular graft in people with Peripheral Vascular Diseases, run by W.L.Gore & Associates at 18 sites in United States.
Trial summary
To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Vascular graft
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 18 sitesUnited States
- Study dates
- Feb 2003to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 primary above-knee bypass where the proximal anastomosis will be to the common femoral or proximal superficial femoral artery and the distal anastomosis will be the popliteal artery proximal to the medial head of the gastrocnemius;
- Patient has Grade III or IV occlusive vascular disease;
- Patient has a postoperative 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 month, 6 months and 12 months post procedure;
- Patient is willing and able to provide written, informed consent.
Who cannot join
- Patient had a previous bypass in the diseased extremity (below iliacs);
- Patient has known coagulation disorders including hypercoagulability;
- Patient has had any previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin;
- Patient has an acute embolic arterial occlusion;
- Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
- Patient had percutaneous transluminal angioplasty to the implant site within the previous 30 days;
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- Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure;
- Patient has active infection in the region of graft placement; or
- Patient has an incomplete preoperative assessment (as outlined in this protocol) due to an emergency procedure, a traumatic injury or any other reason.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Upper Chesapeake Medical Center
Baltimore, Maryland, 21014
William Beaumont Hospital
Bingham Farms, Michigan, 48025
Maimonides Hospital
Brooklyn, New York, 11219
Charleston Area Medical Center
Charleston, West Virginia, 25304
Ohio State University Medical Center
Columbus, Ohio, 43210
Memorial Regional Hospital
Hollywood, Florida, 33028
University of Mississippi Medical Center
Jackson, Mississippi, 39216
St. Vincent's Hospital
Jacksonville, Florida, 32204
Borgess Hospital
Kalamazoo, Michigan, 49048
Jewish Hospital
Louisville, Kentucky, 40202
Medical Center of Central Georgia
Macon, Georgia, 31201
Baptist East Hospital
Memphis, Tennessee, 38120
Morristown Memorial Hospital
Morristown, New Jersey, 07960
Sacred Heart Hospital
Pensacola, Florida, 32504
Wilkes-Barre General Hospital
Plains, Pennsylvania, 18705
Baystate Medical Center
Springfield, Massachusetts, 01107
Mercy Medical Center
Springfield, Massachusetts, 01107
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts
To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Vascular graft
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular graftDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency at 12 months
Major device complication rates at 12 months
Secondary outcomes (2)
Technical failures
Secondary patency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Enrico Ascher, MD, Principal investigator, Maimonides Hospital, Brooklyn NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205790
- Sponsor's protocol ID
- PPT-01-04
- Status last verified
- Aug 2008
- First submitted
- 12 Sep 2005
- Last updated
- 7 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts
- ClinicalTrials.gov ID
- NCT00205790
- Acronym / sponsor ID
- PPT-01-04
- Conditions
- Peripheral Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Study completion
- Aug 2007 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
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 primary above-knee bypass where the proximal anastomosis will be to the common femoral or proximal superficial femoral artery and the distal anastomosis will be the popliteal artery proximal to the medial head of the gastrocnemius;
- Patient has Grade III or IV occlusive vascular disease;
- Patient has a postoperative 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 month, 6 months and 12 months post procedure;
Key exclusion criteria (9 listed)
- Patient had a previous bypass in the diseased extremity (below iliacs);
- Patient has known coagulation disorders including hypercoagulability;
- Patient has had any previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin;
- Patient has an acute embolic arterial occlusion;
- Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
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 |
|---|---|---|
| Vascular graft | Device | – |
Primary outcome
Primary patency at 12 months
Major device complication rates at 12 months
2 secondary outcomes
Technical failures
Secondary patency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2008.
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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.
Enrico Ascher, MD principal investigator
Maimonides Hospital, Brooklyn NY
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular graft in people with Peripheral Vascular Diseases, run by W.L.Gore & Associates at 18 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 9 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: finished, as of the sponsor's last update on 7 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary patency at 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 7 Aug 2008.