Intermittent ClaudicationPhase 4NCT00300690
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)
A Phase 4 study testing 6 mm Uni-graft® (B-Braun) and 6 mm Gore-Tex® (WL Gore) in people with Intermittent Claudication and Critical Limb Ischemia, run by University Hospital, Gentofte, Copenhagen.
Trial summary
This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication, Critical Limb Ischemia
- What is being tested?
- 6 mm Uni-graft® (B-Braun) and 6 mm Gore-Tex® (WL Gore)
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Oct 1993to Jan 1999
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who require revascularisation of the lower extremity suitable for above-knee femoro-popliteal bypass surgery.
Who cannot join
- pregnancy
- No consent to participate in the study
- Previous enrollment in the study
- follow-up is not possible
About this study
Official title: Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft. Multicenter Randomized Study of an Impregnated Knitted Polyester Prosthesis Vs. PTFE (Uni-Graft Vs Gore-Tex).
This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.
Read the detailed description
Objective: To investigate whether patency rates of 6 mm gelatine coated, knitted, double velour polyester prostheses are equal to the 6 mm thinwalled ePTFE prostheses as above-knee femoro-popliteal bypass graft
- Conditions
- Intermittent Claudication, Critical Limb Ischemia
- Being tested
- 6 mm Uni-graft® (B-Braun), 6 mm Gore-Tex® (WL Gore)
- Keywords
- Lower extremity bypass surgery, femoro-popliteal bypass, Dacron material, PTFE material
- Medical subject headings
- Intermittent Claudication, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 mm Uni-graft® (B-Braun)Device
6 mm Gore-Tex® (WL Gore)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary uncorrected graft patency after 2 years
Secondary outcomes (3)
- Secondary graft patency after two years
- Limb survival after two years
- Complication rate perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startOct 1993
- Study completionJan 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- 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
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Investigators
- Torben V Schroeder, Professor, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300690
- Sponsor's protocol ID
- C124
- Status last verified
- Mar 2006
- First submitted
- 8 Mar 2006
- Last updated
- 9 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft. Multicenter Randomized Study of an Impregnated Knitted Polyester Prosthesis Vs. PTFE (Uni-Graft Vs Gore-Tex).
- ClinicalTrials.gov ID
- NCT00300690
- Acronym / sponsor ID
- C124
- Conditions
- Intermittent Claudication, Critical Limb Ischemia
- Keywords
- Lower extremity bypass surgery, femoro-popliteal bypass, Dacron material, PTFE material
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Study start
- Oct 1993
- Study completion
- Jan 1999
- First posted
- 9 Mar 2006 (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.
This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.
Detailed description
Objective: To investigate whether patency rates of 6 mm gelatine coated, knitted, double velour polyester prostheses are equal to the 6 mm thinwalled ePTFE prostheses as above-knee femoro-popliteal bypass graft
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who require revascularisation of the lower extremity suitable for above-knee femoro-popliteal bypass surgery.
Key exclusion criteria (4 listed)
- pregnancy
- No consent to participate in the study
- Previous enrollment in the study
- follow-up is not possible
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 |
|---|---|---|
| 6 mm Uni-graft® (B-Braun) | Device | – |
| 6 mm Gore-Tex® (WL Gore) | Device | – |
Primary outcome
Primary uncorrected graft patency after 2 years
3 secondary outcomes
- Secondary graft patency after two years
- Limb survival after two years
- Complication rate perioperatively
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 9 Mar 2006.
Related trials for Intermittent Claudication
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Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
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.
Torben V Schroeder, Professor principal investigator
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 6 mm Uni-graft® (B-Braun) and 6 mm Gore-Tex® (WL Gore) in people with Intermittent Claudication and Critical Limb Ischemia, run by University Hospital, Gentofte, Copenhagen.
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 1 inclusion and 4 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 9 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
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 uncorrected graft patency after 2 years. 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 9 Mar 2006.