ArteritisREVANCT00221715
Comparison of Two Lower Limb Bypass Types : Prosthesis Versus Autologous Vein
A study testing femoropopliteal artery bypass in people with Arteritis and Diabetes, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. This bypass can be performed either with DACRON or PTFE prosthesis or with the autologous saphenous vein. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- femoropopliteal artery bypass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2002to May 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lower limbs arteritis : II to IV arteritis level, above knee femoro popliteal bypass indication
- signed informed consent
Who cannot join
- no contra indication to the use of prosthesis
- Available saphenous vein
- no major trophic trouble
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Study Comparing Prosthesis and Autologous Vein for Revascularisation With Above Knee Femoropopliteal Bypass.
When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. This bypass can be performed either with DACRON or PTFE prosthesis or with the autologous saphenous vein. Both technics are used but they have not been compared regarding bypass permeability and limb salvage. Thus, this study will compare the permeability rate of above knee femoro popliteal surgery whether performed with autologous vein versus prosthesis
Read the detailed description
When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. This bypass can be performed with either DACRON or PTFE prosthesis or with the autologous saphenous vein. The principle disadvantages of prosthesis are their prejudged worse permeability and the risk of infection. Too few reliable randomised, multicentric studies in this indication comparing vein bypasses versus prosthesis bypasses have been conducted to firmly confirm the first argument. Thus, the purpose of this multicentric, randomised, national study is to compare, 5 years after surgery, the permeability rate of above knee femoropopliteal bypass with vein versus prosthesis. Primary and secondary permeability, permeability predictive factors, and leg salvage rate will also be assessed. One hundred enrolled patients with II to IV level leg arteritis will randomly be assigned to one of the surgery groups : vein or prosthesis (50 each). The recruiting period will last 3 years and a half, and the follow up 5 years for each patient. The main primary outcome, bypass permeability, will be assessed through Doppler ultrasonography during five years. Secondary endpoints, mortality and morbidity, will be evaluated during the clinical follow up. Permeability predictive factors, primary and secondary permeability, leg salvage will also be recorded. If the permeability rates are equivalent between prosthesis and vein, the use of prosthesis will be preferred as this surgery is easier and faster, and as it is important that the vein remains available for distal revascularisation (where it is more efficient) and for revascularisation of coronary arteries
- Being tested
- femoropopliteal artery bypass
- Keywords
- arteritis, lower limb ischemia, femoropopliteal artery bypass, blood vessel prothesis implantation, saphenous vein, vascular permeability, doppler ultrasonography, randomized clinical trials, efficacy study
- Medical subject headings
- Arteritis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoropopliteal artery bypassDevice
Bypass by autologous saphenous vein
femoropopliteal artery bypassDevice
bypass by dacron or PTFE Prosthesis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | bypass by autologous saphenous vein Receives: Device: femoropopliteal artery bypass |
| 2 | Active comparator | bypass by dacron or PTFE Prosthesis Receives: Device: femoropopliteal artery bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography
Measured: 5 years
Secondary outcomes (5)
Mortality
Measured: 5 years
Morbidity
Measured: 5 years
permeability predictive factors (smoking habits, diabetes, hyperlipidemia, bypass diameter)
Measured: 5 years
Primary and secondary permeability
Measured: 5 years
leg salvage
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArteritisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Dominique Midy, Professor, Principal investigator, University Hospital, BordeauxGeneviève Chêne, Professor, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221715
- Sponsor's protocol ID
- 9248-01
- Other IDs
- 2002/03/007, CHUBX 2001/06
- Acronym
- REVA
- Status last verified
- May 2013
- First submitted
- 13 Sep 2005
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Midy D, Papon X, Patra P, Hassen Kodja R, Feugier P, Plissonnier D, Reix T, Chene G, Berard X; Association Universitaire de Recherche en Chirurgie Vasculaire (AURC); Association Universitaire de Recherche en Chirurgie Vasculaire AURC. Randomized Study of Noninferiority Comparing Prosthetic and Autologous Vein Above-Knee Femoropopliteal Bypasses. Ann Vasc Surg. 2016 Feb;31:99-104. doi: 10.1016/j.avsg.2015.07.047. Epub 2015 Nov 26.
PubMed 26631773
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study Comparing Prosthesis and Autologous Vein for Revascularisation With Above Knee Femoropopliteal Bypass.
- ClinicalTrials.gov ID
- NCT00221715
- Acronym / sponsor ID
- REVA / 9248-01
- Keywords
- arteritis, lower limb ischemia, femoropopliteal artery bypass, blood vessel prothesis implantation, saphenous vein, vascular permeability, doppler ultrasonography, randomized clinical trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jul 2002
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 22 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.
When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. This bypass can be performed either with DACRON or PTFE prosthesis or with the autologous saphenous vein. Both technics are used but they have not been compared regarding bypass permeability and limb salvage. Thus, this study will compare the permeability rate of above knee femoro popliteal surgery whether performed with autologous vein versus prosthesis
Detailed description
When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. This bypass can be performed with either DACRON or PTFE prosthesis or with the autologous saphenous vein. The principle disadvantages of prosthesis are their prejudged worse permeability and the risk of infection. Too few reliable randomised, multicentric studies in this indication comparing vein bypasses versus prosthesis bypasses have been conducted to firmly confirm the first argument. Thus, the purpose of this multicentric, randomised, national study is to compare, 5 years after surgery, the permeability rate of above knee femoropopliteal bypass with vein versus prosthesis. Primary and secondary permeability, permeability predictive factors, and leg salvage rate will also be assessed. One hundred enrolled patients with II to IV level leg arteritis will randomly be assigned to one of the surgery groups : vein or prosthesis (50 each). The recruiting period will last 3 years and a half, and the follow up 5 years for each patient. The main primary outcome, bypass permeability, will be assessed through Doppler ultrasonography during five years. Secondary endpoints, mortality and morbidity, will be evaluated during the clinical follow up. Permeability predictive factors, primary and secondary permeability, leg salvage will also be recorded. If the permeability rates are equivalent between prosthesis and vein, the use of prosthesis will be preferred as this surgery is easier and faster, and as it is important that the vein remains available for distal revascularisation (where it is more efficient) and for revascularisation of coronary arteries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: femoropopliteal artery bypassbypass by autologous saphenous vein |
| 2 | Active comparator | Device: femoropopliteal artery bypassbypass by dacron or PTFE Prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- lower limbs arteritis : II to IV arteritis level, above knee femoro popliteal bypass indication
- signed informed consent
Key exclusion criteria (3 listed)
- no contra indication to the use of prosthesis
- Available saphenous vein
- no major trophic trouble
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 |
|---|---|---|
| femoropopliteal artery bypassBypass by autologous saphenous vein | Device | 1 |
| femoropopliteal artery bypassbypass by dacron or PTFE Prosthesis | Device | 2 |
Primary outcome
Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography
Time frame: 5 years
5 secondary outcomes
Mortality
Time frame: 5 years
Morbidity
Time frame: 5 years
permeability predictive factors (smoking habits, diabetes, hyperlipidemia, bypass diameter)
Time frame: 5 years
Primary and secondary permeability
Time frame: 5 years
leg salvage
Time frame: 5 years
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 10 Jun 2026.
- Results publication: PubMed 26631773Midy D, Papon X, Patra P, Hassen Kodja R, Feugier P, Plissonnier D, Reix T, Chene G, Berard X; Association Universitaire de Recherche en Chirurgie Vasculaire (AURC); Association Universitaire de Recherche en Chirurgie Vasculaire AURC. Randomized Study of Noninferiority Comparing Prosthetic and Autologous Vein Above-Knee Femoropopliteal Bypasses. Ann Vasc Surg. 2016 Feb;31:99-104. doi: 10.1016/j.avsg.2015.07.047. Epub 2015 Nov 26.
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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.
Dominique Midy, Professor principal investigator
University Hospital, Bordeaux
Geneviève Chêne, Professor study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing femoropopliteal artery bypass in people with Arteritis and Diabetes, run by University Hospital, Bordeaux at 1 site in France.
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 2 inclusion and 3 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221715, which also lists 1 linked publication.
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 10 Jun 2026.