Drug-coated Balloon CatheterEQUATEURNCT04798352
Follow-up Study in French Practice to Evaluate Improvements in Walking and Pain Relief in Patients Treated With Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon
A study testing 6-minute walk test, WIQ functional questionnaire and quality of life questionnaires (EQ5D5L and SF-36) in people with Drug-coated Balloon Catheter, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This study is part of the subordination for the renewal of the registration of the LUTONIXR035 or RANGERTM drug coated balloon catheter by the CNEDiMTS following the transmission of the results of a French study on quality of life (evaluation of pain relief and walking evaluation criteria) for patients treated for de… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug-coated Balloon Catheter
- What is being tested?
- 6-minute walk test, WIQ functional questionnaire and quality of life questionnaires (EQ5D5L and SF-36)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2020to 8 Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient having given express oral consent
- patient to be treated by endovascular procedure with a LUTONIXR035 or RANGER TM drug coated balloon catheter according to the recommendations of the ANSM dated 13/05/2019 1 and possible updates of these recommendations.
Who cannot join
- pregnant or likely to be pregnant (a pregnancy test may be carried out if necessary according to the centre's practice)
- adult unable to express consent
- patient whose follow-up is considered impossible by the investigator (comprehension problem, planned move, ...)
- Per-intervention exclusion criteria
- patient considered to have failed endovascular treatment (presence of residual stenosis of more than 30% after surgery despite the possible use of a stent.
- Patient operated on but for whom the balloon was not used during the procedure
- Patient operated but for whom another balloon than those under study was finally used during the operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up Study in French Practice to Evaluate the Improvement of Gait and Pain Relief in Patients Treated With Endovascular Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon
This study is part of the subordination for the renewal of the registration of the LUTONIXR035 or RANGERTM drug coated balloon catheter by the CNEDiMTS following the transmission of the results of a French study on quality of life (evaluation of pain relief and walking evaluation criteria) for patients treated for de novo lesions of the femoropopliteal artery above the knee by endovascular treatment with LUTONIXR035 or RANGERTM drug-coated balloon catheters.
In accordance with the HAS practical guide on the approval of medical devices in France (November 2017), the protocol for this study was submitted in advance to the HAS and its suggestions were taken into account when drafting the objectives relative to the population to be included.
A second exhaustive study will be conducted in parallel using SNDS data to complete the CNEDiMTS application in order to evaluate, in the context of this registration renewal, the interest of the technique by documenting limb preservation, overall survival, the rate of re-interventions and the number of stents implanted.
- Conditions
- Drug-coated Balloon Catheter
- Being tested
- 6-minute walk test, WIQ functional questionnaire, quality of life questionnaires (EQ5D5L and SF-36)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk testOther
6-minute walk test
WIQ functional questionnaireOther
WIQ functional questionnaire
quality of life questionnaires (EQ5D5L and SF-36)Other
quality of life questionnaires (EQ5D5L and SF-36)
| Study group | Role | What they receive |
|---|---|---|
| LUTONIX(R)035 drug-coated balloon catheter | Experimental | Not described Receives: Other: 6-minute walk test; Other: WIQ functional questionnaire; Other: quality of life questionnaires (EQ5D5L and SF-36) |
| RANGER TM drug-coated balloon catheter | Experimental | Not described Receives: Other: 6-minute walk test; Other: WIQ functional questionnaire; Other: quality of life questionnaires (EQ5D5L and SF-36) |
What is being measured
The primary outcome is the main question the study is designed to answer.
average score of the WIQ specific self-questionnaire
Measured: at inclusion
average score of the WIQ specific self-questionnaire
progression of the functional limitations for walking evaluated by the average score of the WIQ specific self-questionnaire 12 months after surgery
Measured: and at 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start4 Dec 2020
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-coated Balloon CatheterStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798352
- Sponsor's protocol ID
- STEINMETZ BOSTON BARD 2019
- Acronym
- EQUATEUR
- Status last verified
- Feb 2026
- First submitted
- 8 Mar 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study in French Practice to Evaluate the Improvement of Gait and Pain Relief in Patients Treated With Endovascular Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon
- ClinicalTrials.gov ID
- NCT04798352
- Acronym / sponsor ID
- EQUATEUR / STEINMETZ BOSTON BARD 2019
- Conditions
- Drug-coated Balloon Catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 15 Mar 2021 (actual)
- 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 study is part of the subordination for the renewal of the registration of the LUTONIXR035 or RANGERTM drug coated balloon catheter by the CNEDiMTS following the transmission of the results of a French study on quality of life (evaluation of pain relief and walking evaluation criteria) for patients treated for de novo lesions of the femoropopliteal artery above the knee by endovascular treatment with LUTONIXR035 or RANGERTM drug-coated balloon catheters.
In accordance with the HAS practical guide on the approval of medical devices in France (November 2017), the protocol for this study was submitted in advance to the HAS and its suggestions were taken into account when drafting the objectives relative to the population to be included.
A second exhaustive study will be conducted in parallel using SNDS data to complete the CNEDiMTS application in order to evaluate, in the context of this registration renewal, the interest of the technique by documenting limb preservation, overall survival, the rate of re-interventions and the number of stents implanted.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUTONIX(R)035 drug-coated balloon catheter | Experimental | Other: 6-minute walk test, Other: WIQ functional questionnaire, Other: quality of life questionnaires (EQ5D5L and SF-36) |
| RANGER TM drug-coated balloon catheter | Experimental | Other: 6-minute walk test, Other: WIQ functional questionnaire, Other: quality of life questionnaires (EQ5D5L and SF-36) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patient having given express oral consent
- patient to be treated by endovascular procedure with a LUTONIXR035 or RANGER TM drug coated balloon catheter according to the recommendations of the ANSM dated 13/05/2019 1 and possible updates of these recommendations.
Key exclusion criteria (7 listed)
- pregnant or likely to be pregnant (a pregnancy test may be carried out if necessary according to the centre's practice)
- adult unable to express consent
- patient whose follow-up is considered impossible by the investigator (comprehension problem, planned move, ...)
- Per-intervention exclusion criteria
- patient considered to have failed endovascular treatment (presence of residual stenosis of more than 30% after surgery despite the possible use of a stent.
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-minute walk test6-minute walk test | Other | LUTONIX(R)035 drug-coated balloon catheter, RANGER TM drug-coated balloon catheter |
| WIQ functional questionnaireWIQ functional questionnaire | Other | LUTONIX(R)035 drug-coated balloon catheter, RANGER TM drug-coated balloon catheter |
| quality of life questionnaires (EQ5D5L and SF-36)quality of life questionnaires (EQ5D5L and SF-36) | Other | LUTONIX(R)035 drug-coated balloon catheter, RANGER TM drug-coated balloon catheter |
Primary outcome
average score of the WIQ specific self-questionnaire
Time frame: at inclusion
average score of the WIQ specific self-questionnaire
Time frame: and at 12 months after surgery
progression of the functional limitations for walking evaluated by the average score of the WIQ specific self-questionnaire 12 months after surgery
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 12 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-minute walk test, WIQ functional questionnaire and quality of life questionnaires (EQ5D5L and SF-36) in people with Drug-coated Balloon Catheter, run by Centre Hospitalier Universitaire Dijon 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 7 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 12 Feb 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?
average score of the WIQ specific self-questionnaire (time frame: at inclusion). 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 Feb 2026.