Superficial Femoral Artery StenosisTOCAFNCT04434586
Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
A study testing femoropopliteal revascularization for TASC C or TASC D lesion in people with Superficial Femoral Artery Stenosis and Claudication, run by University Hospital, Lille at 1 site in France.
Trial summary
This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Femoral Artery Stenosis, Claudication, Ischemic Leg
- What is being tested?
- femoropopliteal revascularization for TASC C or TASC D lesion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2020to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient over 18 years old
- Femoral-popliteal lesion TASC-C or TASC-D de novo (F1 to P1)
- Starting lesion on the superficial femoral artery and not extending beyond the intercondylar notch (P2)
- ≥1 continuous permeable leg axis directly injecting the plantar arch
- Rutherford 2-5
Who cannot join
- Patient under personal protection regime (tutorship, guardianship)
- Absence of arterial axis in permeable leg
- Patient presenting a limb acute ischaemia (chart evolving since less than 14 days)
- Patient without favorable element to consider healing
- History of stents on the femoropopliteal axis
- History of femoropopliteal bypass
- Untreated stenosis ≥30% on the iliac axis and common femoral upstream
- Popliteal lesion beyond the intercondylar notch (P2)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Insitut Coeur-Poumon, CHU
Lille, 59037
0320445962
Jonathan SOBOCINSKI, MD
About this study
This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.
- Being tested
- femoropopliteal revascularization for TASC C or TASC D lesion
- Keywords
- femoral recanalization, optical coherence tomography (OCT), endovascular treatment, TASC-C,, TASC-D
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoropopliteal revascularization for TASC C or TASC D lesionDevice
Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control
| Study group | Role | What they receive |
|---|---|---|
| angiography 2D | Sham comparator | Control group: an arteriography will be performed on the entire treated segment to assess the quality of the result, the application or not an active balloon will be left to the discretion of the operator. In case of application of the active balloon, a new arteriography before decision or not the use of stenting will be practiced. In case of stenting, an arteriographic final is performed. Receives: Device: femoropopliteal revascularization for TASC C or TASC D lesion |
| angiography 2D with OCT | Experimental | Experimental group: an arteriography and OCT acquisition on the entire treated segment to ensure the quality of the result, the application or not of an active ball will be left. In case of application of the active balloon, a new arteriography and OCT acquisition before decision or not the use of stenting will be practiced. In case of stenting, a final arteriography and then OCT acquisition are performed. Receives: Device: femoropopliteal revascularization for TASC C or TASC D lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate at 1 year.
The permeability rate is defined by the echodoppler criteria: PVS>2.4m/s or appearance of stenosis on the previously treated segment >70%.
Measured: at 12 months (+/- 2months)
Secondary outcomes (4)
Primary patency rate at 1 year.
Measured: at 1month (+/- 10days), 6months (+/- 1month)
Target lesion revascularisation
corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability
Measured: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Target vessel revascularisation
corresponds to the occurrence of a re-intervention on the previously treated artery, whatever the level, in order to maintain its permeability.
Measured: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
cost-effectiveness analyses
Cost-effectiveness analysis between 2 therapeutic strategies: The costs related to each strategy are calculated taking into account the direct and indirect costs.
Measured: at 12 months (+/- 2months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start16 Jun 2020
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
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 Superficial Femoral Artery StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Jonathan Sobocinski, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434586
- Sponsor's protocol ID
- 2018_88
- Other IDs
- 2019-A01055-52
- Acronym
- TOCAF
- Status last verified
- Dec 2025
- First submitted
- 8 Jun 2020
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dubosq M, Goueffic Y, Duhamel A, Denies F, Dervaux B, Goyault G, Sobocinski J. Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial. Ann Vasc Surg. 2021 Jan;70:362-369. doi: 10.1016/j.avsg.2020.06.061. Epub 2020 Jul 4.
PubMed 32634565
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
- ClinicalTrials.gov ID
- NCT04434586
- Acronym / sponsor ID
- TOCAF / 2018_88
- Keywords
- femoral recanalization, optical coherence tomography (OCT), endovascular treatment, TASC-C,, TASC-D
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 17 Jun 2020 (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 is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| angiography 2D | Sham comparator | Device: femoropopliteal revascularization for TASC C or TASC D lesionControl group: an arteriography will be performed on the entire treated segment to assess the quality of the result, the application or not an active balloon will be left to the discretion of the operator. In case of application of the active balloon, a new arteriography before decision or not the use of stenting will be practiced. In case of stenting, an arteriographic final is performed. |
| angiography 2D with OCT | Experimental | Device: femoropopliteal revascularization for TASC C or TASC D lesionExperimental group: an arteriography and OCT acquisition on the entire treated segment to ensure the quality of the result, the application or not of an active ball will be left. In case of application of the active balloon, a new arteriography and OCT acquisition before decision or not the use of stenting will be practiced. In case of stenting, a final arteriography and then OCT acquisition are performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient over 18 years old
- Femoral-popliteal lesion TASC-C or TASC-D de novo (F1 to P1)
- Starting lesion on the superficial femoral artery and not extending beyond the intercondylar notch (P2)
- ≥1 continuous permeable leg axis directly injecting the plantar arch
- Rutherford 2-5
Key exclusion criteria (8 listed)
- Patient under personal protection regime (tutorship, guardianship)
- Absence of arterial axis in permeable leg
- Patient presenting a limb acute ischaemia (chart evolving since less than 14 days)
- Patient without favorable element to consider healing
- History of stents on the femoropopliteal axis
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 revascularization for TASC C or TASC D lesionFemoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control | Device | angiography 2D, angiography 2D with OCT |
Primary outcome
Primary patency rate at 1 year.
Time frame: at 12 months (+/- 2months)
The permeability rate is defined by the echodoppler criteria: PVS>2.4m/s or appearance of stenosis on the previously treated segment >70%.
4 secondary outcomes
Primary patency rate at 1 year.
Time frame: at 1month (+/- 10days), 6months (+/- 1month)
Target lesion revascularisation
Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Target vessel revascularisation
Time frame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
cost-effectiveness analyses
Time frame: at 12 months (+/- 2months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Results publication: PubMed 32634565Dubosq M, Goueffic Y, Duhamel A, Denies F, Dervaux B, Goyault G, Sobocinski J. Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial. Ann Vasc Surg. 2021 Jan;70:362-369. doi: 10.1016/j.avsg.2020.06.061. Epub 2020 Jul 4.
Related trials for Superficial Femoral Artery Stenosis
Active, not recruiting
SELUTION4SFA Trial
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Active, not recruiting
First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease
Superficial Femoral Artery Stenosis, Popliteal Artery Stenosis
Not yet recruitingPhase 2/3
A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries.
Popliteal Artery Disease, Superficial Femoral Artery Disease
Active, not recruitingObservational study
SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
Peripheral Arterial Disease, Superficial Femoral Artery Stenosis
Not yet recruitingObservational study
Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease
Superficial Femoral Artery Stenosis, Iliac Artery Stenosis
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.
Jonathan Sobocinski, MD,PhD principal investigator
University Hospital, Lille
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 revascularization for TASC C or TASC D lesion in people with Superficial Femoral Artery Stenosis and Claudication, run by University Hospital, Lille 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Sobocinski, MD,PhD (0320445911, jonathan.sobocinski@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate at 1 year. (time frame: at 12 months (+/- 2months)). 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 NCT04434586, 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 23 Dec 2025.