Clinical trial NCT04434586: Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
Official title: Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Superficial Femoral Artery Stenosis
Claudication
Ischemic Leg
Keywords: femoral recanalization
optical coherence tomography (OCT)
endovascular treatment
TASC-C,
TASC-D
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2020-06-17
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Primary patency rate at 1 year.
timeFrame: at 12 months (+/- 2months)
Secondary outcomes:
measure: Primary patency rate at 1 year.
timeFrame: at 1month (+/- 10days), 6months (+/- 1month)
measure: Target lesion revascularisation
timeFrame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
measure: Target vessel revascularisation
timeFrame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
measure: cost-effectiveness analyses
timeFrame: at 12 months (+/- 2months)
Other outcomes:
measure: Rutherford scale considered ordinal variable
timeFrame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
measure: Variation in Ankle Brachial Index between randomization and 1, 6, 12 months on the revascularized limb in the study.
timeFrame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
measure: Variation in quality of life assessed by Walk Impairment Questionnary between randomization and 1, 6, 12 months.
timeFrame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
measure: Variation in quality of life assessed by EQ5D scores between randomization and 1, 6, 12 months.
timeFrame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
measure: Limb Rescue Rate
timeFrame: at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)
Locations:
city: Lille
country: France
facility: Insitut Coeur-Poumon, CHU
Study officials:
affiliation: University Hospital, Lille
name: Jonathan Sobocinski, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.