Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
femoropopliteal revascularization for TASC C or TASC D lesion
DeviceFemoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control
Treatment groups
166 Participants
are divided into 2 treatment groupsGroup A: angiography 2DSham comparator 1 intervention
Group B: angiography 2D with OCTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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%.
Time frame
at 12 months (+/- 2months)Secondary outcomes
1
Primary patency rate at 1 year.
Time frame
at 1month (+/- 10days), 6months (+/- 1month)2
Target lesion revascularisation
corresponds to the occurrence of a re-intervention on the treated segment to maintain or restore permeability
Time frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)3
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.
Time frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)4
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.
Time frame
at 12 months (+/- 2months)Other outcomes
1
Rutherford scale considered ordinal variable
Rutherford grade of 2-4 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).
Time frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)2
Variation in Ankle Brachial Index between randomization and 1, 6, 12 months on the revascularized limb in the study.
Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm
Time frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)3
Variation in quality of life assessed by Walk Impairment Questionnary between randomization and 1, 6, 12 months.
a questionnaire for evaluating walking impairment in patients Parameters: * difficulty walking a distance during the past month * difficulty walking at a certain speed during the past month * symptoms associated with walking impairment
Time frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)4
Variation in quality of life assessed by EQ5D scores between randomization and 1, 6, 12 months.
overall score on a numeric scale "check the box that best describes your health today", 5 themes (mobility, autonomy of the person, common activities, pain / discomfort, anxiety / depression)
Time frame
at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Abbott
Collaborator
Source ClinicalTrials.gov