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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A01055-52 | Other Identifier | ID-RCB number,ANSM |
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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| femoropopliteal revascularization for TASC C or TASC D lesion | Device | Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | at 12 months (+/- 2months) |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency rate at 1 year. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Sobocinski, MD,PhD | Contact | 0320445911 | jonathan.sobocinski@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Sobocinski, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insitut Coeur-Poumon, CHU | Recruiting | Lille | 59037 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32634565 | Result | 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. |
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| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. | 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. | at 12 months (+/- 2months) |
| 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 |
| at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) |
| 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:
| at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) |
| 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) | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) |
| Limb Rescue Rate | at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months) |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |