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In lower limb peripheral arterial disease, the stage of intermittent claudication has a prevalence of more than 5% over the age of 60, and affects patients who are often still active. Frequent anatomical lesions are strictures / occlusions of the superficial femoral artery.
There is a current low level of evidence for the treatment modalities of long lesions (15-25 cm) of the superficial femoral artery and in particular no clinical trial comparing the femoro-popliteal bypass to the endovascular procedure whose patency in retrospective series. appears lower than that of surgery but nevertheless appears in the European recommendations for first-line treatment, with the absence of a dedicated trial being highlighted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bypass group | Experimental | Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis). |
|
| Endovascular procedure group | Active Comparator | Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoro-popliteal bypass | Procedure | Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency rate at 2 year follow-up. | Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency rate at 1 year follow-up. | Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass | 1 year |
| Secondary patency rate at 1 and 2 years follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
Secondary exclusion criterion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph TOUMA, MD, PhD | Contact | + 33 6 30 03 10 93 | + 33 | joseph.touma@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Joseph TOUMA, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU - Hôpitaux de Bordeaux | Active, not recruiting | Bordeaux | 33 000 | France | ||
| Hôpital Ambroise Paré, APHP |
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| Endovascular procedure | Procedure | Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty. |
|
Secondary patency is defined as the patency after treatment of a (re)occlusion of the index lesion or bypass.
| 1 and 2 years |
| Clinical improvement according to the Rutherford classification (clinical stages of ischemia) at 1, 6, 12 and 24 months | Clinical improvement is considered as an improvement in the Rutherford stage, i.e. a downshift to Rutherford 0 or 1. | 1, 6, 12 and 24 months |
| Improvement of the walking perimeter at 1 and 2 years (<200m,> 200m, unlimited) | Improvement of the walking perimeter is related to Rutherford stage. It is assessed by questioning the patient about the ability to have an unlimited walking distance, or moderately limited (> 200m), or severely limited (<200m). | 1 and 2 years |
| The increase in the systolic pressure index at discharge from hospital, then at 1, 6, 12 and 24 months (<0.75,> 0.75) | The increase of the systolic pressure index (SPI) is obtained by comparing all post-operative measures to pre-operative values. | 1, 6, 12 and 24 months |
| The quality of life measured by the Vascu-Qol 6 to 2 years | The quality of life assessment is obtained by filling the Vascu-Qol questionnaire and comparing the score with the preoperative value. | 2 years |
| The treatment burden measured by the Treatment Burden Questionnaire at 6 months | The treatment burden is evaluated by comparing the Treatment Burden Questionnaire score at 6 months with the preoperative value. | 6 months |
| Number of participants with adverse events as assessed by hematoma, redo surgery or vascular infection at 2 years | Tolerance is assessed by looking for the following events during the two postoperative years: hematoma that necessitated hospital stay, vascular infection, or redo surgery because of vascular complication. | During 2 years |
| Active, not recruiting |
| Boulogne-Billancourt |
| 92 100 |
| France |
| Hôpital de la Cavale Blanche | Active, not recruiting | Brest | 29 200 | France |
| Centre hospitalier René Dubos | Active, not recruiting | Cergy-Pontoise | 95 300 | France |
| Hôpital Henri Mondor, APHP | Recruiting | Créteil | 94 010 | France |
|
| Hôpital François Mitterrand | Recruiting | Dijon | 21 000 | France |
|
| Hôpital Edouard Herriot | Active, not recruiting | Lyon | 69 003 | France |
| Hôpital de la Timone, APHP | Not yet recruiting | Marseille | 13 005 | France |
|
| CHU de Nice | Active, not recruiting | Nice | 06 001 | France |
| CHU Carémeau | Not yet recruiting | Nîmes | 30 029 | France |
|
| Hôpital Européen Georges Pompidou, APHP | Active, not recruiting | Paris | 75 015 | France |
| Hôpital Bichat - Claude Bernard, APHP | Active, not recruiting | Paris | 75 018 | France |
| Hôpital La Pitié-Salpêtrière, APHP | Not yet recruiting | Paris | 75013 | France |
|
| CHU de Poitiers | Recruiting | Poitiers | 86 000 | France |
|
| CHU de Rangueil | Active, not recruiting | Toulouse | 31 400 | France |
| Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu | Not yet recruiting | Vandœuvre-lès-Nancy | 54 511 | France |
|
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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