| Статус: | Recruiting |
| Фаза: | N/A |
| Начало: | 1 ноября 2021 г. |
| Окончание: | 1 января 2027 г. |
| Описание: | The SIBERIA study demonstrated a clear advantage of CGuard stent implantation over the existing classical stent when using a distal anti-embolic device. At the same time, there is no Level 1 evidence for a difference between the proximal and distal anti-embolic device for the CGuard stent. |
| смотреть на ClinicalTrials.gov |
| Статус: | Unknown status |
| Фаза: | N/A |
| Начало: | 1 ноября 2020 г. |
| Окончание: | 1 декабря 2023 г. |
| Описание: | A recent study, where the authors studied the effectiveness of stenting of prolonged lesions (>200 mm) of the femoral-popliteal segment with nitinol stents (TASC II, D), showed unsatisfactory primary patency rates (45%) within 2 years follow up (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Another possible solution to the problem of stent breakage in the femoral-popliteal position is fasciotomy in Gunter's canal with dissection of the lamina vasto-adductoria. According to a pilot randomized study (Karpenko et al, 2019), the primary patency at 24 months was 60% in the stenting group supplemented with fasciotomy in Gunter's canal, and 28.5% in the stenting group without fasciotomy. These facts prove the need for a comparative study on a cohort of patients using a biomimetic interwoven nitinol stent. This is a pilot prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two methods of treating prolonged atherosclerotic lesions (TASC II, type D) of the arteries of the femoropopliteal segment above the knee. |
| смотреть на ClinicalTrials.gov |
| Статус: | Unknown status |
| Фаза: | N/A |
| Начало: | 1 октября 2020 г. |
| Окончание: | 1 декабря 2023 г. |
| Описание: | Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006). At the same time, a recent study, where the authors studied the effectiveness of stenting of long lesions (200 mm or more) of the chronic occlusions of the femoropopliteal segments (TASC II, D), showed unsatisfactory results (primary patency 45%) of the stented segment within 2 years (Lin et al, 2015). One of the possible solutions to the problem of breakage of stents in the femoral-popliteal position is a modified method of their manufacture by braiding from nitinol wire. Some studies with intervowen nitinol stents did show their resistance to breakage in this position. Moreover, the primary patency was > 70%. (Werner et al, 2014). These data suggest a better primary patency rate within 2 years with a longer lesion length (>200 mm). This is a prospective, randomized, open-label study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment above the knee, TASC II type D - femoropopliteal proximal shunting and recanalization with angioplasty and stenting using biomimetic interwoven nitinol stent in patients with symptomatic peripheral arterial disease at 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operating segment and compare the quality of life of patients after the procedure. It is planned to recruit 110 patients (55 patients in each group). Observation period 2 years. Primary endpoint: -The effectiveness of the method of surgical treatment after 24 months (primary patency, primary-assisted patency, secondary patency). Secondary endpoints: - Clinical efficacy of the method of surgical treatment after 24 months (MALE); - Safety of the method of surgical treatment in the early postoperative period (hematoma of the surgical access area, peripheral neuropathy, purulent-infectious complications of the surgical access area) and after 24 months (MACE); - Assessment of the quality of life in patients after surgical treatment at 6, 12, and 24 months (SF-36 questionnaire); - Evaluation of prognostic factors for adverse outcomes after surgical treatment. |
| смотреть на ClinicalTrials.gov |
| Статус: | Unknown status |
| Фаза: | N/A |
| Начало: | 1 сентября 2020 г. |
| Окончание: | 1 октября 2024 г. |
| Описание: | This is prospective, randomized study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment below the knee, TASC II type D - femoropopliteal distal bypass with a synthetic ePTDE-grafts and recanalization with angioplasty and stenting using a biomimetic intervowen nitinol stent in patients with symptomatic peripheral arterial disease after 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operated segment and compare the quality of life of patients after the procedure. |
| смотреть на ClinicalTrials.gov |
| Статус: | Recruiting |
| Фаза: | N/A |
| Начало: | 30 июня 2020 г. |
| Окончание: | 5 июня 2025 г. |
| Описание: | Hypothesis: "Total" endovascular revascularization of a multistory lesion of the iliac-femoral-popliteal segment is safer and a better quality of life is achieved in comparison with hybrid intervention. The lack of damage to the skin avoids complications in the postoperative and remote periods of observation, thereby improving the quality of life |
| смотреть на ClinicalTrials.gov |