Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

Официальное название

Clinical Study On The Improvement Of Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb By Primary Popliteal Vein Thrombosis Clearance

Обзор

Ipsilateral popliteal venous the most common access for pharmacomechanical thrombectomy (PMT) in the treatment of acute deep venous thrombosis (DVT), but the result was not satisfactory. The investigators adjust the access to improve the thrombus clearance rate and reduce the incidence of post-thrombotic syndrome (PTS).

Подробное описание

Acute deep venous thrombosis (DVT) with whole lower limb involved is associated with significant post thrombotic morbidity. Both of deep venous occlusion and valvar reflux increase the risk for development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by pharmacomechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, ipsilateral popliteal venous the most common access for PMT. However, from this approach, it's hard to remove the thrombosis in the distal popliteal vein. So, the investigators hypothesize that the residual thrombus and slow blood-flow in the in-flow may weakened the efficacy of PMT, and by adjusting vein access approach could improve the thrombus clearance rate and reduce the incidence of PTS for whole leg DVT.

Вмешательства

• Устройство pharmacomechanical thrombectomy (PMT)
  After randomization patients will be allocated to pharmacomechanical thrombectomy (PMT) via ipsilateral popliteal venous approach or to PMT via distal calf venous approach, bail-out contralateral femoral access can be used if puncture was failed in calf vein. After PMT treatment, residual thrombus was reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) was conducted if there was residual thrombus. Stenosis of iliac vein was assessed by multiangle venography and intravascula

Первичные конечные точки

• Incidence of post-thrombotic syndrome (PTS) [Срок оценки: 24 months]

Вторичные конечные точки (10)

• Immediate patency rate [Срок оценки: immediately after lonely mechanical thrombectomy]
• Total time of interventional surgery [Срок оценки: immediately after interventional surgery]
• Total dosage of urokinase [Срок оценки: immediately after interventional surgery]
• Patency rate of lower limb vein [Срок оценки: post-interventional 12 and 24 months]
• Deep venous valve function evaluation [Срок оценки: post-interventional 12 and 24 months]
• Quality of life evaluated by 36-Item Short Form Health Survey (SF-36) [Срок оценки: post-interventional 3, 6, 12 and 24 months]
• Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score [Срок оценки: post-interventional 3, 6, 12 and 24 months]
• European quality of life 5-dimension 5-level (EQ-5D-5L) score [Срок оценки: post-interventional 3, 6, 12 and 24 months]
• Re-intervention rate [Срок оценки: within 24 months after operation]
• Rate of catheter-directed thrombolysis [Срок оценки: immediately after interventional surgery]

Критерии участия

Критерии включения

• Age between 18-80 years old;
• Acute DVT with clinical symptoms occurred less than 14 days since the onset of disease;
• DVT with thrombosis involving the iliac vein, common femoral vein, distal popliteal vein, and/or calf vein;
• Informed consent signed by patients.

Критерии исключения

• Patients with the previous history of the same side of lower-limb DVT;
• Patients with plasma Creatinine level greater than 180umol/L;
• Patients who are contraindicated to thrombolysis;
• Patients with inferior vena cava thrombosis;
• Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
• Patients who have participated in a clinical trial in the past three months;
• Women during pregnancy and lactation
• Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<2 years);
• Patients with autoimmune thrombopathy or thrombocytopenia (platelets < 80·10⁹/L);
• Patients who are unable or unwilling to participate in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Renji Hospital — Шанхай

Публикации

• Ni Q, Ye X, He C, Zhao H, Lou W, Zhuang H, Sang H, Wu Z, Ye M. Improvement of rheolytic thrombectomy for acute deep vein thrombosis of the whole lower limb by primary popliteal vein thrombosis clearance: protocol for a prospective, multicenter, randomized controlled trial (the Reformation study). BMJ Open. 2025 Jun 3;15(6):e089797. doi: 10.1136/bmjopen-2024-089797. PMID 40461147

Идентификаторы

NCT: NCT05286710 · The Reformation Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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