Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Deep Vein Thrombosis

Treatments: Device: pharmacomechanical thrombectomy (PMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05286710

The Reformation Study

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

modified access group

Experimental group

Description:

modified access: PMT was performed via distal calf venous access or contralateral femoral access

Treatment:

Device: pharmacomechanical thrombectomy (PMT)

traditional access group

Active Comparator group

Description:

traditional access: PMT was performed via ipsilateral popliteal venous access

Treatment:

Device: pharmacomechanical thrombectomy (PMT)