Deep Vein Thrombosis
Conditions
Keywords
Deep venous thrombosis, Percutaneous mechanical thrombectomy, Post-thrombotic syndrome
Brief summary
The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for iliofemoral deep venous thrombosis (DVT) with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis.
Detailed description
Acute deep venous thrombosis (DVT) is associated with development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by percutaneous mechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, PMT is performed through ipsilateral popliteal venous access as a traditional approach. However, the thrombosis in distal popliteal vein cannot be removed. Previous study demonstrated that the residual thrombus may decrease the efficacy of PMT. The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach for iliofemoral DVT with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.
Interventions
PROCEDUREPercutaneous mechanical thrombectomy (PMT) by the modified approach
The modified approach includes the ipsilateral calf venous access and the contralateral femoral venous access. Through contralateral femoral venous access, a hydrophilic guide wire and a catheter will be crossover through the thrombus side to the distal calf vein. The ipsilateral calf venous access will be punctured under the guidance of ascending venography. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is \>50% stenosis of the diameter of the iliac vein.
PROCEDUREPercutaneous mechanical thrombectomy (PMT) by the traditional approach
The traditional approach will be punctured from the ipsilateral popliteal vein under ultrasound guidance. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is \>50% stenosis of the diameter of the iliac vein.
PROCEDURETraditional approach
The approach will be punctured from either the ipsilateral femoral vein or popliteal vein. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty (PTA) and stenting will be conducted if there is \>50% stenosis of the diameter of the iliac vein.
Sponsors
RenJi Hospital
First People's Hospital of Hangzhou
Chengdu University of Traditional Chinese Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18-85 years old; 2. Acute DVT occurred no more than 14 days since the onset of disease; 3. DVT treated by percutaneous mechanical thrombectomy 4. Informed consent signed by patients.
Exclusion criteria
1. Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent; 2. Women during pregnancy and lactation; 3. Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (\<6 months); 4. Patients who are unable or unwilling to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-thrombotic syndrome | 24-month | Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of catheter-directed thrombolysis | Immediately after interventional surgery | Percentage of catheter-directed thrombolysis after mechanical thrombectomy |
| Total time of interventional surgery | Immediately after interventional surgery | Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis) |
| Total dosage of urokinase | Immediately after interventional surgery | Total dosage measured by units of urokinase used for procedure |
| Patency rate of lower limb vein | 24-month | Percentage of patency rate of lower limb vein evaluated by ultrasound |
| Incidence of post-thrombotic syndrome | 12-month | Incidence of post-thrombotic syndrome (PTS) evaluated by Villalta score |
| Re-intervention rate | 24-month | Percentage of re-intervention rate for the same limb |
Countries
China
Contacts
CONTACTNi Qihong, M.D.
STUDY_DIRECTORNi Qihong, M.D.
Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Outcome results
None listed