Clinical trial NCT05286710: Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb
Official title: Clinical Study On The Improvement Of Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb By Primary Popliteal Vein Thrombosis Clearance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Vein Thrombosis
Keywords: pharmacomechanical thrombectomy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: First People's Hospital of Hangzhou
name: The First Affiliated Hospital with Nanjing Medical University
name: Affiliated Hospital of Nantong University
name: Chengdu University of Traditional Chinese Medicine
name: Second Affiliated Hospital of Suzhou University
name: Liuzhou Workers Hospital
name: Shanghai Pudong New Area People's Hospital
name: Zhejiang University
First posted: 2022-03-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of post-thrombotic syndrome (PTS)
timeFrame: 24 months
Secondary outcomes:
measure: Immediate patency rate
timeFrame: immediately after lonely mechanical thrombectomy
measure: Total time of interventional surgery
timeFrame: immediately after interventional surgery
measure: Total dosage of urokinase
timeFrame: immediately after interventional surgery
measure: Patency rate of lower limb vein
timeFrame: post-interventional 12 and 24 months
measure: Deep venous valve function evaluation
timeFrame: post-interventional 12 and 24 months
measure: Quality of life evaluated by 36-Item Short Form Health Survey (SF-36)
timeFrame: post-interventional 3, 6, 12 and 24 months
measure: Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score
timeFrame: post-interventional 3, 6, 12 and 24 months
measure: European quality of life 5-dimension 5-level (EQ-5D-5L) score
timeFrame: post-interventional 3, 6, 12 and 24 months
measure: Re-intervention rate
timeFrame: within 24 months after operation
measure: Rate of catheter-directed thrombolysis
timeFrame: immediately after interventional surgery
Other outcomes:
measure: Safety outcomes - procedural complications
timeFrame: Within 30 days after intervention
measure: Safety outcomes - major bleeding events
timeFrame: Within 24 months after intervention
measure: all-cause death
timeFrame: Within 24 months after intervention
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Meng Ye, M.D.
role: STUDY_DIRECTOR
References: