Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

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

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).

Study Overview

• Status: Recruiting
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Device: pharmacomechanical thrombectomy (PMT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ni Qihong, M.D.; Phone Number: +8615801900772; Email: niqihong1989@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • RenJi Hospital
      • Contact: Ni Qihong, M.D.; Phone Number: +86 15801900772; Email: niqihong1989@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: modified access group; modified access: PMT was performed via distal calf venous access or contralateral femoral access	Device: 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 intravascular ultrasound (IVUS) was used if necessary. Percutaneous balloon angioplasty (PTA) was conducted if there was >50% stenosis of the diameter of the iliac vein. A stent was placed if the residual stenosis was >50% after PTA treatment.
Active Comparator: traditional access group; traditional access: PMT was performed via ipsilateral popliteal venous access	Device: 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 intravascular ultrasound (IVUS) was used if necessary. Percutaneous balloon angioplasty (PTA) was conducted if there was >50% stenosis of the diameter of the iliac vein. A stent was placed if the residual stenosis was >50% after PTA treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-thrombotic syndrome (PTS)	Incidence of post-thrombotic syndrome (PTS) at post-interventional 24 months	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate patency rate	Percentage of patency rate immediately after lonely mechanical thrombectomy	immediately after lonely mechanical thrombectomy
Total time of interventional surgery	Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)	immediately after interventional surgery
Total dosage of urokinase	Total dosage measured by units of urokinase used for procedure	immediately after interventional surgery
Re-intervention rate	Percentage of re-intervention rate within 24 months after operation	within 24 months after operation
Rate of catheter-directed thrombolysis	Percentage of catheter-directed thrombolysis after mechanical thrombectomy	immediately after interventional surgery
Patency rate of lower limb vein	Percentage of patency rate of lower limb vein at post-interventional 12 and 24 months	post-interventional 12 and 24 months
Deep venous valve function evaluation	Deep venous valve function evaluation by ultrasound at post-interventional 12 and 24 months	post-interventional 12 and 24 months
Quality of life evaluated by 36-Item Short Form Health Survey (SF-36)	Quality of life evaluated by 36-Item Short Form Health Survey (SF-36). The change in SF-36 Physical and Mental Component Scales from baseline to 24 months will be compared between the two groups using a t-test. A difference of 5 points on each scale is considered to be clinically relevant. In addition, a linear mixed model analysis of the repeated assessments (3, 6, 12, and 24 months) with baseline scores as a covariate will be used to investigate the changes over time, and if they differ by treatment arm.	post-interventional 3, 6, 12 and 24 months
Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score	Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) score at post-interventional 24 months; The minimum value is 21, and the maximum value is 118. The higher scores mean a better outcome.	post-interventional 3, 6, 12 and 24 months
European quality of life 5-dimension 5-level (EQ-5D-5L) score	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	post-interventional 3, 6, 12 and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcomes - procedural complications	Procedural complications such as hematoma at the puncture site, hemoglobinuria or hemolytic jaundice	Within 30 days after intervention
Safety outcomes - major bleeding events	Major bleeding events according to the International Society on Thrombosis and Haemostasis (ISTH)	Within 24 months after intervention
all-cause death	All-cause death during the follow-up period	Within 24 months after intervention

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Liuzhou Workers Hospital; First People's Hospital of Hangzhou; Chengdu University of Traditional Chinese Medicine; Zhejiang University; Second Affiliated Hospital of Suzhou University; Affiliated Hospital of Nantong University; Shanghai Pudong New Area People's Hospital
• Investigators: Study Director: Meng Ye, M.D., Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: pharmacomechanical thrombectomy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: The Reformation Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No