Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

Deep Vein Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286710
• Other study ID #: The Reformation Study
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2023
• Source: RenJi Hospital
• Contact: Ni Qihong, M.D.
• Phone: +8615801900772
• Email: niqihong1989[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 iliac vein, femoral vein popliteal vein and 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

• Patients who are unable or unwilling to participate in the study.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (9)

Lead Sponsor	Collaborator
RenJi Hospital	Affiliated Hospital of Nantong University, Chengdu University of Traditional Chinese Medicine, First People's Hospital of Hangzhou, Liuzhou Workers Hospital, Second Affiliated Hospital of Suzhou University, Shanghai Pudong New Area People's Hospital, The First Affiliated Hospital with Nanjing Medical University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-thrombotic syndrome (PTS)	Incidence of post-thrombotic syndrome (PTS) at post-interventional 24 months	24 months
Secondary	Immediate patency rate	Percentage of patency rate immediately after lonely mechanical thrombectomy	immediately after lonely mechanical thrombectomy
Secondary	Total time of interventional surgery	Total time measured by hours of interventional surgery (Including duration of subsequent catheter directed thrombolysis)	immediately after interventional surgery
Secondary	Total dosage of urokinase	Total dosage measured by units of urokinase used for procedure	immediately after interventional surgery
Secondary	Patency rate of lower limb vein	Percentage of patency rate of lower limb vein at post-interventional 24 months	post-interventional 24 months
Secondary	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 24 months
Secondary	Re-intervention rate	Percentage of re-intervention rate within 24 months after operation	within 24 months after operation
Secondary	Rate of catheter-directed thrombolysis	Percentage of catheter-directed thrombolysis after mechanical thrombectomy	immediately after interventional surgery