Rheolytic Thrombectomy For Acute Deep Vein Thrombosis Of Whole Lower Limb

ConditionDeep Vein Thrombosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorRenJi Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

pharmacomechanical thrombectomy (PMT)
Device
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.

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: modified access groupExperimental treatment 1 intervention

Group B: traditional access groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of post-thrombotic syndrome (PTS)

Incidence of post-thrombotic syndrome (PTS) at post-interventional 24 months

Time frame

24 months

Secondary outcomes

Immediate patency rate

Percentage of patency rate immediately after lonely mechanical thrombectomy

Time frame

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)

Time frame

immediately after interventional surgery

Total dosage of urokinase

Total dosage measured by units of urokinase used for procedure

Time frame

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

Time frame

post-interventional 12 and 24 months

Other outcomes

Safety outcomes - procedural complications

Procedural complications such as hematoma at the puncture site, hemoglobinuria or hemolytic jaundice

Time frame

Within 30 days after intervention

Safety outcomes - major bleeding events

Major bleeding events according to the International Society on Thrombosis and Haemostasis (ISTH)

Time frame

Within 24 months after intervention

all-cause death

All-cause death during the follow-up period

Time frame

Within 24 months after intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

First People's Hospital of Hangzhou

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Collaborator

Affiliated Hospital of Nantong University

Collaborator

Chengdu University of Traditional Chinese Medicine

Collaborator

Second Affiliated Hospital of Suzhou University

Collaborator

Liuzhou Workers' Hospital

Collaborator

Shanghai Pudong New Area People's Hospital

Collaborator

Zhejiang University

Collaborator

Source ClinicalTrials.gov

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