The Study of Percutaneous Mechanical Thrombectomy Treating Acute Deep Vein Thrombosis of Lower Extremities

Study Overview
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Brief Summary
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This study is a prospective, multicenter, real world, observational study intended to understand tmechanical thrombectomy in the treatment of acute deep venous thrombosis of lower extremities, It is estimated that 600 patients with DVT were enrolled in the group at 24 centers nationwide from May 2022 to May2024. we can obtain data on the incidence of sequelae of deep venous thrombosis after PMT, and analyze the factors that may affect the efficacy of PMT.

Detailed Description
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Through inclusion and exclusion criteria, 600 patients were collected. This experiment was an observational study case series, and no control group was established. The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography. According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation.Postoperative clinical follow-up was performed at 6 months, 12 months, 18 months, and 24 months. The main endpoints were the patency rate of lower extremity deep veins at 6 months after operation and the incidence of PTS (Villalta score) at 2 years after operation.

Official Title
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the Director of Vascular Surgery of Hospital of Chengdu University of Traditional Chinese Medicine

Conditions
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Pharmacomechanical Thrombolysis, Deep Vein Thrombosis

Intervention / Treatment
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* Procedure: Pharmacomechanical thrombolysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The symptoms of deep venous thrombosis of lower extremities occurred within 14 days (including 14 days)； Lower extremity deep venous thrombosis involving iliac vein or / and femoral vein ; Obtain the informed consent of all patients. Exclusion Criteria: Patients with a previous history of ipsilateral proximal lower limb deep venous thrombosis ; patients who are prohibited from thrombolytic therapy; inferior vena cava compression syndrome； Allergic to heparin, low molecular weight heparin or contrast medium; Patients who have participated in clinical trials of other drugs or medical devices that interfere with this clinical trial in the past 3 months; Patients who do not want to participate in this trial; Patients with poor compliance, or those who the researchers think are not suitable for selection.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| post-thromboticsyndrome<br>suffering from PTS (Villalta score) at 2 years after operation. | Procedure: Pharmacomechanical thrombolysis<br>* Pharmacomechanical thrombolysis<br>|
| n-post-thromboticsyndrome<br>none of PTS (Villalta score) at 2 years after operation. | Procedure: Pharmacomechanical thrombolysis<br>* Pharmacomechanical thrombolysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower extremity deep vein patency rate 6 months after operation | The patency of the lower extremity veins was assessed by lower extremity venous ultrasound or lower extremity venography. | 6 months | 
| Incidence of sequelae of deep venous thrombosis after PMT | According to the postoperative symptoms and signs of the patients, the Villata score, (VEINS QoL)/Sym questionnaire and VCSS score were used to understand the PTS situation. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total duration of interventional treatment | Including the entire operation time of interventional surgery | 1 day | 
| Total urokinase dosage | interventional surgery urokinase dosage | 1 day | 
| Lower extremity deep venous patency rate of patients before discharge | The patency rate of lower extremity deep veins in patients 1 week after operation | 1 week | 
| Postoperative quality of life score (QOL) | Postoperative quality of life scoring using the QOL scale | 6 months,12 months,18 months and 24 months | 
| reoperation rate | Reoperation due to thrombosis, pts | 6 months,12 months,18 months and 24 months | 
| Incidence of bleeding complications | Symptoms of perioperative hemorrhage | 1day，7day，3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacomechanical thrombolysis, Deep vein thrombosis, post-thromboticsyndrome